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Boston Scientific Recognized As Leader in Development of Rigorous Clinical Trials

Posted on: Wednesday, 19 October 2005, 09:01 CDT

NATICK, Mass. and WASHINGTON, Oct. 19 /PRNewswire-FirstCall/ -- Boston Scientific Corporation was recognized by physicians as a leader in the pursuit of evidence-based medicine through increased use of randomized controlled clinical trials. The comments were made during the annual Transcatheter Cardiovascular Therapeutics symposium, in Washington, D.C. The clinical program supporting the Company's TAXUS(R) Express2(TM) paclitaxel- eluting coronary stent system was cited as the type of definitive medical evidence that physicians should use in making treatment decisions.

The importance of evidence-based medicine was highlighted at a scientific symposium, which included a presentation titled "Evidence-Based Medicine and Best Practices with Drug-Eluting Stents" and addressed the quality of randomized controlled clinical trials and illustrated how designs with varying quality can yield significantly different results. Specific trial features that have proven especially valuable include: clearly defined endpoints, proper sample size, multi-center, full accounting of patients and independent analysis.

"Physicians today need to make their decisions based on adequately powered trials with clinical outcomes as a primary endpoint," said Prof. Sigmund Silber, M.D., F.A.C.C., F.E.S.C., Co-chairman of the symposium. "Non-blinded, single-center trials are not sufficient as a basis for instructing treatment decisions or making drug-eluting stent comparisons. Boston Scientific is conducting the type of clinical trials that are consistent with strict scientific criteria that physicians need to consider when evaluating their impact on the decision-making process for their patients."

"Nearly all clinical trials are well-intended to build scientific knowledge but very few measure up to the exacting criteria needed to drive evidence-based medicine," said Ron Waksman, M.D., of the Cardiovascular Research Institute in Washington, D.C. "It is important to base clinical judgment on data derived from rigorous clinical trials with clearly defined endpoints that provide physicians with conclusive and scientific demonstration of safety and efficacy in the more complex patient populations. I am pleased to see Boston Scientific setting a standard within the industry for collecting solid data that supports evidence-based decisions for the growing number of physicians using drug-eluting stents."

"Our approach to working with the medical community to conduct clinical trials is built on evidence-based medicine," said Dr. Mary Russell, Senior Vice President for Clinical and Regulatory and Chief Medical Officer, Boston Scientific. "We strive for scientific rigor and innovation in endpoints and analysis to ensure the data is relevant, complete, rapidly available and shared openly with clinicians, hospitals and patients. We are proud of our standards and we will continue to drive evidence-based decisions with our clinical studies."

Last month, Boston Scientific announced that its TAXUS IV, V and VI clinical trials met the treatment guidelines criteria established by the European Society of Cardiology Taskforce for Percutaneous Coronary Intervention for the use of drug-eluting coronary stents (DES). The guidelines were designed earlier this year to provide physicians with recommendations for DES treatment decisions based on the level of evidence demonstrated in clinical trials.

Evidence-based medicine is intended to improve individual clinician's decisions about managing patients. The approach emphasizes the use of the best evidence based on scientifically robust studies to achieve informed decisions that can be implemented for specific patient care. Evidence-based medical care makes it possible to access established knowledge bases and answer clinical questions at the point of care in real time. One example is the recently launched "Evidence Based Medicine Center" on the TCTMD website at http://www.tctmd.com/.

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: http://www.bostonscientific.com/.

This press release contains forward-looking statements. Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.

CONTACT: Milan Kofol 508-650-8569 (Office) Investor Relations Boston Scientific Corporation Paul Donovan 508-650-8541 (Office) 508-667-5165 (Mobile) Media Relations Boston Scientific Corporation

Boston Scientific Corporation

CONTACT: Milan Kofol, Investor Relations, +1-508-650-8569, or PaulDonovan, Media Relations, +1-508-650-8541 (Office), +1-508-667-5165 (Mobile)both of Boston Scientific Corporation

Web site: http://www.bostonscientific.com/

Source: PRNewswire-FirstCall

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