Boston Scientific Reports Strong Performance Data For SYNERGY? Stent System - Applied Clinical Trials

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Boston Scientific Reports Strong Performance Data For SYNERGY? Stent System EVOLVE Study Data Presented Today at EuroPCR 2014 Also Demonstrate Excellent Safety Profile


Boston Scientific Reports Strong Performance Data For SYNERGY™ Stent System

EVOLVE Study Data Presented Today at EuroPCR 2014 Also Demonstrate Excellent Safety Profile

PR Newswire

NATICK, Mass., May 21, 2014 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reported positive three-year follow-up data for the EVOLVE clinical trial, comparing the safety and performance of the SYNERGY™ Everolimus-Eluting Bioabsorbable Polymer Platinum Chromium (PtCr) Coronary Stent System to the PROMUS Element™ Stent System. 

The data were presented today at EuroPCR 2014 by Professor Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia.  The primary clinical and angiographic endpoints of this non-inferiority study have already been published.

"The SYNERGY Stent three-year results from the EVOLVE trial continue to show promise with respect to safety and efficacy," said Meredith.  "Target lesion revascularization remains very low, at a rate of 1.1 percent, while there is no stent thrombosis in the SYNERGY full-dose arm at three years.  The EVOLVE clinical data support the hypothesis that this novel bioabsorbable polymer stent technology could allow for improved healing over durable polymer DES."

Boston Scientific has expanded its commercial launch of the SYNERGY Stent System in Europe and in select markets in Asia.  It features an ultrathin abluminal bioabsorbable drug/polymer coating technology which eliminates long-term polymer exposure.  In addition to reducing restenosis, the SYNERGY Stent System may also offer faster and more complete vessel healing after stent implantation, potentially reducing the duration of post-procedure dual antiplatelet therapy.

"The SYNERGY Stent System underscores our ongoing commitment to delivering meaningful innovation to the interventional cardiology community and is expected to reinforce our position as a global leader in medical devices," said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific.  "The SYNERGY Stent System is uniquely designed to provide exceptional outcomes in complex cases by promoting early healing and eliminating long-term polymer exposure.

The SYNERGY Stent System is supported by a rigorous clinical program.  Beyond the EVOLVE Study three-year results, the EVOLVE II Clinical Trial, which completed enrollment in August 2013, is the pivotal trial designed to support U.S. Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare approval of the SYNERGY Stent System.  EVOLVE II is a global, multicenter, randomized, controlled pivotal trial that enrolled 1,684 patients in 125 sites worldwide, including the U.S., Canada, Europe, Australia, New Zealand, Japan and Singapore.  Additional studies to assess outcomes, including the potential for reduced dual antiplatelet therapy, will be supported by Boston Scientific.  The SYNERGY Stent System is being investigated in multiple independent, real-world studies across the spectrum of cardiovascular disease complexity.  For more information on the SYNERGY Stent System Clinical Program, click here.

The SYNERGY Stent System is an investigational device in the U.S. and Japan, and is not available for sale in those countries. 

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 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 markets for our products, our business plans, clinical trials and data impact, 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.

CONTACTS: 
Media: Ryan Davenport
Global Media Relations
Boston Scientific Corporation
763-494-2664 (office)
media@bsci.com

Simonetta Balbi
PR and Corporate Communication EMEA
Boston Scientific Corporation
+ 39 3387936422 (mobile)
+ 39 0106060281 (direct)
Balbis@bsci.com

Investors: Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
508-652-5345 (office)
investor_relations@bsci.com

 

SOURCE Boston Scientific Corporation

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