XIENCE Alpine Everolimus Eluting Coronary Stent System
VASCULAR
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IMPLANTED MORE THAN ANY OTHER
DRUG-ELUTING STENT

XIENCE Alpine is part of the XIENCE family of drug-eluting stents (DES) and is designed for complex percutaneous coronary intervention (PCI). XIENCE, which slowly releases everolimus to inhibit restenosis, is widely recognized for its unparalleled safety.1-3 With more than 10 million stents implanted worldwide,* and studied in more than 100 clinical trials, XIENCE is the most studied and trusted drug-eluting stent on the market.

For more information about XIENCE, visit XienceStent.com/us.

 

THE FUNDAMENTALS BEHIND XIENCE ALPINE

The XIENCE Alpine coronary stent system may be used by interventional cardiologists to treat a blockage and open the artery. A stent implant procedure is known as percutaneous coronary intervention (PCI).

XIENCE, which is also described as a drug-eluting stent (DES) or more specifically an everolimus-eluting stent (EES), is a leading DES because of its considerable safety data. XIENCE Alpine is engineered for complex intervention.

Precision in Stent Placement
MULTI-LINK design, with 100% accurate mid-marker to mid-marker stent placement, offers precise deployment

True Center Tip
Flexible tip design with co-axial positioning system (CPS) offers peak performance in complex lesions

Higher Performance Catheter
Catheter is engineered to optimize strength, flexibility and pushability

  • Zero-transition distal shaft
  • Proprietary skive design
  • Robust hypotube with optimized thickness
  • Specially formulated outer member

Durable Balloon with Flat Compliance
Thin, dual-layer balloon enables high pressure deployment while maintaining flexibility and strength.

Stent DesignStent Design

  • Proven cobalt chromium (CoCr) MULTI-LINK design
  • Flexible stent and delivery system for conformability and less injury4
  • Low metal-to-artery ratio reduces injury, inflammation5
  • Thin well-apposable struts for rapid re-endothelialization, healing and reduced thrombogenicity6, 7
  • Reliable coating integrity due to no touch points and low strain stent design

Coating TechnologyCoating Technology

  • Fluorinated polymer8, 9
  • Coating durability, flexibility and elasticity for stent use9, 10
  • Known biocompatibility for cardiovascular
    implants8-11
  • Attracts albumin to surface for thromboresistance12
  • Minimal inflammation8-10
  • Fast and functional endothelialization8, 12, 13
  • Multi-layer application over a primer to minimize coating defects

Drug: EverolimusDrug Everolimus

  • Elution rate matched to restenosis cascade by optimal coating thickness8
  • Low drug dose11
  • Broad therapeutic range8, 11

U.S. PATIENT INFORMATION GUIDE

Cover of Patient Information Guide

Ensure that patients have the information they need about coronary artery disease and the XIENCE family of stent systems. The XIENCE Patient Information Guide illustrates the stent procedure and outlines the risks and benefits of treatment with XIENCE.


*10,000,000 implants number is based on data of DES implants through Q1 2017. Comparative claim based on unit usage in U.S., Japan, China, India, top 5 Western Europe and Korea. Other leading DES: BSX stents (Promus ElementTM, Promus ElementTM Plus, Promus PremierTM, SynergyTM); MDT stents (ResoluteTM, Resolute IntegrityTM, Resolute OnyxTM); Terumo stents (NoboriTM, Ultimaster®); Biotronik stent (OrsiroTM); and Biosensors stent (BioMatrixTM).


Data on file at Abbott

References

1. Valgimigli M. Effects of cobalt-chromium everolimus eluting or bare metal stent on fatal and non-fatal cardiovascular events: a patient-level meta analysis. EuroPCR 2014.
2. Bangalore S, et al. BMJ. 2013;347:f6625. doi: 10.1136/bmj.f6625.
3. Palmerini T, et al. JACC. 2014;63:299-307. doi: 10.1016/j.jacc.2013.09.061.
4. Colombo A, et al. JACC. 2002;40:1021-1033.
5. Data on file at Abbott Vascular.
6. Kolandaivelu K, et al. Circulation. 2011;123;1400-1409.
7. Kastrati A, et al. Circulation. 2001;103;2816-2821.
8. Perkins LEL, et al. J Interv Cardiol. 2009;22(s1):S28-S40.
9. Otsuka F, et al. JACC Cardiovasc Interv. 2015;8:1248-1260. doi: 10.1016/j.jcin.2015.03.029.
10. Otsuka F, et al. Circ Cardiovasc Interv. 2014;7:330-342.
11. Ding N, et al. J Interv Cardiol. 2009;22(s1):S18-S27.
12. Joner M, et al. J Am Coll Cardiol. 2008;52(5):333-432. doi: 10.1016/j.jacc.2008.04.030.
13. Guidoin R, et al. ASAIO J. 1994;40(3):M870-M879.

XIENCE ALPINE SAFETY

IMPLANTED MORE THAN ANY OTHER DRUG-ELUTING STENT

XIENCE, the world’s leading drug-eluting stent (DES), is widely considered by industry experts in the field of cardiology to be the gold standard in drug-eluting metallic stent therapy.

More than 10 million XIENCE implants

EVIDENCE OF LOW STENT THROMBOSIS

After receiving a DES, patients need to take blood thinners—to prevent blood clot formation (stent thrombosis) which could potentially lead to a heart attack.

One indicator of XIENCE safety is apparent in a meta-analysis, which examined data from 50,844 patients across 49 high-quality randomized controlled trials. The meta-analysis compared the safety between XIENCE and other drug-eluting stents, as well as between XIENCE and bare metal stents.

The results are illustrated below, with all of the findings confirming statistically significant lower rates of stent thrombosis with the XIENCE everolimus-eluting stent.

XIENCE: Significantly Lower Definite Stent Thrombosis in Large-Scale Meta-Analyses4, 5

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Note: As with any meta-analysis, the underlying studies may have differences in design, enrollment criteria and endpoints; the meta-analysis results would share the same limitations as the original underlying studies.

Learn more about the XIENCE safety difference.

IN-STENT THROMBOSIS RATES: XIENCE VS. OTHER DES

Compared to other drug-eluting stents (DES), XIENCE—with stent thrombosis (ST) rates of 0.0% and 0.1%—outperforms these other DES at 30 days:


The Resolute All Comers trial was designed to be representative of everyday clinical practice.6 The Platinum Plus trial examined the
XIENCE and Promus Element stents.7

XIENCE data reveal lower stent thrombosis

 

MORE DATA ON XIENCE SAFETY

In a meta-analysis of all-comer complex patients that compared XIENCE everolimus-eluting stent to bare metal stents (BMS),** XIENCE was shown to save lives and help reduce heart attack risk.

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*10,000,000 implants number is based on data of DES implants through Q1 2017. Comparative claim based on unit usage in U.S., Japan, China, India, top 5 Western Europe and Korea. Other leading DES: BSX stents (Promus ElementTM, Promus ElementTM Plus, Promus PremierTM, SynergyTM); MDT stents (ResoluteTM, Resolute IntegrityTM, Resolute OnyxTM); Terumo stents (NoboriTM, Ultimaster®); Biotronik stent (OrsiroTM); and Biosensors stent (BioMatrixTM). Data on file at Abbott Vascular.
**The BMS comparator is a composite of several bare metal stents as a representation of the BMS category.
†An odds ratio is a method of comparing the odds of an event between two groups.


References

1. Valgimigli M. Effects of cobalt-chromium everolimus eluting or bare metal stent on fatal and non-fatal cardiovascular events: a patient-level meta-analysis. EuroPCR 2014.
2. Bangalore S, et al. BMJ. 2013;347:f6625. doi: 10.1136/bmj.f6625.
3. Palmerini T, et al. JACC. 2014;63:299-307. doi: 10.1016/j.jacc.2013.09.061.
4. Palmerini T, et al. Meta-Analysis. The Lancet. 2012;379:1393-1402. doi: http://dx.doi.org/10.1016/S0140-6736(12)60324-9.
5. "Meta-analyses should be regarded as hypothesis-generating and the findings of Palmerini and colleagues suggest that a randomized trial of CoCr EES and BMS is desirable." Ormiston JA, et al. The Lancet. 2012;379:1368-1369. doi: 10.1016/S0140-6736(12)60440-1.
The XIENCE system’s clinical outcomes result from its components, including: a thin-strut, flexible ring and link design, with favorable strut apposition, no metal-to-metal touch points, and low strain upon expansion; the novel everolimus compound; and the multi-layer coating and primer technologies, using a fluorinated polymer class known for cardiovascular implants, and known for having excellent mechanical properties.
6. Serruys PW, et al. Resolute All Comers Trial. N Engl J Med. 2010;363:136-146. doi: 10.1056/NEJMoa1004130.
7. Fajadet J. Platinum Plus. TCT 2012.

FLUOROPOLYMER COATING PROMOTES XIENCE ALPINE STENT SAFETY

THE FLUOROPOLYMER’S PROTECTIVE NATURE

The XIENCE fluoropolymer coating, unlike other polymers, interacts with blood proteins to reduce thrombus formation (through thromboresistance) in a process termed fluoropassivation.

How Fluoropassivation Leads to Thromboresistance

THE TYPE OF STENT POLYMER MATTERS

Analyses reveal that XIENCE demonstrates the most thromboresistance when compared with several other types of bioabsorbable polymer drug-eluting stents.

Least Thrombus Area with XIENCE vs. BP-DES4

Fewest thrombus areas on XIENCE vs three other stents

Green areas are platelets
Ex vivo porcine photomicrographs reveal the least thrombosis area on XIENCE

 

DATA SHOW LESS THROMBUS FORMATION WITH
XIENCE ALPINE

In addition, XIENCE Alpine has been shown to be less thrombogenic compared to the Resolute Onyx stent5, which employs a different polymer.** Red areas indicate thrombus formation.


Alpine: no thrombus areas vs Resolute Onyx

Ex vivo porcine arteriovenous shunt model**

 

Find out more about the unique XIENCE fluoropolymer and its protective characteristics.



*10,000,000 implants number is based on data of DES implants through Q1 2017. Comparative claim based on unit usage in U.S., Japan, China, India, top 5 Western Europe and Korea. Other leading DES: BSX stents (Promus Element™, Promus Element™ Plus, Promus Premier™, Synergy™); MDT stents (Resolute™, Resolute Integrity™, Resolute Onyx™); Terumo stents (Nobori™, Ultimaster®); Biotronik stent (Orsiro™); and Biosensors stent (BioMatrix™). Data on file at Abbott Vascular.

** Representative confocal photomicrographs showing least platelets (CD42b/CD61, red) on XIENCE as compared to Onyx. Ex vivo porcine arteriovenous shunt model; methods published by Otsuka F, et al. JACC Cardiovasc Interv. 2015;8:1248-1260. Data presented as mean ± SD. Preliminary data. Data on file with Abbott Vascular.

References

1. Valgimigli M. Effects of cobalt-chromium everolimus eluting or bare metal stent on fatal and non-fatal cardiovascular events: a patient-level meta-analysis. EuroPCR 2014.
2. Bangalore S, et al. BMJ. 2013;347:f6625. doi: 10.1136/bmj.f6625.
3. Palmerini T, et al. JACC. 2014;63:299-307. doi: 10.1016/j.jacc.2013.09.061.
4. Otsuka F, et al. JACC Cardiovasc Interv. 2015;8:1248-1260. doi: 10.1016/j.jcin.2015.03.029.
5. Torii, S., Kolodgie, F., Cheng, Q., Acampado, E., Mori, H., Perkins, L., Hossainy, S., Pacetti, S., Finn, A.V. and Virmani, R. (2017). Acute Thrombogenicity and Inflammation in Response to a Durable Fluoropolymer Everolimus-Eluting Stent Relative to a Durable BioLinx polymer Zotarolimus-Eluting Stent. Journal of the American College of Cardiology 70, B201.

XIENCE ALPINE STENT DESIGN

XIENCE is the world's leading drug-eluting stent. Its success is due to interventional cardiologists’ ability to effectively treat a broad range of patients—from simple to complex lesions, and from lower risk individuals to higher risk patients like those with diabetes or chronic total occlusion.

The XIENCE stent’s quality and performance are attributable to these features:

  • It has a flexible and conformable design based on the proven MULTI-LINK design platform
  • There is no touching or overlapping of struts when crimped
  • There is minimal stent shortening when deployed
  • It uses a catheter optimized for strength, flexibility and pushability
  • It is engineered for complex cases
  • It has excellent apposition and complete expansion4, 5
  • It is manufactured from L-605 cobalt chromium (CoCr) alloy
  • It is an everolimus-eluting stent (EES)

XIENCE treating a blocked artery

Find out more about the XIENCE stent design.

STENT SPECIFICATIONS

Stent Design MULTI-LINK, 3-3-3, nonlinear link  
Stent Material L-605 Cobalt Chromium  
Drug Everolimus  
Polymer Fluorinated Copolymer  
Strut Thickness 0.0032"  
Maximum Expansion Diameter Size (mm)
2.25 -2.50
2.75 - 3.25
3.50 - 4.00
Maximum Exp. (mm)
3.25
3.75
4.50
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STENT SPECIFICATIONS

STENT DELIVERY SYSTEM SPECIFICATIONS

Working Catheter Length 145 cm    
GW Notch Width, Average 0.033"    
Nominal Pressure 10 atm    
Rated Burst Pressure 18 atm    
Balloon Material Multilayer Pebax    
Crossing Profile 0.0425" (3.0 x 18 mm)    
Tip Entry Profile 0.017"    
Kissing Stent Compatibility 6F (0.070")    
Shaft Measurements Proximal
0.028"
Mid-Shaft
0.035"
Distal
0.033"
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STENT DELIVERY SYSTEM SPECIFICATIONS


*10,000,000 implants number is based on data of DES implants through Q1 2017. Comparative claim based on unit usage in U.S., Japan, China, India, top 5 Western Europe and Korea. Other leading DES: BSX stents (Promus ElementTM, Promus ElementTM Plus, Promus PremierTM, SynergyTM); MDT stents (ResoluteTM, Resolute IntegrityTM, Resolute OnyxTM); Terumo stents (NoboriTM, Ultimaster®); Biotronik stent (OrsiroTM); and Biosensors stent (BioMatrixTM). Data on file at Abbott Vascular.



References
1. Valgimigli M. Effects of cobalt-chromium everolimus eluting or bare metal stent on fatal and non-fatal cardiovascular events: a patient-level meta-analysis. EuroPCR 2014.
2. Bangalore S, et al. BMJ. 2013;347:f6625. doi: 10.1136/bmj.f6625.
3. Palmerini T, et al. JACC. 2014;63:299-307. doi: 10.1016/j.jacc.2013.09.061.
4. Kolandaivelu K, et al. Circulation. 2011;123:1400-1409. doi: doi.org/10.1161/CIRCULATIONAHA.110.003210.
5. Kim B-K, et al. Yonsei Med J. 2012;53:524-529. doi: doi.org/10.3349/ymj.2012.53.3.524.



XIENCE ALPINE RESOURCES

XienceStent.com Microsite (U.S. physicians)

this is Xience safety

Access the latest information on the world's leading drug-eluting stent (DES) and its safety in complex patient populations, including physician perspectives, helpful FAQs and status of featured trials.

View Website Now

U.S. Patient Information Guide

Cover of Patient Information Guide

Ensure that patients have the information they need about coronary artery disease and the XIENCE family of stent systems. The XIENCE Patient Information Guide illustrates the stent procedure and outlines the risks and benefits of treatment with XIENCE.


 





*10,000,000 implants number is based on data of DES implants through Q1 2017. Comparative claim based on unit usage in U.S., Japan, China, India, top 5 Western Europe and Korea. Other leading DES: BSX stents (Promus ElementTM, Promus ElementTM Plus, Promus PremierTM, SynergyTM); MDT stents (ResoluteTM, Resolute IntegrityTM, Resolute OnyxTM); Terumo stents (NoboriTM, Ultimaster®); Biotronik stent (OrsiroTM); and Biosensors stent (BioMatrixTM). Data on file at Abbott Vascular.

 

References

1. Valgimigli M. Effects of cobalt-chromium everolimus eluting or bare metal stent on fatal and non-fatal cardiovascular events: a patient-level meta-analysis. EuroPCR 2014.
2. Bangalore S, et al. BMJ. 2013;347:f6625. doi: 10.1136/bmj.f6625.
3. Palmerini T, et al. JACC. 2014;63:299-307. doi: 10.1016/j.jacc.2013.09.061.

XIENCE ALPINE RAPID EXCHANGE SIZE MATRIX

STENT DIAMETER STENT LENGTH
8 mm 12 mm 15 mm 18 mm
2.25 mm 1125225-08 1125225-12 1125225-15 1125225-18
2.50 mm 1125250-08 1125250-12 1125250-15 1125250-18
2.75 mm 1125275-08 1125275-12 1125275-15 1125275-18
3.00 mm 1125300-08 1125300-12 1125300-15 1125300-18
3.25 mm 1125325-08 1125325-12 1125325-15 1125325-18
3.50 mm 1125350-08 1125350-12 1125350-15 1125350-18
4.00 mm 1125400-08 1125400-12 1125400-15 1125400-18
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STENT DIAMETER STENT LENGTH
23 mm 28 mm 33 mm 38 mm
2.25 mm 1125225-23 1125225-28 - -
2.50 mm 1125250-23 1125250-28 1125250-33 1125250-38
2.75 mm 1125275-23 1125275-28 1125275-33 1125275-38
3.00 mm 1125300-23 1125300-28 1125300-33 1125300-38
3.25 mm 1125325-23 1125325-28 1125325-33 1125325-38
3.50 mm 1125350-23 1125350-28 1125350-33 1125350-38
4.00 mm 1125400-23 1125400-28 1125400-33 1125400-38
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XIENCE ALPINE OVER THE WIRE SIZE MATRIX

STENT DIAMETER STENT LENGTH
8 mm 12 mm 15 mm 18 mm
2.25 mm 1145225-08 1145225-12 1145225-15 1145225-18
2.50 mm 1145250-08 1145250-12 1145250-15 1145250-18
2.75 mm 1145275-08 1145275-12 1145275-15 1145275-18
3.00 mm 1145300-08 1145300-12 1145300-15 1145300-18
3.25 mm 1145325-08 1145325-12 1145325-15 1145325-18
3.50 mm 1145350-08 1145350-12 1145350-15 1145350-18
4.00 mm 1145400-08 1145400-12 1145400-15 1145400-18
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STENT DIAMETER STENT LENGTH
23 mm 28 mm 33 mm 38 mm
2.25 mm 1145225-23 1145225-28 - -
2.50 mm 1145250-23 1145250-28 1145250-33 1145250-38
2.75 mm 1145275-23 1145275-28 1145275-33 1145275-38
3.00 mm 1145300-23 1145300-28 1145300-33 1145300-38
3.25 mm 1145325-23 1145325-28 1145325-33 1145325-38
3.50 mm 1145350-23 1145350-28 1145350-33 1145350-38
4.00 mm 1145400-23 1145400-28 1145400-33 1145400-38
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PRODUCT INFO

Our online product catalogs provide the very latest information available, right at your fingertips. Download catalogs by product family in PDF format, or view the entire Abbott Vascular inventory in Excel. Product barcodes enable direct scanning for easy reordering.

 

View Product Catalogs



*10,000,000 implants number is based on data of DES implants through Q1 2017. Comparative claim based on unit usage in U.S., Japan, China, India, top 5 Western Europe and Korea. Other leading DES: BSX stents (Promus ElementTM, Promus ElementTM Plus, Promus PremierTM, SynergyTM); MDT stents (ResoluteTM, Resolute IntegrityTM, Resolute OnyxTM); Terumo stents (NoboriTM, Ultimaster®); Biotronik stent (OrsiroTM); and Biosensors stent (BioMatrixTM). Data on file at Abbott Vascular.

 

References

1. Valgimigli M. Effects of cobalt-chromium everolimus eluting or bare metal stent on fatal and non-fatal cardiovascular events: a patient-level meta-analysis. EuroPCR 2014.
2. Bangalore S, et al. BMJ. 2013;347:f6625. doi: 10.1136/bmj.f6625.
3. Palmerini T, et al. JACC. 2014;63:299-307. doi: 10.1016/j.jacc.2013.09.061.

PRODUCT INFO

Our online product catalogs provide the very latest information available, right at your fingertips. Download catalogs by product family in PDF format, or view the entire Abbott Vascular inventory in Excel. Product barcodes enable direct scanning for easy reordering .

U.S. PATIENT INFORMATION GUIDE

Ensure that patients have information about coronary artery disease and the XIENCE family of stent systems. The XIENCE Patient Information Guide illustrates the stent procedure and outlines the risks and benefits of treatment with XIENCE.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

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

INDICATIONS

The XIENCE Family of Everolimus Eluting Coronary Stent Systems are indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions for XIENCE V (length ≤ 28 mm), XIENCE PRIME, XIENCE Xpedition and XIENCE Alpine (lengths ≤ 32 mm) with reference vessel diameters of ≥2.25 mm to ≤ 4.25 mm. Additionally, the entire XIENCE Family is indicated for treating de novo chronic total coronary occlusions.

CONTRAINDICATIONS

The XIENCE Family of stents is contraindicated for use in patients:

  • Who cannot receive antiplatelet and/or anti-coagulant therapy
  • With lesions that prevent complete angioplasty balloon inflation or proper placement of the stent or stent delivery system
  • With hypersensitivity or contraindication to everolimus or structurally-related compounds, cobalt, chromium, nickel, tungsten, acrylic, and/or fluoropolymers.

WARNINGS
 

  • Ensure that the inner package sterile barrier has not been opened or damaged prior to use.
  • 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
 

  • 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 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.
  • Risks and benefits should be considered in patients with severe contrast agent allergies.
  • 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.
  • Stent thrombosis is a low-frequency event that is frequently associated with myocardial infarction (MI) or death.
  • 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 target lesion or in-stent restenosis related brachytherapy, 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.
  • Nonclinical testing has demonstrated that the XIENCE Family of stents, in single and in overlapped configurations are MR conditional up to 68 mm in length for XIENCE V and XIENCE nano only and up to 71 mm in length for all other XIENCE Family stents. 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 and treatment procedure including coronary stent use in native coronary arteries include, but are not limited to:

  • Abrupt closure, Access site pain, hematoma, or hemorrhage, Acute myocardial infarction, Allergic reaction or hypersensitivity to contrast agent or cobalt, chromium, nickel, tungsten, acrylic and fluoropolymers; and drug reactions to antiplatelet drugs or contrast agent, Aneurysm, Arterial perforation and injury to the coronary artery, 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, Distal emboli (air, tissue or thrombotic), Emergent or non-emergent coronary surgery, Fever, Hypotension and / or hypertension, Infection and pain at insertion site, Injury to the coronary artery, Ischemia (myocardial), Myocardial infarction (MI), Nausea and vomiting, Palpitations, Peripheral ischemia (due to vascular injury), Pseudoaneurysm, Renal Failure, Restenosis of the stented segment of the artery, Shock/pulmonary edema, Stroke / cerebrovascular accident (CVA), Total occlusion of coronary artery, Unstable or stable angina pectoris, Vascular complications including at the entry site which may require vessel repair, Vessel dissection

Adverse events associated with daily oral administration of everolimus to organ transplant patients include but are not limited to:

  • Abdominal pain (including upper abdominal pain); Anemia; Angioedema; Anorexia; Asthenia; Constipation; Cough; Delayed wound healing/fluid accumulation; Diarrhea; Dyslipidemia (including hyperlipidemia and hypercholesterolemia); Dyspnea; Dysgeusia; Dyspepsia; Dysuria; Dry skin; Edema (peripheral); Epistaxis; Fatigue; Headache; Hematuria; Hyperglycemia (may include new onset of diabetes); Hyperlipidemia; Hyperkalemia; Hypertension; Hypokalemia; Hypomagnesemia; Hypophosphatemia; Increased serum creatinine; Infections and serious infections: bacterial, viral, fungal, and protozoal infections (may include herpes virus infection, polyoma virus infection which may be associated with BK virus associated nephropathy, and/or other opportunistic infections); Insomnia; Interaction with strong inhibitors and inducers of CY3PA4 or PgP; Leukopenia; Lymphoma and other malignancies (including skin cancer); Male infertility (azospermia and/or oligospermia); Mucosal inflammation (including oral ulceration and oral mucositis); Nausea; Neutropenia; Non-infectious pneumonitis; Pain: extremity, incision site and procedural, back, chest, and musculoskeletal; Proteinuria; Pruritus; Pyrexia; Rash; Stomatitis; Thrombocytopenia; Thrombotic microangiopathy (TMA)/Thrombotic thrombocytopenic purpura (TTP)/ Hemolytic uremic syndrome (HUS); Tremor; 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.
  • Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available) or at www.abbottvascular.com/ifu for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

    AP2932900-WBU Rev. E

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