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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.

 

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.

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.

UNIQUE DESIGN BEHIND XIENCE SAFETY DATA

All components of the XIENCE Alpine stent are designed for safety.

Stent DesignStent Design

  • Proven cobalt chromium (CoCr) MULTI-LINK design
  • Flexible stent and delivery system for conformability, less injury4
  • Low metal-to-artery ratio reduces injury, inflammation5
  • Thin well-apposable struts for rapid re-endothelialization, healing, and reduced thrombogenicity6, 7

Coating TechnologyCoating Technology

  • Fluorinated polymer
  • Coating durability, flexibility and elasticity for stent use
  • 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 defects11

Drug: EverolimusDrug Everolimus

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



*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.

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.

CLINICAL DATA POINT TO XIENCE ALPINE SAFETY

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The BMS comparator is a composite of several bare metal stents as a representation of the BMS category.

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.4
The Platinum Plus trial examined the
XIENCE and Promus Element stents.5

XIENCE data reveal lower stent thrombosis

Learn more about the XIENCE safety difference.

XIENCE’S LOW STENT THROMBOSIS: MULTIPLE TRIAL META-ANALYSIS

Results from various analyses reveal XIENCE’s efficacy and safety, particularly related to XIENCE's low definite stent thrombosis (ST) rates.

XIENCE: Safer Than a Biodegradable Polymer DES per Multiple RCT Network Meta-Analyses

XIENCE: lower stent thrombosis

 

*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.

**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. Serruys PW, et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010;363:136-146. doi: 10.1056/NEJMoa1004130.
5. Fajadet J. Platinum Plus. TCT 2012
6. An odds ratio is a method of comparing the odds of an event between two groups.
7. A rate ratio is a method of comparing the incidence of events between two groups.
8. Bangalore S, et al. BMJ. 2013;347:f6625. doi: 10.1136/bmj.f6625.
9. Palmerini T, et al. JACC. 2014;63:299-307. doi: 10.1016/j. jacc.2013.09.061

FLUOROPOLYMER COATING PROMOTES XIENCE ALPINE STENT SAFETY

THE FLUOROPOLYMER’S PROTECTIVE NATURE

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

How Fluoropassivation Leads to Thromboresistance

Fluoropolymer video image

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-DES13

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 stent, 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 Torii S, et al. Acute thrombogenicity and inflammation in response to a durable fluoropolymer everolimus-eluting stent relative to a durable BioLinx polymer zotarolimus-eluting stent. J Am Coll Cardiol. 2017;70(18):B201. 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. Szott LM, et al. Biointerphases. 2016;11:029806. doi: 10.1116/1.4944586.
5. Wertz CF, et al. Langmuir. 2001;17:3006-3016. doi: 10.1021/la0017781.
6. Panchalingam V, et al. ASAIO J. 1993;39:M305-M309.
7. Joner M, et al. J Am Coll Cardiol. 2008;52(5):333-432. doi: 10.1016/j.jacc.2008.04.030.
8. Perkins LEL, et al. J Interv Cardiol. 2009;22(s1):S28-S40.
9. Otsuka F, et al. Circ Cardiovasc Interv. 2014;7:330-342.
10. Garfinkle AM, et al. Trans Am Soc Artif Intern Organs. 1984;30:432-439.
11. Fluorinated surfaces have been used for cardiovascular implants to benefit from thromboresistance and long-term biocompatibility.
12. Ao PY, et al. Eur J Vasc Endovasc Surg. 2000;20:241-249. doi.org/10.1053/ejvs.2000.1177.
13. Otsuka F, et al. JACC Cardiovasc Interv. 2015;8:1248-1260. doi: 10.1016/j.jcin.2015.03.029.
14. Chinn JA, et al. J Biomed Mater Res. 1998;39:130-140. doi: 10.1002/(SICI)1097-4636(19980101)39:1<130::AID-JBM15>3.0.CO;2-J.


XIENCE ALPINE STENT DESIGN

XIENCE is the world's leading drug-eluting stent, with over 10 million implants.* 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.

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 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.


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 INDICATIONS AND INSTRUCTIONS FOR USE

The XIENCE Alpine everolimus-eluting Coronary Stent System is indicated for improving coronary luminal diameter in the following:

guide-wire-workhorse-int
  • Patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions
  • For restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset
  • For the treatment of:
    • Patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (two lesions in two different epicardial vessels), lesions residing within small coronary vessels
    • Lesions where treatment results in the jailing of side branches (lesions with a side branch < 2 mm in diameter or an ostial stenosis < 50%)
    • Elderly patients (age ≥ 65)
    • Both men and women
  • For the treatment of patients presenting with:
    • In-stent restenosis in coronary artery lesions
    • Chronic total occluded coronary artery lesions (defined as coronary artery lesions with TIMI flow 0 and lasting longer than 3 months)
    • Coronary artery bifurcation lesions

  • In all cases, the treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 15 mm, 18 mm, 23 mm, 28 mm, 33 mm, or 38 mm) with a reference vessel diameter of > 2.00 mm and < 4.25 mm.


    See the Instructions for Use.

    *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.


    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 RESOURCES

XienceStent.com Microsite

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.

 

 

*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.

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.

ORDERING XIENCE ALPINE

STENT DIAMETER STENT LENGTH
8 mm 12 mm 15 mm 18 mm
2.00 mm 1120200-08 1120200-12 1120200-15 1120200-18
2.25 mm 1120225-08 1120225-12 1120225-15 1120225-18
2.50 mm 1120250-08 1120250-12 1120250-15 1120250-18
2.75 mm 1120275-08 1120275-12 1120275-15 1120275-18
3.00 mm 1120300-08 1120300-12 1120300-15 1120300-18
3.25 mm 1120325-08 1120325-12 1120325-15 1120325-18
3.50 mm 1120350-08 1120350-12 1120350-15 1120350-18
4.00 mm 1120400-08 1120400-12 1120400-15 1120400-18
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ORDERING XIENCE ALPINE
STENT DIAMETER STENT LENGTH
23 mm 28 mm 33 mm 38 mm
2.00 mm 1120200-23 1120200-28 - -
2.25 mm 1120225-23 1120225-28 - -
2.50 mm 1120250-23 1120250-28 1120250-33 1120250-38
2.75 mm 1120275-23 1120275-28 1120275-33 1120275-38
3.00 mm 1120300-23 1120300-28 1120300-33 1120300-38
3.25 mm 1120325-23 1120325-28 1120325-33 1120325-38
3.50 mm 1120350-23 1120350-28 1120350-33 1120350-38
4.00 mm 1120400-23 1120400-28 1120400-33 1120400-38
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ORDERING XIENCE ALPINE

PRODUCT INFORMATION

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 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.

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.

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