MARLBOROUGH, Mass.,
Oct. 5, 2015 /PRNewswire/
-- Boston Scientific (NYSE: BSX) has received U.S. Food and
Drug Administration (FDA) approval for the SYNERGY™ Bioabsorbable
Polymer Drug-Eluting Stent System (BP-DES) for the treatment of
coronary artery disease.
With this FDA approval, Boston Scientific will commence
commercialization of the first and only BP-DES in the U.S. Notably,
both the drug coating and the polymer – which modulates drug
release – are fully absorbed shortly after drug elution is complete
at three months.
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The SYNERGY Stent provides synchronized drug and polymer
absorption. It is designed to enable more rapid and complete
arterial healing, and to thereby reduce the risk of complications
associated with long-term polymer exposure compared to
currently-used drug-eluting stents (DES) with permanent
polymers.
Existing DES devices reduce coronary restenosis, but the polymer
remains on the stent after the drug is delivered. Long-term
exposure to the polymer may cause inflammation, which delays
healing and has been associated with complications, including
neoatherosclerosis and stent thrombosis. The SYNERGY Stent is
designed for faster and sustained healing by eliminating long term
polymer exposure.
"Data from the EVOLVE II trial, which included the most complex
patient population studied in a U.S. regulatory approval stent
trial, demonstrated exceptional performance and safety of the
SYNERGY Stent," said Dean Kereiakes,
M.D., principal investigator of the EVOLVE II trial and medical
director at The Christ Hospital Heart & Vascular Center/The
Lindner Research Center, Cincinnati. "The U.S. cardiology community
will have access to a bioabsorbable polymer DES which will provide
excellent clinical outcomes and should optimize vessel
healing."
Results previously reported from EVOLVE II, a global,
multi-center, randomized, single-blind, non-inferiority pivotal
trial demonstrated 0% definite stent thrombosis (ST) after 24
hours. Four-year EVOLVE trial data demonstrated a continued 0%
stent thrombosis rate and a very low target lesion
revascularization (TLR) rate of 1.1%.
Boston Scientific will continue to advance the robust clinical
program supporting the SYNERGY Stent with the initiation of the
EVOLVE Short Dual Anti-Platelet Therapy (DAPT) Study, expected
during the first quarter of 2016. The company has received an
Investigational Device Exemption (IDE) for this prospective study
designed to assess the safety of three-month use of DAPT in
patients at high risk for bleeding undergoing percutaneous coronary
intervention (PCI) with the SYNERGY Stent.
"The introduction of the first bioabsorbable polymer stent in
the U.S. is a tremendous milestone in the evolution of stent
technology," said Kevin Ballinger,
president, Interventional Cardiology, Boston Scientific. "The
SYNERGY Stent is a next generation therapy designed to improve
patient outcomes and ultimately reduce health care costs associated
with the treatment of coronary artery disease."
About the SYNERGY Bioabsorbable Polymer Stent
The
SYNERGY Stent is the only bioabsorbable polymer stent available to
patients in the U.S. It features ultrathin stent struts with an
abluminal bioabsorbable drug/polymer coating technology that is
absorbed shortly after drug elution is complete at three months,
thereby eliminating long-term polymer exposure. Obtain more
information on the SYNERGY Clinical Program and Research in the
U.S. Information is also available for those outside the U.S.
The SYNERGY Stent received CE Mark in 2012. View or download an
image of the SYNERGY Stent.
About Boston Scientific
Boston Scientific transforms
lives through innovative medical solutions that improve the health
of patients around the world. As a global medical technology
leader for more than 35 years, we advance science for life by
providing a broad range of high performance solutions that address
unmet patient needs and reduce the cost of healthcare. For
more information, visit www.bostonscientific.com and connect on
Twitter and Facebook.
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CONTACTS
Media:
Trish Backes
Boston Scientific Corporation
(651) 582-5887 (office)
trish.backes@bsci.com
Investors:
Susie Lisa,
CFA
Boston Scientific Corporation
(508) 683-5565 (office)
investor_relations@bsci.com
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SOURCE Boston Scientific