Boston Scientific Announces European Launch and First Implants of Platinum Chromium TAXUS(R) Element(TM) Stent System
By Boston Scientific International Sa, PRNEWednesday, June 9, 2010
CE Mark Approval Includes Specific Indication for Treatment of Diabetic Patients
NATICK, Massachusetts, June 10, 2010 - Boston Scientific Corporation (NYSE: BSX) today announced the
market launch and first implants of its TAXUS(R) Element(TM)
Paclitaxel-Eluting Coronary Stent System in the European Union and other CE
Mark countries. The TAXUS Element Stent System is the Company's
third-generation drug-eluting stent (DES) technology and incorporates a
platinum chromium alloy with an innovative stent design and an advanced
catheter delivery system. It received CE Mark approval last month, which
included a specific indication for the treatment of diabetic patients.
The first European implants were performed by Corrado
Tamburino, M.D., Ph.D., Chair of the Cardiology Department at Ferrarotto
Hospital, Catania, Italy and Adrian Banning, M.D., Directorate Chair of
Cardiac Services at John Radcliffe Hospital, Oxford, U.K.
"I have found the TAXUS Element Stent to offer performance
advantages in flexibility, visibility and deliverability over
prior-generation stents," said Dr. Tamburino. "The platinum chromium alloy
and new stent design used in the Element platform, together with the proven
TAXUS drug and polymer, represent a significant advance in coronary
stenting."
"The diabetic indication for the TAXUS Element Stent System
provides an important benefit given that approximately one third of all
patients presenting with coronary artery disease in Europe have diabetes,"
said Dr. Banning. "Diabetic patients with coronary artery disease often have
poorer outcomes after revascularization procedures. The paclitaxel-based
TAXUS Element Stent has a unique mechanism of action that helps inhibit
restenosis in high-risk patients with diabetes."
The TAXUS Element Stent is designed specifically for coronary
stenting and leverages the performance advantages of the Element Stent
platform with a decade of clinical success from the TAXUS program. The novel
stent architecture and proprietary platinum chromium alloy combine to offer
greater radial strength and flexibility. The stent architecture helps create
consistent lesion coverage and drug distribution while improving
deliverability, which is enhanced by an advanced catheter delivery system.
The higher density alloy provides superior visibility and reduced recoil
while permitting thinner struts compared to prior-generation stents[1].
In March, the Company announced 12-month results from its PERSEUS
clinical program demonstrating positive safety and efficacy outcomes in
workhorse lesions for the TAXUS Element Stent System compared to the TAXUS(R)
Express2(R) Stent System. Those results were recently published in the
Journal of the American College of Cardiology. The PERSEUS results also
reported a similar safety profile and statistically superior efficacy
outcomes in small vessels for the TAXUS Element Stent compared to a
historical control group of patients receiving the Express(R) bare-metal
Stent.
The Company received CE Mark approval for the PROMUS(R)
Element(TM) Everolimus-Eluting Stent System in October 2009. Both Element
Stent Systems incorporate the same platinum chromium alloy, innovative stent
design and advanced catheter delivery system.
In the U.S., the Company expects Food and Drug Administration
approval for the TAXUS Element Stent System in mid 2011 and for the PROMUS
Element Stent System in mid 2012. In Japan, the Company expects approval for
the TAXUS Element Stent System in late 2011 or early 2012 and for the PROMUS
Element Stent System in mid 2012.
In the U.S. and Japan, the TAXUS Element Stent and the PROMUS
Element Stent 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.
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[1] Based on bench testing. Data on file with Boston Scientific.
CONTACT: Paul Donovan +1-508-650-8541 (office) +1-508-667-5165 (mobile) Media Relations Boston Scientific Corporation Larry Neumann +1-508-650-8696 (office) Investor Relations Boston Scientific Corporation
CONTACT: Paul Donovan, +1-508-650-8541 (office), +1-508-667-5165 (mobile), Media Relations, Boston Scientific Corporation; Larry Neumann, +1-508-650-8696 (office), Investor Relations, Boston Scientific Corporation
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