Boston Scientific Begins Clinical Trial Enrollment for New Everolimus-Eluting Stent PLATINUM clinical program
to evaluate PROMUS™ Element™ Platinum
Chromium Stent
February 3, 2009 -- Natick, Mass. --
Boston Scientific Corporation today announced the beginning of patient
enrollment in the PLATINUM clinical trial, which is designed to evaluate
the Company's PROMUS™ Element™ 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™ 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® 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™ 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."
Gregg W.
Stone, MD
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,"
"believe," "plan," "estimate," "intend" and
similar words. These forward-looking statements are based on our beliefs,
assumptions and estimates using information available to us at the
time and are not intended to be guarantees of future events or performance.
These forward-looking statements include, among other things, statements
regarding clinical trials, regulatory approvals, competitive offerings,
product performance and our market position. If our underlying assumptions
turn out to be incorrect, or if certain risks or uncertainties materialize,
actual results could vary materially from the expectations and projections
expressed or implied by our forward-looking statements. These factors,
in some cases, have affected and in the future (together with other
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and may cause actual results to differ materially from those contemplated
by the statements expressed in this press release. As a result, readers
are cautioned not to place undue reliance on any of our forward-looking
statements. Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A - Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A - Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file thereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
Source: Boston Scientific Corporation
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