Corporation (NYSE: BSX) today announced the successful implantation of the
Company's TAXUS(R) Petal(TM) Bifurcation Paclitaxel-Eluting Stent System
(TAXUS Petal Stent) in a patient in New Zealand, marking the beginning of
the TAXUS PETAL I First Human Use (FHU) Trial. The trial is designed to
evaluate the safety of a dedicated bifurcation paclitaxel-eluting stent
platform for the treatment of coronary artery disease. The procedure was
performed by John Ormiston, M.D., at Auckland City Hospital in Auckland,
New Zealand.
A significant percentage of coronary artery disease -- as much as 30
percent -- occurs at a bifurcation, where one artery branches into two
smaller arteries (one being the continuation of the main branch and the
other often referred to as the side branch). Bifurcations present a common
location for the buildup of plaque and are particularly difficult to treat
with currently available stents. Conventional coronary stents were designed
to treat tubular arteries and are considered less than optimal for the
y-shaped anatomy of a bifurcation. The TAXUS Petal Stent is designed
specifically to treat both the main branch and the side branch of a
bifurcation.
The TAXUS Petal Stent consists of a traditional drug-eluting stent with
an innovative side structure (the Petal Strut) in the middle of the stent
that opens into the side branch. The TAXUS Petal is designed to provide
access, coverage and support to the critical areas of the bifurcation and
uses a proprietary platinum chromium alloy. Platinum chromium is designed
to offer an improvement over stainless steel and cobalt chromium, enabling
even thinner struts, increased flexibility and improved radiopacity. The
TAXUS Petal Stent is coated with the proven, market-leading combination of
the Paclitaxel drug and Translute(TM) polymer.
"The TAXUS Petal Stent enabled us to successfully treat a patient with
a difficult bifurcation (coronary branch point) stenosis. Bifurcations are
a major challenge in interventional cardiology, and the development of a
dedicated drug-eluting bifurcation stent is an important advancement," said
Dr. Ormiston, the principal investigator for the TAXUS Petal I FHU Trial.
"A major strength of the TAXUS Petal Stent design is to provide consistent
mechanical support and drug application not only to the main branch and but
also to the side-branch ostium, where renarrowing is common with other
techniques used today."
The TAXUS PETAL I FHU clinical trial is a non-randomized study with an
initial assessment of acute performance and safety (death, myocardial
infarction, target vessel revascularization) at 30 days and six months, as
well as continued annual follow-up for five years. TAXUS PETAL I FHU will
enroll a total of 45 patients in New Zealand, France and Germany. Upon
successful completion of this study, Boston Scientific intends to begin a
pivotal trial to gain U.S. and international approval for the
commercialization of the TAXUS Petal Stent.
"We are excited about the start of the TAXUS PETAL I FHU Trial," said
Hank Kucheman, Senior Vice President and Group President, Interventional
Cardiology. "Boston Scientific is committed to developing innovative
technologies that enable physicians to treat their most difficult patients.
The TAXUS Petal Stent program reinforces our unparalleled pipeline of
developing stent technologies."
The TAXUS Petal Stent is under development and 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, please visit:
bostonscientific.
This press release contains forward-looking statements. Boston
Scientific wishes to caution the reader of this press release that actual
results may differ from those discussed in the forward-looking statements
and may be adversely affected by, among other things, risks associated with
product development and commercialization, clinical trials, intellectual
property, regulatory approvals, competitive offerings, Boston Scientific's
overall business strategy, and other factors described in Boston
Scientific's filings with the Securities and Exchange Commission.
Boston Scientific Corporation
bostonscientific
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