Boston Scientific Corporation (NYSE:BSX), Natick, Mass., has
announced the beginning of clinical trial enrollment in studies
evaluating its third-generation paclitaxel-eluting coronary stent, the
TAXUS(R) Element(TM) Stent. The TAXUS PERSEUS clinical program will
collectively enroll approximately 1,500 patients at 100 U.S. and
international centers.
The TAXUS Element Stent features the proprietary Platinum Chromium
Alloy, designed specifically for stents. This alloy, coupled with an
innovative new stent design, is designed to enable thinner struts,
increased flexibility, and a lower profile while improving radial
strength, recoil, and radiopacity. In addition, the TAXUS Element Stent
platform incorporates new balloon technology, intended to improve upon
Boston Scientific's market-leading Maverick(R) Balloon Catheter
technology.
The principal investigator for the trials is Dean J. Kereiakes,
M.D., Medical Director at The Christ Hospital Heart and Vascular Center
and The Lindner Research Center in Cincinnati. The co-principal
investigator is Louis A. Cannon, M.D, of the Cardiac and Vascular
Research Center of Northern Michigan in Petoskey, Michigan. Patient
enrollment of the TAXUS PERSEUS clinical program began July 13th and is
expected to be completed within 12 months.
"With the innovative design of the TAXUS Element Stent System,
we anticipate seeing a significant advancement in the performance
offered in a drug-eluting stent," said Dr. Kereiakes. "This
new platform, designed for improved deliverability, should allow us to
bring the long-term proven performance of the TAXUS Stent to even the
most complex and challenging anatomy."
The TAXUS PERSEUS clinical program will evaluate the efficacy and
safety of the TAXUS Element Stent in two studies.
The first study, TAXUS PERSEUS Workhorse (A Prospective Evaluation
in a Randomized Trial of the Safety and Efficacy of the Use of the
TAXUS(R) Element(TM) Paclitaxel-Eluting Coronary Stent System for the
Treatment of De Novo Coronary Artery Lesions), will evaluate the safety
and efficacy of the TAXUS Element Stent compared to Boston
Scientific's first generation drug-eluting stent, the TAXUS(R)
Express2(TM) Stent. This study will evaluate 1,264 patients with
"workhorse" lesions from 2.75 to 4.0 millimeters. The primary
endpoint of the workhorse study is target lesion failure (TLF) at 12
months, and its secondary endpoint is in-segment percent diameter
stenosis at nine months.
The second study is the TAXUS PERSEUS Small Vessel study which will
compare the TAXUS Element Stent to a historic control (TAXUS V de novo
bare-metal Express(R) Coronary Stent System). This study will include
224 patients with lesions from 2.25 up to 2.75 millimeters. The primary
endpoint of the small vessel study is in-stent late loss at nine months,
and its secondary endpoint is TLF at 12 months. Study success is
dependent on both endpoints.
"We are excited to begin evaluating the TAXUS Element Stent,
the third in our deep pipeline of drug-eluting stents, a milestone
unmatched by other companies," said Hank Kucheman, senior vice
president and group president, Interventional Cardiology. "The
Platinum Chromium Alloy and new balloon technologies offered in this
system are also being developed in an Everolimus version and is intended
to serve as foundational technology in Boston Scientific's
dual-drug DES portfolio, including a drug-eluting bifurcation stent and
next-generation Everolimus- and Paclitaxel-eluting stents."
The TAXUS Element Stent is under development and is not available
for sale.
Boston Scientific is a worldwide developer, manufacturer and
marketer of medical devices whose products are used in a broad range of
interventional medical specialties.
For more information, visit http://www.bostonscientific.com or call
508/650-8541.
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