Breaking

Japan Nov. Unemployment Rate At 3.5%, Matching Estimate
Tweet TWEET

Boston Scientific Reports Favorable Six-Month Results From Lotus™ Valve System Clinical Trial

Boston Scientific Reports Favorable Six-Month Results From Lotus™ Valve System
                                Clinical Trial

  PR Newswire

  NATICK, Massachusetts, September 17, 2013

NATICK, Massachusetts, September 17, 2013 /PRNewswire/ --

REPRISE II Data Honored as Best Abstract 2013 at PCR London Valves Course

Boston Scientific Corporation (NYSE: BSX) reported favorable six-month results
from the first 60 patients enrolled in the REPRISE II clinical trial
evaluating the safety and performance of the Lotus™ Valve System in
symptomatic patients with severe aortic stenosis considered at high risk for
surgical valve replacement. 

The data, which were presented today at PCR London Valves and formally
received the honor of Best Abstract 2013, demonstrated excellent results with
no new valve-related adverse events between 30 days and six months.
Additionally, there were no cases of moderate or severe paravalvular
regurgitation in any patient at six months.

Six-month results:

  *Excellent hemodynamic results continue to be observed at six months as
    demonstrated by mean aortic valve pressure gradient of 12.1 ± 5.0 mmHg and
    mean aortic valve area of 1.8 ± 0.5 cm ^2 .
  *Independent core lab assessment of paravalvular aortic regurgitation
    showed 76.1 percent of patients presenting with no paravalvular
    regurgitation and no cases of moderate or severe regurgitation.
  *There were no new valve-related adverse events recorded between 30 days
    and six months.
  *The NYHA classification data demonstrated a significant improvement in
    heart failure symptoms at six months compared to baseline.

"The Lotus Valve System provides the operator with superb control allowing
precise positioning and accurate deployment," said Professor Ian Meredith,
director of MonashHeart at Monash Medical Centre in Melbourne, Australia, and
principal investigator of the REPRISE II trial. "The results from the first 60
patients of the REPRISE II trial are very impressive, especially with no
patients presenting with moderate or severe paravalvular regurgitation at six
months."

The Lotus Valve System is the first transcatheter aortic valve replacement
(TAVR) device of its kind with an Adaptive™ Seal that is designed to minimize
aortic regurgitation (leaking) around the valve, a proven predictor of
mortality, and is both fully repositionable and retrievable prior to release.

Boston Scientific expects to release additional REPRISE II data in late
October at the TCT (Transcatheter Cardiovascular Therapeutics) conference in
San Francisco.

"The latest results from REPRISE II underscore the promising and unique
technology behind the Lotus Valve System, demonstrating how the Lotus Valve
System can offer a new treatment alternative for patients with severe aortic
valve disease," said Keith Dawkins, M.D., global chief medical officer, Boston
Scientific."These features help to simplify the implantation procedure and
may lead to improved clinical outcomes."

The Lotus Valve System is an investigational device worldwide and not
available for sale. To view the Multimedia News Release including videos,
backgrounders and images, please click here:
http://www.epresspack.net/lotus-valve-system .

The results of the REPRISE clinical trial program are expected to be used to
support CE Mark and other international regulatory approvals.

About REPRISE II

REPRISE II is an ongoing prospective, single-arm study that has completed
enrollment of 120 patients at 14 sites in Australia, France, Germany and the
United Kingdom. All patients had severe symptomatic aortic stenosis and were
considered at high risk for surgical valve replacement. An additional 130
patients are expected to be enrolled at a total of 20 sites in Australia and
Europe in an extension of REPRISE II.

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that
improve the health of patients around the world. As a global medical
technology leader for more than 30 years, we advance science for life by
providing a broad range of high performance solutions that address unmet
patient needs and reduce the cost of healthcare. For more information, visit
http://www.bostonscientific.com and connect on Twitter and Facebook .

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 regulatory approvals, clinical trials, product performance and
impact, and competitive offerings. 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: Sandra Wagner, Weber Shandwick, +49-151-61-33-64-11 (mobile),
swagner@webershandwick.com; Simonetta Balbi, +39-3387936422 (mobile),
+39-0106060281 (direct), PR and Corporate Communication Europe, Boston
Scientific Corporation, Balbis@bsci.com
 
Press spacebar to pause and continue. Press esc to stop.