ABBOTT PARK, Ill., May 23, 2018
/PRNewswire/ -- Abbott (NYSE: ABT) today announced it received
approval from the U.S. Food and Drug Administration (FDA) for
XIENCE SierraTM, the newest generation of the company's
gold-standard XIENCE everolimus-eluting coronary stent system.
XIENCE stents are among the world's most-used and studied stents
and have an exceptional safety record with low rates of
complications. Design and technology advances in this generation of
XIENCE include features specifically designed for the treatment of
complex blockages that now account for up to 70 percent of
cases.1
"We developed XIENCE Sierra so that physicians can more easily
deliver the stent even in challenging cases," said Chuck Brynelsen, senior vice president of
Abbott's vascular business. "The updated design and improved
deliverability mean doctors can access and unblock
difficult-to-treat lesions with more flexibility and precision than
other stents."
Design innovations in XIENCE Sierra include a thinner profile,
increased flexibility, longer lengths, and small diameters. The new
stent and delivery system were specifically developed for the
treatment of complex cases, including people with multiple or
totally blocked vessels.
More than 8 million people worldwide have received a XIENCE
stent since its initial regulatory approvals in the EU in 2006 and
in the U.S. in 2008. Its unparalleled safety is supported in over
100 clinical trials and by 10 years of global real-world
experience.2
Abbott received Regulatory approval for XIENCE Sierra in
Japan in April 2018, and CE Mark in Europe in October
2017.
About Coronary Artery Disease:
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 FDA approval in 2008. Its safety profile is unparalleled with
consistent low rates of stent thrombosis, even in complex
cases.3,4 A special coating on XIENCE interacts with
proteins in the blood to reduce the risk for blood clots in the
stent. The XIENCE Sierra stent is implanted using a catheter that
is inserted through the femoral artery in the groin or radial
artery in the wrist. For more information about XIENCE, visit
www.XienceStent.com/US
For U.S. Important Safety Information, visit:
https://www.vascular.abbott/us/products/coronary-intervention/xience-sierra.html#prodisi
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, 99,000
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 Decision Resources Group, July 2017. Data on file at Abbott.
2 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.
3 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.
4 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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SOURCE Abbott