Video: Boston Scientific Announces European Approval and Launch of Platinum Chromium PROMUS(R) Element(TM) Stent System

* Reuters is not responsible for the content in this press release.

Mon Nov 2, 2009 8:45am EST

Video: Boston Scientific Announces European Approval and Launch of Platinum
Chromium PROMUS(R) Element(TM) Stent System
Third-generation drug-eluting stent now available in CE Mark countries




NATICK, Mass., Nov. 2 /PRNewswire-FirstCall/ -- Boston Scientific Corporation
(NYSE: BSX) today announced it has received CE Mark for its PROMUS®
Element(TM) Everolimus-Eluting Coronary Stent System, the Company's
third-generation drug-eluting stent (DES) technology. The PROMUS Element
system incorporates a unique platinum chromium alloy with an innovative stent
design and an advanced catheter delivery system.

To view the Multimedia News Release, go to:
http://multivu.prnewswire.com/mnr/bostonscientific/36501/

(Photo:  http://www.newscom.com/cgi-bin/prnh/20091102/NY02934 )

The Company will begin marketing the PROMUS Element system immediately in the
European Union and other CE Mark countries. CE Mark was granted by the Dutch
Notified Body KEMA Quality B.V.

The platinum chromium alloy used in the PROMUS Element stent is engineered
specifically for coronary stenting. This proprietary alloy offers greater
radial strength and flexibility than older alloys such as the cobalt chromium
alloy used in the XIENCE PRIME(TM) DES, and it provides enhanced visibility
and reduced recoil. The innovative stent design improves deliverability and
allows for more consistent lesion coverage and drug distribution. The advanced
catheter delivery system further improves deliverability.

"The platinum chromium alloy and new stent design used in the PROMUS Element
stent represent significant innovations in drug-eluting stent technology,"
said Bruno Farah, M.D., Clinique Pasteur, Toulouse, France. "In my experience,
the Element platform offers a stenting option that provides superior
deliverability and visibility with excellent comformability and low recoil.  I
believe it offers performance improvements that could simplify procedures and
allow treatment of a broader range of patients."

In addition to the PROMUS Element Everolimus-Eluting Coronary Stent System,
the Company plans to offer the TAXUS® Element(TM) Paclitaxel-Eluting Coronary
Stent System. Both Element systems incorporate the platinum chromium alloy
with the innovative stent design and advanced catheter delivery system.

"We are proud to introduce our third-generation drug-eluting stent to
physicians and patients in Europe and other CE Mark countries," said David
McFaul, Boston Scientific Senior Vice President, International. "The PROMUS
Element system is the latest example of Boston Scientific's commitment to DES
market leadership and continued innovation. We also plan to launch the TAXUS
Element system in CE Mark countries next year, giving physicians the choice of
two proven drug and polymer combinations - used in millions of patients
worldwide - on an entirely new stent platform. We are confident our Element
series will further extend our global DES leadership."

The PROMUS Element system is being evaluated in the PLATINUM clinical trial,
which completed enrollment of 1,532 patients in September at more than 140
sites worldwide. PLATINUM is a randomized, controlled, pivotal trial designed
to support U.S. Food and Drug Administration (FDA) and Japanese Ministry of
Health, Labor and Welfare (MHLW) approval of the PROMUS Element system. The
TAXUS Element system is being evaluated in the PERSEUS trial, which completed
enrollment in October 2008 and will report primary endpoint data at the
American College of Cardiology conference in March.

The Company anticipates FDA approval for the PROMUS Element system in 2012.
The TAXUS Element system was launched in select international markets in May.
CE Mark approval for the TAXUS Element system is expected in the second
quarter of 2010, and FDA approval is expected in 2011.

In the U.S., the PROMUS Element and TAXUS Element systems are investigational
devices and are limited by applicable law to investigational use only and are
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 hereafter. 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.

    Press Contact:
    Paul Donovan
    Media Relations
    Boston Scientific Corporation
    508-650-8541 (office)
    508-667-5165 (mobile)

    Larry Neumann
    Investor Relations
    Boston Scientific Corporation
    508-650-8696 (office)


SOURCE  Boston Scientific

Paul Donovan, Media Relations, +1-508-650-8541 (office), +1-508-667-5165
(mobile), Larry Neumann, Investor Relations, +1-508-650-8696 (office), both of
Boston Scientific Corporation
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.