Healthcare Industry News:  dilatation catheter 

Devices Interventional Cardiology

 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 Chromium
Stent


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,"
"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 factors) could affect our ability to
implement our business strategy 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

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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