BOSTON SCIENTIFIC ANNOUNCES EUROPEAN APPROVAL AND LAUNCH OF OMEGA(TM) PLATINUM CHROMIUM STENT SYSTEM
By Boston Scientific Corporation, PRNESunday, March 6, 2011
Third-generation bare-metal stent now available in CE Mark countries
NATICK, Massachusetts, March 7, 2011 - Boston Scientific Corporation (NYSE: BSX) today announced it
has received CE Mark for its OMEGA(TM) Platinum Chromium Bare-Metal Coronary
Stent System, the Company's third-generation coronary stenting technology.
The OMEGA Stent System incorporates a unique platinum chromium (PtCr) alloy
designed specifically for coronary stenting and is intended to provide
interventional cardiologists a bare-metal stent with improved acute
performance in treating patients with coronary artery disease. The Company
will begin marketing the OMEGA Stent System immediately in the European Union
and other CE Mark countries.
"In my experience, the platinum chromium alloy and stent
design used in the OMEGA Stent offer excellent deliverability, visibility and
conformability without sacrificing radial strength or resistance to stent
recoil," said Antonio Colombo, M.D., Director of the Cardiac Catheterization
Laboratory at Columbus Hospital and San Raffaele Hospital in Milan, Italy.
"The OMEGA Stent and platinum chromium alloy offer meaningful performance
improvements without the tradeoffs associated with older stent alloys."
The OMEGA Stent System is part of the Company's PtCr Stent
series, which includes the TAXUS(R) Element(TM) Paclitaxel-Eluting Stent and
PROMUS Element(TM) Everolimus-Eluting Stent Systems. All three stents feature
the novel PtCr alloy and an innovative stent design, which combine to offer
greater radial strength and flexibility while reducing stent recoil. The
higher density alloy provides superior visibility while permitting thinner
struts compared to prior-generation stents[1]. The enhanced delivery system
features a dual-layer balloon and is engineered to improve access to
challenging lesions.
"The platinum chromium PROMUS Element and TAXUS Element Stents
have been well received by physicians since their launch in CE Mark
countries, and we are pleased to now offer a bare-metal coronary stent built
on the same PtCr platform," said Mike Phalen, Executive Vice President and
President, International for Boston Scientific. "The OMEGA Stent is the
latest example of Boston Scientific's commitment to continued innovation in
coronary stenting. We are confident our platinum chromium stent technology
will further extend our worldwide stent market leadership."
"The positive clinical data from our PtCr (Element) series
trials support the acute performance benefits provided by our new platinum
chromium stent platform," said Keith D. Dawkins, M.D., Senior Vice President
and Chief Medical Officer for Boston Scientific's Cardiology, Rhythm and
Vascular Group. "The OMEGA Stent complements the PtCr Stent series to provide
a full range of coronary stenting solutions for interventional cardiologists,
giving them the option to treat patients with a paclitaxel, everolimus or
bare-metal stent."
The OMEGA Stent is offered in 48 different sizes ranging in
diameter from 2.25 mm to 4.50 mm and lengths of 8 mm to 32 mm. Boston
Scientific offers the most comprehensive coronary stent portfolio in the
industry, offering physicians and their patients the broadest size matrix and
the industry's only two-drug platform. The Company received CE Mark approval
for the PROMUS Element Everolimus-Eluting Stent System in October 2009 and
for the TAXUS Element Paclitaxel-Eluting Stent System in May 2010.
About Boston Scientific
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 27A of the Securities Act of 1933 and 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.
CONTACT: Geraldine Varoqui Boston Scientific PR Director International Tel: +49-2102-489-461 varoquig@bsci.com [1] Based on bench testing. Data on file with Boston Scientific.
CONTACT: Geraldine Varoqui, Boston Scientific PR Director International, Tel: +49-2102-489-461, varoquig at bsci.com
Tags: Boston Scientific Corporation, March 7, Massachusetts, Natick