- 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, Illinois, Oct. 30,
2017 /PRNewswire/ -- Abbott (NYSE: 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.
About XIENCE:
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
About Abbott:
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.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
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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