Wholehearted Approach
VASCULAR
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A WHOLE HEARTED APPROACH TO
COMPLEX PCI

A PASSIONATE COMMITMENT TO YOU AND COMPLEX PCI

At Abbott, we’re focusing all of our energy on working with you to overcome the challenging lesions you encounter in your PCI procedures. We’re committed to bring you the solutions you need to get the very best outcomes for your patients. It’s all part of our wholehearted approach to complex PCI.

For Important Safety Information, please click here.

ACS

 
 
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SIDE BRANCH ACCESS

An estimated 20% of percutaneous coronary interventions (PCIs) involve a side branch1

Compared with simple lesions, those involving a side branch have been associated with:

  • Lower procedural success rates2, 3
  • Higher adverse event rates2
  • Longer procedures2, 3
  • No angiographic benefit and worse clinical outcome3

Physiological assessment and procedure planning are paramount to successfully preserving side branch access.

Abbott is committed to giving you tools that can assist you in:

Physiological Assessment:

Quantien Integrated FFR System

  • FFR assessment can be utilized in the selection of appropriate side branches for revascularization4
  • A physiologic evaluation of side branch disease can overcome the limitations of anatomical evaluations and address the uniqueness of side branch lesions4
  • FFR guides management of jailed side branches8 and can detect residual ischemia after side branch stenting5

FFR-guided percutaneous coronary intervention is the gold standard for lesion assessment.6

Navigation and Device Delivery:

OPTIS Integrated System

  • OCT guided PCI reduces strut malapposition5
  • OCT may be superior and easier to interpret in side branch access than IVUS for the evaluation of the side branch ostium, stent positions, stent expansion, malapposition, wire positions, and in the detection of thrombus6,7
  • OCT provides intra-lesion detail with real-time OCT 3-D visualization

XIENCE Sierra

  • The multi-link design has the greatest side branch access in workhorse size stents9

Guide Wires

  • Our comprehensive family of guide wires offer excellent torque control with moderate support that enables a smooth transition to access side branches

Education and Training:

Educational Programs

PCI Masters Course

This course is designed for physicians interested in learning more about PCI procedures. Some of the topics to be covered:

  • How to deliver complete revascularization
  • The expanded PCI Toolbox
  • Lesion specific treatments
  • Practical application of Guide Wires, Guide Extensions, and Micro Catheter use
  • Complication Management
  • Patients who will benefit from revascularization therapy

Request more information here: https://www.avsolutionscenter-signup.com/


FFR - fractional flow reserve OCT - optical coherence tomography PCI - precutaineous coronary syndrome CTO - chronic total occlusion

1. Sawaya FJ, et al. JACC Card Interv 2016;9(18):1861-1878 2. Louvard Y, et al. Heart 2004;90:713-722. 3. Iakovou I, et al. Herz 2011;36(3):198-213 . 4. Koo BK, Park KW, Kang HJ, et al. Physiological evaluation of the provisional side-branch intervention strategy for bifurcation lesions using fractional flow reserve. Eur Heart J 2008; 29: 726–732 Park SH, et al. J Geriatr Cardiol 2012;9:278-284. 5. Alegría-Barrero E, et al. EuroIntervention 2012;8(2):205-213. 6. Costantini CR, et al. International Journal of Cardiology and Cardiovascular Medicine Fractional Flow Reserve: Should be the Gold Standard for Therapeutic Definition of Coronary Artery Disease? 2018 7. Lassen, et al. EuroIntervention 2018;13:1540-1553. 8. Koo BK, et al. Coronary Physiology in the Catheterization Laboratory 2013. 9. Test performed by and data on file at Abbott. Workhorse sizes refers to 3.0mm diameter.

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Calcification

 
 
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CALCIFICATION

Calcium is a growing problem in the treatment of coronary artery disease. Pooled analysis from the HORIZONS-AMI and ACUITY Trials suggests patients with moderate/severe calcium have a significantly higher chance of death, TLR, and MACE.1

Calcified vessels have the potential to limit device and procedural success. Coronary calcification results in impaired stent delivery, decreased stent expansion, increased malapposition and stent asymmetry, increased procedural complications, and increased rates of stent thrombosis and restenosis.2,3

Assessment and navigation are important steps in achieving revascularization and improving procedural outcomes.

Abbott is committed to giving you tools that can assist you in:

Calcium Assessment:

OPTIS Integrated System

  • OCT can assess calcium thickness and measure calcium volume2
  • OCT assessment can guide your therapy and help you plan your procedure

Navigation and Device Delivery:

Guide wires

  • Our comprehensive family of guide wires provides tip redirective properties that allow for crossability even in calcified lesions

XIENCE Sierra

  • 3-link design provides excellent radial and longitudinal strength for calcified lesions4
  • Its durable and protective fluoropolymer is proven to be most thromboresistant5
  • The XIENCE Fluoropolymer Stent Coating Promotes Best-in-Class Safety And Healing6

Education and Training:

Educational Programs

OPTIS Integrated System Workshop for Physicians

This course is designed for physicians interested in learning more about optical coherence tomography (OCT) and fractional flow reserve (FFR) in their daily practice. Program faculty will review the OPTIS Integrated System for OCT and FFR applications, including image interpretation and best practices.

Request more information here: https://www.avsolutionscenter-signup.com/


1. Genereux P, Madhaven MV, Mintz GS, et al. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes: Pooled analysis from the HORIZONS AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trials. J Am Coll Cardiol. 2014; 63:1845–1854 2. Madhavan MV, et al. J Am Coll Cardiol 2014;63(17):1703-1714. 3. Kirtane A. CHIP 2017 4. Tests performed by and data on file at Abbott. 5. Otsuka, Fumiyuki, et al. "Acute thrombogenicity of a durable polymer everolimus-eluting stent relative to contemporary drug-eluting stents with biodegradable polymer coatings assessed ex vivo in a swine shunt model."JACC: Cardiovascular Interventions8.9 (2015): 1248-1260. Notes: Pre-clinical study using an ex vivo porcine shunt model with platelet aggregation evaluated by confocal microscopy with immunofluorescent staining against dual platelet markers (CD61/CD42b) along with scanning electron microscopy. Comparison with Synergy™ (n=6), Orsiro™ (n=6), and XIENCE (n=24). 6. Palmerini, et al. The Lancet. 379:9824, 14-20 April 2012, pp. 1393-1402; Bangalore S, et al. Circ Cardiovasc Interv, Aug 6, 2013. doi: 10.1161/ circinterventions.113.000415.; Valgimigli, Effects of Cobalt-chromium Everolimus eluting or bare metal stent on fatal and non-fatal cardiovascular events. A patient-level meta analysis. EuroPCR 2014; Serruys, PW et al. RESOLUTE All Comers Trial, NEJM 2010. Published online June 16, 2010; Fajadet, J., et al. PLATINUM PLUS 30-day Poster, TCT 2012.

LEARN MORE ABOUT ABBOTT'S PORTFOLIO OF PRODUCTS

Left Main

 
 
CTO

CTOs can occur between 30%-52% of patients with significant coronary artery disease.1,2

Recent meta-analyses and large registries have shown that successful CTO PCI is associated with symptom relief, and a lower need for coronary artery bypass graft (CABG) surgery.3,4

Some of the challenges associated with CTO PCI include cap penetration, occlusion navigation, and higher rates of thrombosis and restenosis.5

Abbott is committed to helping you with some of these challenges by providing you our tools indicated for CTO PCI:

XIENCE Sierra

  • XIENCE is the only CTO-indicated stent in the US market
  • XIENCE Sierra is the latest version in our XIENCE family of stents
  • Demonstrated a 1.4% ARC Definite/Probable Stent Thrombosis rate at 4 years in the all-CTO trial EXPERT CTO, including 0% ARC Definite Stent Thrombosis after 30 days6
  • Outperformed the Orsiro BP-DES in the all-CTO trial PRISON IV, as Orsiro failed to demonstrate non-inferiority compared to XIENCE7

GUIDE WIRES

  • The full polymer jacket of the Pilot family of wires can aid in smooth tracking of tortuous vessels and in crossing tight lesions
  • Hi-TORQUE Progress wires were designed to provide increasing penetration power to navigate very highly stenosed lesions and chronic total occlusions

MINI TREK RX, MINI TREK OTW
BALLOON DILATATION CATHETERS

  • Built for complex lesions with an ultra-low profile design it delivers superb flexibility and lesion access8
  • 1.20mm - 2.0mm indicated for treatment of CTO
  • Ultra-low profile design delivers superb flexibility and lesion access8

    A REVOLUTIONARY FAMILY OF BALLOONS DEVELOPED TO DELIVER OUTSTANDING PERFORMANCE IN COMPLEX AND CHALLENGING CASES8

Education and Training:

Educational Programs

CTO Course

The CTO training program is to train interested physicians to become competent hybrid CTO operators. The curriculum includes classroom, live case, and proctorship courses.

Request more information here: https://www.avsolutionscenter-signup.com/


1. Garratt, K. Chronic Total Occlusion of the Coronary Artery. Centers for Disease Control and Prevention, US Dept of Health and Human Services; 2006. 2. Christofferson RD, Lehmann KG, Martin GV, et al. Effect of chronic total occlusion on treatment strategy. Am J Cardiol. 2005; 95:1088-1091. 3. Mehran R, Claessen BE, Godino C, et al. Long-term outcome of percutaneous coronary intervention for chronic total occlusions. JACC Cardiovasc Interv. 2011;4(9):952-961. 4. Sudhakar G, MD. Long-term follow-up of elective chronic total coronary occlusion angioplasty: analysis 5. Brilakis E et al. Manual of Chronic Total Occlusion Interventions. A Step-by-Step Approach. 2nd Edition. 2018; xvii;5. 6. Kandzari D et al. “Safety and Effectiveness of XIENCE Stents in Chronic Total Occlusion Revascularization: 4 Year Results from the EXPERT CTO Multicenter Clinical Trial”, TCT 2017. 7. Teeuwen K et al. “PRISON IV” Trial. JACC Cardiovasc Interv. 2017;10:133-143 8. Tests performed by and data on file at Abbott.


LEARN MORE ABOUT ABBOTT'S PORTFOLIO OF PRODUCTS

Educational Resources

 
 
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EDUCATION COURSES

Avademics

Avademics, Abbott’s premier educational resource program, was developed in partnership with healthcare professionals to provide best-in-class training courses. As a leader in innovative training programs, Avademics offers an impressive educational portfolio, for both Endovascular and Coronary Interventions for today’s cardiovascular interventional teams, that include physicians, fellows, and cath lab staff.

The mission is to provide exceptional educational programs that address today’s clinical, technical, and procedural challenges, with the ultimate end goal of improving patient outcomes.

Abbott’s coronary educational portfolio includes:

  • PCI Masters Courses
  • OPTIS OCT & FFR Courses
  • Complex PCI Courses
  • CTO Courses
  • Fellow Courses


Expert Perspectives

 
 
EXPERT PERSPECTIVES: WHAT'S THE FUTURE OF COMPLEX PCI?

"I think the future of Complex PCI will continue to thrive..."



"...being able to case-plan beforehand in order to have an optimal outcome with a complicated case."



"...focusing on patients that have high-risk patient characteristics, such as diabetes, and high-risk lesions."

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION

rx-only-logo HI-TORQUE Guide Wires

INTENDED USE

All Hi-Torque Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

INDICATIONS

Refer to the device label for any additional product-specific indications that may apply.

CONTRAINDICATIONS

HI-TORQUE Guide Wires are not intended for use in the cerebral vasculature.

Refer to the device label for any additional product-specific contraindications that may apply.

WARNINGS

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and/or reuse.

 

Carefully observe the instructions under "Do Not" and "Do" below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.

Do Not:

  • Push, auger, withdraw or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel with the vessel wall.
  • Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts into a bifurcated vessel. Use of this technique carries additional patient risks, including the risk that the wire may become caught on the stent strut.
  • Consider that if a secondary wire is placed in a bifurcation branch, this wire may need to be retracted prior to stent deployment because there is additional risk that the secondary wire may become entrapped between the vessel wall and the stent.

PRECAUTIONS

Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.

Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC Guide Wire Extension.

HI-TORQUE Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating.
Do not withdraw or manipulate the hydrophilic-coated wire in a metal cannula or sharp-edged object.

ADVERSE EVENTS

Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

rx-only-logo HI-TORQUE Guide Wires for PTCA, PTA, and Stents

INDICATIONS FOR USE

This HI-TORQUE Guide Wire is intended to facilitate the placement of balloon dilatation catheters during Percutaneous Transluminal Coronary Angioplasty (PTCA) and Percutaneous Transluminal Angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

CONTRAINDICATIONS

Not intended for use in the cerebral vasculature or with atherectomy devices.

WARNINGS

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take reme­dial action as needed. Use the most suitable guide wire for the lesion being treated.

Do Not:

  • Push, auger, withdraw, or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel with the vessel wall.
  • Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts into a bifurcated vessel. Use of this technique carries additional patient risks, includ­ing the risk that the wire may become caught on the stent strut.
  • Consider that if a secondary wire is placed in a bifurcation branch, this wire may need to be retracted prior to stent deployment because there is additional risk that the secondary wire may become entrapped between the vessel and the stent.

PRECAUTIONS

Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.

Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC Guide Wire Extension.

HI-TORQUE Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire in a metal cannula or sharp-edged object.

rx-only-logo HI-TORQUE Guide Wires for PTCA, PTA, and Stents

INDICATIONS FOR USE

This HI-TORQUE Guide Wire is intended to facilitate the placement of balloon dilatation catheters during Percutaneous Transluminal Coronary Angioplasty (PTCA) and Percutaneous Transluminal Angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

CONTRAINDICATIONS

Not intended for use in the cerebral vasculature or with atherectomy devices.

WARNINGS

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take reme­dial action as needed. Use the most suitable guide wire for the lesion being treated.

Do Not:

  • Push, auger, withdraw, or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.
  • Deploy a stent such that it will entrap the wire between the vessel wall and the stent.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel with the vessel wall.
  • Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts into a bifurcated vessel. Use of this technique carries additional patient risks, including the risk that the wire may become caught on the stent strut.

PRECAUTIONS

Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.

Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC Guide Wire Extension.

HI-TORQUE Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire in a metal cannula or sharp-edged object.

ADVERSE EVENTS

Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

rx-only-logo HI-TORQUE ADVANCE Guide Wires

INDICATIONS FOR USE

The HI-TORQUE ADVANCE Guide Wires are intended to facilitate the placement of interventional percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) catheters, and other interventional devices including: intravascular stents, intravascular ultrasound devices and intravascular drug eluting stents.

CONTRAINDICATIONS

The HI-TORQUE ADVANCE Guide Wires are not intended for use in the cerebral vasculature.

WARNINGS

This device is designed and intended for ONE TIME USE ONLY. Do not resterilize and/or reuse.

Carefully observe the instructions under "Do Not" and "Do" below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.

Do Not:

  • Push, auger, withdraw or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and/or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel with the vessel wall.
  • Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts into a bifurcated vessel. Use of this technique carries additional patient risks, including the risk that the wire may become caught on the stent strut.
  • Consider that if a secondary wire is placed in a bifurcation branch, this wire may need to be retracted prior to stent deployment because there is additional risk that the secondary wire may become entrapped between the vessel wall and the stent.

PRECAUTIONS

Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and/or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.

Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC Guide Wire Extension.

Avoid abrasion of the hydrophilic coating.

Do not withdraw or manipulate the hydrophilic-coated wire in a metal cannula or sharp-edged object.

ADVERSE EVENTS

Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

rx-only-logo HI-TORQUE PROGRESS, HI-TORQUE PILOT Guide Wires for PTCA, PTA, Stents, CTO

INDICATIONS FOR USE

Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. This guide wire may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO).

CONTRAINDICATIONS

Not intended for use in the cerebral vasculature or with atherectomy devices.

WARNINGS

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.

Do Not:

  • Push, auger, withdraw, or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall.
  • Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts, into a bifurcated vessel. Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.
  • Consider that if a secondary wire is placed in a bifurcation branch, this wire may need to be retracted prior to stent deployment, because there is additional risk that the secondary wire may become entrapped between the vessel wall and the stent.

 

For the PROGRESS family only: The PROGRESS family of guide wires has distal ends of varying stiffness. Operate these guide wires carefully so as to not injure the blood vessel, observing the information in these instructions. The higher torque performance, stiffer distal ends, and / or higher advancement force may present a higher risk of perforation or injury than a guide wire with a more pliable distal end. Therefore, use the guide wire with the least stiff distal end that will treat the lesion, and use extreme care to minimize the risk of perforation or other damage to blood vessels.

PRECAUTIONS

Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.

Never attach the torque device to the modified portion of the proximal end of the extendible guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC Guide Wire Extension.

Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.

OBSERVED ADVERSE EVENTS

During the EXPERT CTO trial, for the guide wire related objective of the study, In-hospital MACE (per ARC MI definition) occurred in 10.87% (15/138) of the subjects, with 0.72% (1/138) experiencing clinically-driven target lesion revascularization (TLR), 10.87% (15/138) experiencing MI, and no in-hospital death. In-hospital MACE (per protocol MI definition) occurred in 2.17% (3/138) of the subjects, with 0.72% (1/138) experiencing clinically-driven TLR, 1.45% (2/138) experiencing MI, and no in-hospital death.

rx-only-logo HI-TORQUE Guide Wires for PTCA, PTA, and Stents

INDICATIONS FOR USE

This HI-TORQUE guide wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures. The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

CONTRAINDICATIONS

Not intended for use in the cerebral vasculature.

WARNINGS

Not intended for use with atherectomy devices.

Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.

Do Not:

  • Push, auger, withdraw, or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.
  • Deploy a stent such that it will entrap the wire between the vessel wall and the stent.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall.
  • Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts, into a bifurcated vessel. Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.

PRECAUTIONS

Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.

Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC Guide Wire Extension.

HI-TORQUE Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.

ADVERSE EVENTS

Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

rx-only-logo HI-TORQUE TURNTRAC Guide Wire

INDICATIONS FOR USE

This HI-TORQUE guide wire is intended to facilitate the delivery of catheter-based interventional devices during the following procedures:

 

  • Percutaneous transluminal angioplasty (PTA)
  • Percutaneous transluminal coronary angioplasty (PTCA)

This guide wire may also be used with compatible stent devices.

 

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

CONTRAINDICATIONS

Not intended for use in the cerebral vasculature.

WARNINGS

Not intended for use with atherectomy devices.

Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.

Do Not:

  • Push, auger, withdraw, or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.
  • Deploy a stent such that it will entrap the wire between the vessel wall and the stent.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall.
  • Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts, into a bifurcated vessel. Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.

PRECAUTIONS

Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.

This device should be used only by physicians trained in angiography and percutaneous transluminal coronary angioplasty (PTCA), and / or percutaneous transluminal angioplasty (PTA).

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.

Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC Guide Wire Extension.

HI-TORQUE Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.

ADVERSE EVENTS

Potential adverse events associated with use of this device may include the following but not limited to:

  • Perforation
  • Dissection
  • Occlusion
  • Myocardial infarction
  • Embolism
  • Infection
  • Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, device materials, and drug reactions to anticoagulation, or antiplatelet drugs
  • Vasoconstriction
  • Vasospasm
  • Hypotension
  • Hypertension

 

rx-only-logo HI-TORQUE VERSATURN Guide Wire

INDICATIONS FOR USE

This HI-TORQUE guide wire is intended to facilitate the delivery of catheter-based interventional devices during the following procedures:

 

  • Percutaneous transluminal angioplasty (PTA)
  • Percutaneous transluminal coronary angioplasty (PTCA)

This guide wire may also be used with compatible stent devices.

 

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

CONTRAINDICATIONS

Not intended for use in the cerebral vasculature.

WARNINGS

Not intended for use with atherectomy devices.

Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.

Do Not:

  • Push, auger, withdraw, or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.
  • Deploy a stent such that it will entrap the wire between the vessel wall and the stent.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall.
  • Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts, into a bifurcated vessel. Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.

PRECAUTIONS

Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.

Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC Guide Wire Extension.

HI-TORQUE Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.

ADVERSE EVENTS

Potential adverse events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

rx-only-logo HI-TORQUE WIGGLE Guide Wire

INTENDED USE

The HI-TORQUE WIGGLE Guide Wire is intended to facilitate the placement of the catheter by orienting the catheter tip during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and other interventional diagnostic or therapeutic procedures.

INDICATIONS

Refer to the device label for any additional product-specific indications which may apply.

CONTRAINDICATIONS

The HI-TORQUE WIGGLE Guide Wire is not intended for use in the cerebral vasculature. Refer to the device label for any additional product-specific contraindications which may apply.

WARNINGS

This device is designed and intended for ONE-TIME USE ONLY. DO NOT RESTERILIZE AND / OR REUSE. Observe all guide wire movement in the vessels. Before a guide wire is moved or torqued, the tip movement should be examined under fluoroscopy. Do not torque a guide wire without observing corresponding movement of the tip; otherwise, vessel trauma may occur.
Torquing a guide wire against resistance may cause guide wire damage and / or guide wire tip separation. Always advance or withdraw the guide wire slowly. Never push, auger, withdraw or torque a guide wire which meets resistance. Resistance may be felt and / or observed under fluoroscopy by noting any buckling of the guide wire tip. Determine the cause of resistance under fluoroscopy and take any necessary remedial action.

If the wire tip becomes entrapped within the vasculature, DO NOT TORQUE THE GUIDE WIRE.

Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform all exchanges slowly to prevent air entry and / or trauma.

When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and not against the vessel wall. Failure to do so may result in vessel trauma upon guide wire exit of the device. Use the radiopaque marker of the interventional device to confirm position.

PRECAUTIONS

Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged wires. Using a damaged wire may result in vessel damage and / or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use. Test the system for any resistance prior to use. Mild to moderate resistance may be felt as the HI-TORQUE WIGGLE Guide Wire waves are advanced or retracted through the catheter. If severe resistance is encountered, it may be necessary to change to a catheter having a larger guide wire lumen.

Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC Guide Wire Extension.

ADVERSE EVENTS

Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

rx-only-logo OptisTM

Integrated System, Mobile System, Software

INDICATIONS

The OPTIS Integrated System and Mobile System with OPTIS Software combined with Dragonfly™ DUO or Dragonfly™ OPTIS™ Imaging Catheter are intended for the imaging of coronary arteries and are indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly DUO or Dragonfly OPTIS Imaging Catheter are intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The OPTIS Integrated System and Mobile System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

CONTRAINDICATIONS

The OPTIS Integrated System and Mobile System with OPTIS Software are contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:

  • Bacteremia or sepsis
  • Major coagulation system abnormalities
  • Patients diagnosed with coronary artery spasm
  • Patients disqualified for CABG surgery
  • Patients disqualified for PTCA
  • Severe hemodynamic instability or shock
  • Total occlusion
  • Large thrombus
  • Acute renal failure

NOTE: The system has no patient alarm functions. Do not use for cardiac monitoring.

WARNINGS

  • Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
  • Observe all advancement and movement of the Dragonfly Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage.
  • Leave the guidewire engaged with the catheter at all times during use. Do not withdraw or advance the guidewire prior to withdrawing the catheter.
  • If resistance is encountered during advancement or withdrawal of the Dragonfly Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter and guidewire together.
  • The catheter should never be forced into lumens that are narrower than the catheter body or forced through a tight or heavily calcified lesion.
  • The catheter should not be advanced through abnormally tortuous anatomy.
  • When advancing or retracting a catheter with a minirail tip through a stented vessel, the catheter may engage the stent between the junction of the catheter and guidewire, resulting in entrapment of catheter/guidewire, catheter tip separation, and/or stent dislocation.
  • Refer to the contrast media’s instructions-for-use for general warnings and precautions relating to use of the contrast media.

PRECAUTIONS

  • Safety and effectiveness have been established for the following patient population: adult patients undergoing non-emergent percutaneous coronary interventions in lesions with reference vessel diameters between 2.0 to 3.5 mm, which were not located in the left main coronary artery or in a target vessel which has undergone previous bypass procedures.
  • All operators must be trained prior to using the OPTIS Integrated System, the OPTIS Mobile System and the Dragonfly Imaging Catheter.
  • Only 100% contrast media is approved for human use.
  • Store the catheter at ambient temperature in a dry location out of direct sunlight.
  • Never attempt to attach or detach a catheter to the DOC while the “lock” LED is lit.
  • Do not kink, sharply bend, pinch, or crush the catheter at any time.
  • The catheter is for single use only. Do not reuse, re-sterilize, or reprocess.
  • The catheter is sterilized by ethylene oxide and is intended for one time use only. Non-pyrogenic. Do not use if the package is opened or damaged.
  • After use, the catheter may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
  • The catheter has no user serviceable parts. Do not attempt to repair or alter any part of the catheter assembly as provided.

POTENTIAL ADVERSE EVENTS (AEs)

Potential complications which may be encountered during all catheterization procedures include, but are not limited to: acute myocardial infarction or unstable angina, allergic reaction to the contrast media, arterial dissection, injury, or perforation, cardiac arrhythmias, coronary artery spasm, embolism, thrombus formation, or death.

rx-only-logo PressureWireTM X Guidewire

INDICATIONS

The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X guidewire can also measure blood temperature.

CONTRAINDICATIONS

This guidewire is contraindicated for use in the cerebral vasculature.

WARNINGS

  • No modification of this device is allowed.
  • The PressureWire™ X guidewire is supplied sterile. Discard the guidewire if the pouch is opened or damaged, compromising the sterile barrier. The guidewire is designed for single use only and shall not be reused or resterilized. Adverse effects of using a non-sterile or resterilized guidewire may include, but are not limited to:
    • Local and/or systemic infection
    • Mechanical damage
    • Inaccurate readings
  • Observe all guidewire movements. Whenever the guidewire is moved or torqued, the tip movement should be examined under fluoroscopy. Never push, withdraw, or torque the guidewire if it meets resistance or without observing corresponding movement of the tip, otherwise vessel/ventricle trauma may occur.
  • Torquing or excessive manipulation of the guidewire in a sharp bend, against resistance, or repeated attempts to cross a total vessel occlusion may:
    • Cause dissection or perforation of blood vessels
    • Cause vessel spasm
    • Damage and/or fracture the guidewire
  • When introducing the guidewire, flush the catheter and administer anticoagulation as for a standard catheterization procedure or clotting may occur.
  • Do not use the guidewire in the ventricles if the patient has a prosthetic mechanical or biological valve. It may result in damage to both the prosthesis and the guidewire, which may cause injury or death.
  • Use of the PressureWire™ X guidewire in conjunction with interventional devices with a short rapid exchange may result in a folded or fractured guidewire.
  • High frequency surgical devices must not be used on a patient at the same time as the guidewire.

PRECAUTIONS

  • The PressureWire™ X guidewire is a delicate instrument and should be handled carefully.
  • Make sure that the transmitter is kept dry to ensure accurate pressure and/or temperature readings. Inaccurate readings may necessitate device replacement.
  • Do not use the guidewire in conjunction with atherectomy catheters. It may damage the guidewire.
  • Do not withdraw or manipulate the guidewire in a sharp-edged object. It may result in abrasion of the guidewire coating.
  • Factors that may affect the accuracy of the diagnostic information include, but are not limited to:
    • Improper placement of the aortic pressure sensor.
    • Failure to achieve maximum coronary and myocardial hyperemia.
    • Blood flow affected by the position of interventional devices, such as balloon catheters.
  • Guidewire readings may be affected by defibrillation. Rezero the guidewire after defibrillation use.
  • Do not measure pressure when the guidewire sensor element is in a sharp bend or in contact with atrial or ventricular walls. It might result in pressure artifacts.
  • Do not use the PressureWire™ X guidewire together with another guidewire, for so called jailed wire technique, due to difficulty in guidewire withdrawal and possible guidewire entrapment.
  • Store at room temperature in a dry and dark place.

POTENTIAL ADVERSE EVENTS

Potential complications which may be encountered during all catheterization procedures include, but are not limited to: vessel dissection or occlusion, perforation, embolus, spasm, local and/or systemic infection, pneumothorax, congestive heart failure, myocardial infarction, hypotension, chest pain, renal insufficiency, serious arrhythmias, or death.

rx-only-logo QUANTIENTM Measurement System

INTENDED USE

The QUANTIEN™ system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices.

INDICATIONS

The QUANTIEN™ Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.

The QUANTIEN™ Measurement System is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

CONTRAINDICATIONS

The device has no patient alarm functions. Do not use it for cardiac monitoring.

WARNINGS

  • No modification of this equipment is allowed.
  • Do not open or remove access covers on the QUANTIEN™ system unless specifically instructed by St Jude Medical technical support to do so.
  • External equipment intended for connection to signal input, signal output or other connectors, shall comply with relevant IEC standard (e.g., IEC 60601 series for medical electrical equipment). In addition, all such combinations of systems shall comply with the standard IEC 60601-1-1, Safety requirements for medical electrical systems, alternatively IEC 60601-1 ed.3 §16, ME SYSTEMS. Any person who connects external equipment to signal output, or other connectors, has formed a system and is therefore responsible for compliance of the system with these requirements.
  • Do not use the QUANTIEN system if it has been dropped or in any other way exposed to mechanical or electrical damage. This can cause the user or patient to be exposed to electric shock or cause faulty readings of data.
  • High frequency surgical equipment must not be used on a patient at the same time as PressureWire™ guidewire and the QUANTIEN system.
  • Do not use the QUANTIEN system if liquid is suspected to have penetrated the enclosure or the power supply unit. This can cause the user or patient to be exposed to electric shock.
  • Do not sterilize the QUANTIEN system or any of its parts.
  • Do not use this system or any of its parts if it has been sterilized.
  • The QUANTIEN system contains a lithium battery for the system real-time clock. Danger of explosion. Battery is not intended to be replaced

PRECAUTIONS

  • The QUANTIEN™ system is Type CF equipment and protected against the effects of a discharge of a defibrillator. PressureWire guidewire readings may be affected by defibrillation. After defibrillation restart procedure, i.e. re-zero and re-equalize PressureWire guidewire.
  • If it is necessary to install the QUANTIEN system adjacent to other equipment, this system should be observed to verify normal operation. If abnormal performance is observed, it is necessary to increase distance between equipment.

POTENTIAL ADVERSE EVENTS

Potential complications which may be encountered during all catheterization procedures include, but are not limited to: acute myocardial infarction or unstable angina, allergic reaction to the contrast media, arterial dissection, injury, or perforation, cardiac arrhythmias, coronary artery spasm, embolism, thrombus formation, or death.

rx-only-logo Trek & Mini Trek Coronary Dilatation Catheter

TREK RX & OTW and MINI TREK RX & OTW and MINI TREK II OTW Coronary Dilatation Catheter

CAUTION

CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. OBSERVE ALL WARNINGS AND PRECAUTIONS NOTED THROUGHOUT THESE INSTRUCTIONS. FAILURE TO DO SO MAY RESULT IN COMPLICATIONS.

INDICATIONS

Applies to TREK RX & OTW 2.25 mm – 5.00 mm sizes only:

The TREK RX & OTW Coronary Dilatation Catheters are indicated for:

  • Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion
  • Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction
  • Balloon dilatation of a stent after implantation

Applies to MINI TREK RX & OTW and MINI TREK II OTW 1.50 mm – 2.00 mm sizes only:

The MINI TREK RX & OTW and MINI TREK II OTW Coronary Dilatation Catheters are indicated for:

  • Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion
  • Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction
  • Balloon dilatation of a stent after implantation (balloon model 2.0 mm only)
  • Balloon dilatation of de novo chronic total coronary occlusions (CTO)

Applies to MINI TREK RX & OTW and MINI TREK II OTW 1.20 mm sizes only:

The MINI TREK RX & OTW and MINI TREK II OTW 1.20mm Coronary Dilatation Catheters are indicated for:

  • Initial balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis).
  • Balloon dilatation of de novo chronic total coronary occlusions (CTO)

Note (applies to 2.00 mm to 5.00 mm only): Post-deployment stent expansion testing was performed on the bench with the MULTI-LINK VISION® and MULTI-LINK ULTRA® stents. All stents should be deployed in accordance with the manufacturer’s indications and instructions for use.

CONTRAINDICATIONS (APPLIES TO ALL SIZES)

The TREK RX & OTW, MINI TREK RX & OTW and MINI TREK II OTW Coronary Dilatation Catheters are not intended to be used to treat patients with:

  • An unprotected left main coronary artery
  • A coronary artery spasm in the absence of a significant stenosis

WARNINGS (APPLIES TO ALL SIZES)

This device is intended for one time use only. DO NOT resterilize and / or reuse it, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing.

Percutaneous transluminal coronary angioplasty (PTCA) should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication.

PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful consideration, including possible hemodynamic support during PTCA, as treatment of this patient population carries special risk.

Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon.

Balloon pressure should not exceed the rated burst pressure (RBP). The RBP is based on results of in vitro testing. At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their RBP. Use of a pressure-monitoring device is recommended to prevent over pressurization.

To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.

When the catheter is exposed to the vascular system, it should be manipulated while under high quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met during manipulation, determine the cause of the resistance before proceeding.

Do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking. Instead, prepare a new catheter.

Do not torque the catheter more than one (1) full turn.

In the event of catheter damage / separation, recovery of any portion should be performed based on physician determination of individual patient condition and appropriate retrieval protocol.

Treatment of moderately or heavily calcified lesions is considered to be moderate risk, with an expected success rate of 60 – 85% and increases the risk of acute closure, vessel trauma, balloon burst, balloon entrapment, and associated complications. If resistance is felt, determine the cause before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.

PRECAUTIONS (APPLIES TO ALL SIZES, EXCEPT AS NOTED)

Note the “Use by” date specified on the package.

Inspect all product prior to use. Do not use if the package is open or damaged.

This device should be used only by physicians trained in angiography and PTCA, and / or percutaneous transluminal angioplasty (PTA).

Prior to angioplasty, the dilatation catheter should be examined to verify functionality and ensure that its size is suitable for the specific procedure for which it is to be used.

During the procedure, appropriate anticoagulant and coronary vasodilator therapy must be provided to the patient as needed. Anticoagulant therapy should be continued for a period of time to be determined by the physician after the procedure.

If the surface of the TREK RX & OTW, MINI TREK RX & OTW or MINI TREK II OTW Coronary Dilatation Catheter becomes dry, wetting with heparinized normal saline will reactivate the coating.

Do not reinsert the TREK RX & OTW, MINI TREK RX & OTW or MINI TREK II OTW Coronary Dilatation Catheter into the coil dispenser after procedural use.

The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) have not been established.

Applies to TREK RX and MINI TREK RX only (APPLIES TO ALL SIZES), in addition to above:

The design and construction of these catheters do not provide the user with distal pressure monitoring capability.

Applies to TREK RX 4.50mm and 5.00mm sizes only, in addition to above:

With 4.5 mm and 5.0 mm balloon dilatation catheters, some increased resistance may be noted upon insertion or withdrawal into or out of the guiding catheter. Choosing a larger guiding catheter size may minimize this.

Applies to TREK OTW, MINI TREK OTW and MINI TREK II OTW (APPLIES TO ALL SIZES), in addition to above:

Bench testing was conducted with 0.014” (.36mm) constant diameter guide wires to establish guide wire compatibility. If another type of guide wire is selected with a different dimensional profile, the compatibility (e.g., wire resistance) should be considered prior to use.

ADVERSE EVENTS (APPLIES TO ALL SIZES)

Possible adverse effects include, but are not limited to, the following:

  • Acute myocardial infarction
  • Arrhythmias, including ventricular fibrillation
  • Arteriovenous fistula
  • Coronary artery spasm
  • Coronary vessel dissection, perforation, rupture, or injury
  • Death
  • Drug reactions, allergic reaction to contrast medium
  • Embolism
  • Hemorrhage or hematoma
  • Hypo / hypertension
  • Infection
  • Restenosis of the dilated vessel
  • Total occlusion of the coronary artery or bypass graft
  • Unstable angina

RxThe XIENCE V®, XIENCE nano®, XIENCE PRIME®, XIENCE PRIME® LL, XIENCE Xpedition®, XIENCE Xpedition® SV and XIENCE Xpedition® LL , XIENCE Alpine®, and XIENCE SierraTM (XIENCE Family) of Everolimus Eluting Coronary Stents on the MULTI-LINK VISION® or MULTI-LINK MINI VISION® Delivery System

INDICATIONS

The XIENCE Sierra stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. In addition, the XIENCE Sierra stent system is indicated for treating de novo chronic total coronary occlusions.

CONTRAINDICATIONS

The XIENCE Sierra stent system is contraindicated for use in:

  • Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or the post-procedural antiplatelet regimen.
  • Patients with hypersensitivity or contraindication to everolimus or structurally related compounds, or known hypersensitivity to stent components (cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers), or with contrast sensitivity.

WARNINGS
 

  • It is not recommended to treat patients having a lesion that prevent complete inflation of an angioplasty balloon.
  • Judicious patient selection is necessary because the use of this device carries the associated risk of stent thrombosis, vascular complications, and/or bleeding events.
  • This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.

PRECAUTIONS
 

  • Ensure that the inner package sterile barrier has not been opened or damaged prior to use.
  • Stent implantation should only be performed by physicians who have received appropriate training.
  • Stent placement should be performed at hospitals where emergency coronary artery bypass graft surgery (CABG) is accessible.
  • Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. Long-term outcomes following repeat dilatation of the stent are presently unknown.
  • Care should be taken to control the guiding catheter tip during stent delivery, deployment and balloon withdrawal. Before withdrawing the stent delivery system, visually confirm complete balloon deflation by fluoroscopy to avoid guiding catheter movement into the vessel and subsequent arterial damage.
  • When DES are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the SPIRIT family of trials.
  • Compared to use within the specified Indications for Use, the use of DES in patients and lesions outside of the labeled indications may have an increased risk of adverse events, including stent thrombosis, stent embolization, MI, or death.
  • Orally administered everolimus combined with cyclosporine is associated with increased serum cholesterol and triglycerides levels.
  • A patient’s exposure to drug and polymer is proportional to the number and total length of implanted stents. See Instructions for Use for current data on multiple stent implantation.
  • Safety and effectiveness of the XIENCE Family of stents have not been established for subject populations with the following clinical settings:
    • Patients with prior brachytherapy of the target lesion or the use of brachytherapy for treated site restenosis, patients in whom mechanical atherectomy devices or laser angioplasty catheters are used in conjunction with XIENCE Family stents, women who are pregnant or lactating, men intending to father children, pediatric patients, unresolved vessel thrombus at the lesion site, coronary artery reference vessel diameters < 2.25 mm or > 4.25 mm or lesion length > 32 mm, lesions located in saphenous vein grafts, unprotected left main coronary artery, ostial lesions, lesions located at a bifurcation or previously stented lesions, diffuse disease or poor flow (TIMI < 1) distal to the identified lesions, excessive tortuosity proximal to or within the lesion, recent Acute Myocardial Infarction (AMI) or evidence of thrombus in target vessel, multivessel disease, and in-stent restenosis.
  • Everolimus has been shown to reduce the clearance of some prescription medications when administered orally along with cyclosporine (CsA). Formal drug interaction studies have not been performed with the XIENCE Family of stents because of limited systemic exposure to everolimus eluted from the stent.
  • Everolimus is an immunosuppressive agent. Consideration should be given to patients taking other immunosuppressive agents or who are at risk for immune suppression.
  • Oral everolimus use in renal transplant patients and advanced renal cell carcinoma patients was associated with increased serum cholesterol and triglycerides, which in some cases required treatment.
  • Non-clinical testing has demonstrated that the XIENCE Sierra stent, in single and in overlapped configurations up to 71 mm in length, is MR Conditional. It can be scanned safely under the conditions in the Instructions for Use.
  • The XIENCE Family of stents should be handled, placed, implanted, and removed according to the Instructions for Use.

POTENTIAL ADVERSE EVENTS

Adverse events (in alphabetical order) which may be associated with percutaneous coronary intervention treatment procedures and the use of a coronary stent in native coronary arteries include, but are not limited to, the following:

  • Abrupt closure, hematoma, or hemorrhage, Acute myocardial infarction, Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, device materials (platinum, polymer, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers), and drug reactions to everolimus, anticoagulation, or antiplatelet drugs, Arterial rupture, Arteriovenous fistula, Arrhythmias, atrial and ventricular, Bleeding complications, which may require transfusion, Cardiac tamponade, Coronary artery spasm, Coronary or stent embolism, Coronary or stent thrombosis, Death, Dissection of the coronary artery, Fever, Hypotension and/or hypertension, Ischemia (myocardial), Myocardial infarction (MI), Nausea and vomiting, Palpitations, Peripheral ischemia, Pseudoaneurysm, Renal Failure, Restenosis, Shock/pulmonary edema, Stroke/cerebrovascular accident (CVA), Total occlusion of coronary artery, Unstable or stable angina pectoris, Vascular access complications which may require vessel repair, Vessel dissection

The risks described below include, but are not limited to, the anticipated adverse events relevant for the cardiac population referenced in the contraindications, warnings, and precautions sections of the everolimus labels.

  • Abdominal pain; Anemia; Angioedema; Constipation; Cough; Diarrhea; Dyslipidemia (including hyperlipidemia and hypercholesterolemia); Dyspnea; Edema (peripheral); Headache; Hyperglycemia; Hypertension; Hypokalemia; Elevations of serum creatinine; Infections: bacterial, viral, fungal, and protozoan infections (may include opportunistic infections); Lymphoma and skin cancer; Male infertility; Oral ulcerations; Nausea; Non-infectious pneumonitis; Pain; Proteinuria; Pyrexia; Rash; Thrombotic microangiopathy (TMA)/Thrombotic thrombocytopenic purpura (TTP)/Hemolytic uremic syndrome (HUS); Urinary tract infection; Upper respiratory tract infection; Vomiting
  • Live vaccines should be avoided and close contact with those that have had live vaccines should be avoided. Fetal harm can occur when administered to a pregnant woman. There may be other potential adverse events that are unforeseen at this time.
  • AP2945901-WBU Rev. A

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