First Patient Enrolled in the Boston Scientific Multicenter Study of the
SYNERGY™ Coronary Stent System Featuring a Bioabsorbable Polymer Coating
NATICK, Mass., Nov. 30, 2012
NATICK, Mass., Nov. 30, 2012 /PRNewswire/ -- The first patient has been
enrolled in the Boston Scientific Corporation (NYSE: BSX) EVOLVE II clinical
trial, which is designed to further assess the safety and effectiveness of the
SYNERGY ^ Stent System and support U.S. Food and Drug Administration and
Japanese regulatory approvals for the treatment of atherosclerotic coronary
lesions. Boston Scientific received CE Mark approval for the SYNERGY Stent
System last month. The EVOLVE II clinical program is anticipated to enroll
approximately two thousand patients at up to 160 sites worldwide including the
United States, Canada, Europe, Australia, New Zealand, Japan, India, Brazil
and Singapore. The first patient was enrolled at the Christ Hospital, Lindner
Research Center in Cincinnati, Ohio. The SYNERGY Stent uses the
market-leading everolimus drug and features an ultra-thin bioabsorbable
polymer coating. The absorption of the polymer is completed shortly after
drug elution ends at three months.
"SYNERGY is the most flexible, conformable and deliverable drug eluting stent
platform that I have ever deployed," said Dean Kereiakes, M.D., F.A.C.C.,
Christ Hospital and the principal investigator of the study. "I am
enthusiastic about its potential impact on patient care since the SYNERGY
System was designed to reduce the risk of late adverse events and the need for
prolonged dual antiplatelet therapy, which is often associated with a higher
risk of bleeding, as well as increased cost."
The EVOLVE II clinical trial builds upon the EVOLVE study. EVOLVE was a
prospective, randomized, single-blind, first human use study comparing the
SYNERGY Stent to the PROMUS Element Stent, which uses a durable polymer
coating. Outcomes with the SYNERGY Stent in EVOLVE were comparable to
outcomes with the PROMUS Element Stent at six months and one year.
"We continue to strengthen our drug-eluting stent portfolio with innovations
like the SYNERGY System in an effort to increase the advanced treatment
options available to physicians and patients," said Kevin Ballinger, president
of Interventional Cardiology at Boston Scientific. "This underscores our
commitment to the drug-eluting stent market and reinforces our position as a
global market leader."
Patients enrolled in the EVOLVE II trial will be followed for five years. The
SYNERGY Stent System is an investigational device in non-CE Mark countries and
is not available for sale in the United States and Japan.
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of
medical devices that are used in a broad range of interventional medical
specialties. For more information, please visit: www.bostonscientific.com.
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CONTACT: Steven Campanini
Boston Scientific Corporation
Boston Scientific Corporation
SOURCE Boston Scientific Corporation
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