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Boston Scientific's Most Advanced Devices to Treat Heart Failure and Sudden Cardiac Death Now Available in Japan

Posted : Mon, 09 Nov 2009 13:32:21 GMT
Author : Boston Scientific Corporation
Category : Press Release
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NATICK, Mass., Nov. 9 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced the launch of its COGNIS® cardiac resynchronization therapy defibrillator (CRT-D) and TELIGEN® implantable cardioverter defibrillator (ICD) in Japan. These devices were approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) in August and received reimbursement approval in September. COGNIS and TELIGEN are the result of a multi-year research and development effort to provide physicians enhanced clinical options for their patients.

"Boston Scientific is committed to providing Japanese physicians and their patients the most innovative products and therapies," said David McFaul, Boston Scientific Senior Vice President, International. "COGNIS and TELIGEN are now part of Boston Scientific's full product portfolio in Japan, which also includes the Company's newest and most advanced pacemaker -- the ALTRUA(TM) 60."

"The significantly reduced size of these devices has been well received by physicians in the U.S. and Europe, resulting in more than 75,000 implants in less than two years," said Ken Stein, M.D., Associate Chief Medical Officer, Boston Scientific CRM. "In the past, physicians often had to make trade-offs among device size, battery longevity and features when prescribing a high-energy device. These devices eliminate those trade-offs without compromising therapy options."

The COGNIS CRT-D and TELIGEN ICD are the world's smallest and thinnest high-energy devices at 32.5 cc and 31.5 cc respectively, while less than 10 mm thick. Both devices offer features based on substantial engineering advances, including extended battery longevity, self-correcting software and improved programming technology.

Both devices offer a redundant hardware system called SafetyCore(TM), which provides life-saving shock therapy and basic pacing functionality in the unlikely event of a system error. The devices employ digital signal processing and are equipped with increased levels of digital memory, enabling more patient data to be captured and used by physicians.

Key features of the COGNIS CRT-D include:

  • SmartDelay(TM) -- quickly proposes programmable device settings, which enables physicians to tailor individualized pacing therapy for their patients.
  • Bi-V Trigger -- helps physicians manage heart failure patients with frequent atrial arrhythmias.
  • Electronic Repositioning(TM) -- provides physicians with six configurations for stimulating the left side of the heart even after implant, which may help avoid an additional surgical procedure.

Key features of the TELIGEN ICD include:

  • Smallest and thinnest high-energy ICD device available in the world -- the small size and physiological shape are designed with patient comfort in mind.
  • Quick Convert(TM) -- provides the ability for patients to receive pacing therapy for ventricular tachycardias.
  • Reverse Mode Switch(TM) -- provides physicians more options for minimizing right ventricular (RV) pacing.

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 our product performance, regulatory approval of our products, new product launches, competitive offerings, our growth strategy, 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: Paul Donovan
             508-650-8541 (office)
             508-667-5165 (mobile)
             Media Relations
             Boston Scientific Corporation

             Larry Neumann
             508-650-8696 (office)
             Investor Relations
             Boston Scientific Corporation

SOURCE Boston Scientific Corporation


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