- XIENCE Sierra™, the newest generation of drug-eluting XIENCE stent receives CE Mark, representing European approval
- New stent design, new delivery system, and unique sizes improve doctors' ability to access and unblock clogged arteries in complicated cases
- Efficacy and exceptional safety of XIENCE supported by 10 years of real-world experience and more than 100 clinical trials
ABBOTT PARK, Ill., Oct. 30, 2017 /PRNewswire/ -- Abbott (ABT) today announced it received CE Mark for XIENCE Sierra, the newest generation of the company's gold-standard XIENCE everolimus-eluting coronary stent system. CE Mark allows sale of the device in the European Union and other countries that recognize CE Mark. Advances in this generation of XIENCE — which is known for its exceptional safety — include new features that make it easier for cardiologists to successfully complete complex procedures that now account for up to 70 percent of cases.2
"Doctors tell us they need better tools to treat increasingly challenging cases, which involve multiple, or totally blocked arteries and complications such as diabetes," said Chuck Brynelsen, senior vice president of Abbott's vascular business. "We designed XIENCE Sierra with the goal of helping more people with coronary artery disease regain their health and return to their daily lives as quickly as possible."
XIENCE Sierra makes it easier for cardiologists to access and unblock difficult-to-reach lesions. New features include a thinner profile, increased flexibility, longer lengths, and small-diameters.
"XIENCE Sierra can help cardiologists be even more precise when implanting the stent, which is important for efficacy and safety," said Charles Simonton, M.D., chief medical officer of Abbott's vascular business. "Its design, range of sizes, and increased flexibility mean doctors don't have to use as much force when they implant a XIENCE Sierra stent compared to other stents."3
More than eight million people worldwide have received a XIENCE stent since its initial regulatory approval.4 It is the most commonly used stent in Europe and has been studied in over 100 clinical trials and in 10 years of global real-world experience.
Abbott has also submitted an application to the U.S. Food and Drug Administration for XIENCE Sierra approval in the United States.
About Coronary Artery Disease:
More than four million people die in Europe each year due to cardiovascular diseases, of which coronary artery disease is the most common type.5 Coronary artery disease occurs when the arteries that supply blood to the heart become hard and narrow, leading to chest pain or shortness of breath and increased risk of heart attack.
To treat coronary artery disease, interventional cardiologists may perform a percutaneous coronary intervention, a non-surgical procedure that uses a catheter inserted through an artery in the leg or wrist to implant a stent that reopens vessels and allow blood to flow.
XIENCE first received CE Mark in 2006 and has an unprecedented safety profile, with consistent low rates of stent thrombosis, even in complex cases.6,7 A special coating on XIENCE interacts with proteins in the blood to reduce the risk for blood clots in the stent. For more information about XIENCE, visit www.XienceStent.com.
For U.S. Important Safety Information visit: https://vascular.abbott.com/Xience-Stent-Safety.html#isi
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
1 EUCOMED and Decision Resources Group, September 2017
2 Decision Resources Group, July 2017. Data on file at Abbott.
3 Tests performed by and data on file at Abbott.
4 Data on file at Abbott.
5 2012 European Cardiovascular Disease Statistics, European Society of Cardiology https://www.escardio.org/The-ESC/What-we-do/Initiatives/EuroHeart/2012-European-Cardiovascular-Disease-Statistics. Accessed October 4, 2017; Page 1, Bullet 1
6 Palmerini, et al. XIENCE showed significant benefit compared to several DES and composite BMS in multiple large scale meta-analyses and other RCTs. 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, et al. 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.
7 XIENCE showed significant benefit compared to several DES and composite BMS in multiple large scale meta-analyses and other RCTs. 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
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