Стент система коронарная xience alpine выделяющая лекарственный препарат эверолимус everolimus

XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

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 Design

Proven cobalt chromium (CoCr) MULTI-LINK design
Flexible stent and delivery system for conformability and less injury 4
Low metal-to-artery ratio reduces injury, inflammation 5
Thin well-apposable struts for rapid re-endothelialization, healing and reduced thrombogenicity 6, 7
Reliable coating integrity due to no touch points and low strain stent design

Coating Technology

Fluorinated polymer 8, 9
Coating durability, flexibility and elasticity for stent use 9, 10
Known biocompatibility for cardiovascular
implants 8-11
Attracts albumin to surface for thromboresistance 12
Minimal inflammation 8-10
Fast and functional endothelialization 8, 12, 13
Multi-layer application over a primer to minimize coating defects

Drug: Everolimus

Elution rate matched to restenosis cascade by optimal coating thickness 8
Low drug dose 11
Broad therapeutic range 8, 11

U.S. 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.

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.

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-Analyses 4, 5

_{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.}

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

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.

*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 TM , Promus Element TM Plus, Promus Premier TM , Synergy TM ); MDT stents (Resolute TM , Resolute Integrity TM , Resolute Onyx TM ); Terumo stents (Nobori TM , Ultimaster ® ); Biotronik stent (Orsiro TM ); and Biosensors stent (BioMatrix TM ). 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-DES 4

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 5 , which employs a different polymer.** Red areas indicate thrombus formation.

Ex vivo porcine arteriovenous shunt model**

*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

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 expansion 4, 5
It is manufactured from L-605 cobalt chromium (CoCr) alloy
It is an everolimus-eluting stent (EES)

Find out more about the XIENCE stent design.

Источник

Стент система коронарная xience alpine выделяющая лекарственный препарат эверолимус everolimus

Коронарная стент-система XIENCE Alpine