Healthcare Industry News: PROMUS Element
News Release - February 4, 2009
Boston Scientific Begins Clinical Trial Enrollment for New Everolimus-Eluting Stent
PLATINUM clinical program to evaluate PROMUS(TM) Element(TM) Platinum ChromiumStent
NATICK, Mass., Feb. 3 (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation
today announced the beginning of patient enrollment in the PLATINUM clinical
trial, which is designed to evaluate the Company's PROMUS(TM) Element(TM)
Everolimus-Eluting Coronary Stent. The first U.S. patient was enrolled last
week at the Medical Center of the Rockies in Loveland, Colorado by Thomas
Downes, M.D. The first Japanese patient was also enrolled last week.
The PLATINUM clinical program will enroll 1,728 patients at 160 sites
worldwide. The trial will compare the PROMUS Element Everolimus-Eluting
Coronary Stent to the PROMUS(TM) Everolimus-Eluting Coronary Stent. The
Company plans to develop additional variations of the Element Stent platform,
including next generations of a bare-metal stent and a paclitaxel-eluting
TAXUS(R) Element Stent.
The Element Stent platform features a proprietary Platinum Chromium Alloy,
designed specifically for coronary stents. This alloy, coupled with a new
stent architecture, is designed to enable thinner struts, increased
flexibility and a lower profile while improving radial strength, recoil and
visibility. In addition, the PROMUS Element Stent System incorporates the
new Apex(TM) Dilatation Catheter technology, designed to enhance
deliverability to complex lesions.
"We are excited to begin evaluating the everolimus version of our
third-generation Element Stent," said Keith Dawkins, M.D., Senior Vice
President and Associate Chief Medical Officer for Boston Scientific. "The
advanced Platinum Chromium Alloy and new balloon catheter offered in the
Element Stent System represent significant improvements. Boston Scientific
is the only company to offer interventional cardiologists a choice of two
different drugs on its drug-eluting stent (DES) platform."
The global Principal Investigator for the trial is Gregg W. Stone, M.D., of
Columbia University Medical Center and the Cardiovascular Research Foundation
in New York. The U.S. Co-Principal Investigator is Paul Teirstein, M.D., of
Scripps Green Hospital in La Jolla, California, and the International
Co-Principal Investigator is Ian Meredith, M.D., Ph.D., Director of
Cardiology at the Monash Medical Centre in Melbourne, Australia.
"The new alloy and stent design of the PROMUS Element Stent promise to offer
improved deliverability and visibility, even in patients with complex and
challenging anatomy," said Dr. Stone. "I am enthusiastic about the
possibility of having both everolimus and paclitaxel versions of this
innovative stent system available, allowing for the tailored treatment of
patients with coronary artery disease."
"Patient enrollment in the PLATINUM trial is scheduled to be completed by
October," said Hank Kucheman, Senior Vice President and Group President,
Cardiovascular for Boston Scientific. "This should enable U.S. and Japanese
launches of an internally developed everolimus stent -- PROMUS Element --
consistent with the expiration of our existing PROMUS supply agreement in
mid-2012. We plan to launch PROMUS Element in Europe during the fourth
quarter of this year."
The PLATINUM clinical program will evaluate the safety and efficacy of the
PROMUS Element Stent in three studies.
The first, PROMUS PLATINUM Workhorse, will evaluate the safety and efficacy
of the PROMUS Element Stent compared to Boston Scientific's PROMUS Stent.
This 1:1 randomized study will evaluate 1,532 patients from 160 global sites
with de novo "workhorse" lesions from 2.50 to 4.25 mm in diameter and less
than 24 mm in length. The primary endpoint of the workhorse study is target
lesion failure (TLF) at 12 months, with clinical follow-up scheduled out to
five years.
Two additional parallel studies will evaluate the PROMUS Element Stent in
small vessels and long lesions. The small vessel study will examine lesions
from 2.25 to 2.50 mm in diameter and less than or equal to 28 mm in length,
while the long lesion study will examine lesions from 2.50 to 4.25 mm in
diameter and 24 to 34 mm in length. The primary endpoint of both studies is
TLF at 12 months.
The PROMUS Element Stent is an investigational device and is limited by
applicable law to investigational use only 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, please visit:
www.bostonscientific.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934. Forward-looking
statements may be identified by words like "anticipate," "expect," "project,"
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Source: Boston Scientific
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