NATICK, Mass., May 31, 2012 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved revised product labeling for the Boston Scientific Corporation (NYSE: BSX) INCEPTA(TM), ENERGEN(TM), PUNCTUA(TM), COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), to reflect increased longevity projections for these devices. The longevity projections are based on data submitted to the FDA and vary for each device dependent on the model type and settings.
Projected device longevity exceeds 10 years for some models of Boston Scientific ICDs, and approaches eight years for its CRT-D devices, and nearly double that of comparable competitive device models (1,2,3). The company backs these devices with warranties of up to 10 years* in the U.S. and many other international markets. Depending on the model, the device warranties are also up to twice as long as other currently-marketed comparable devices.
"We're pleased with the new labeling for our U.S. defibrillator products which provides doctors and patients with additional assurance about the longevity and reliability of these devices," said Kenneth Stein, M.D., chief medical officer of Boston Scientific's Cardiac Rhythm Management Group. "Boston Scientific ICDs and CRT-Ds benefit from our proprietary advanced battery technology. The new battery was first introduced in the COGNIS and TELIGEN devices in 2008 and has now been incorporated into our newest devices with up to a 10-year warranty."
"The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) long-term follow-up study results, which were recently presented at the Heart Rhythm Society annual meeting in Boston, demonstrates that ICD therapy continues to benefit patients for a median follow-up of 11 years. Particularly in New York Heart Association Class II patients, it appears that an ICD may prolong a patient's life for at least a decade by rescuing the patient from sudden cardiac death," said Jeanne Poole, M.D., director, Arrhythmia Service and Electrophysiology Laboratory at the University of Washington Medical Center in Seattle. "By helping to mitigate the frequency of replacing an ICD or CRT-D device, this technology provides us with the potential to reduce the complications associated with replacement procedures and to reduce healthcare costs. Not only does the patient benefit from fewer surgeries, but the financial benefit can be significant."
*INCEPTA & ENERGEN VR ICD: 10 years; INCEPTA & ENERGEN DR ICD: 8 years; PUNCTUA & TELIGEN ICD: 7 years; INCEPTA & ENERGEN CRT-D: 6 years; and PUNCTUA & COGNIS CRT-D: 5 years.
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
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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.
(1) PUNCTUA(TM) ICD, ENERGEN(TM) ICD, INCEPTA(TM) ICD - PHYSICIAN'S TECHNICAL MANUAL
Part Number: 358362-006, 5-22-12; TELIGEN® 100 - PHYSICIAN'S TECHNICAL MANUAL
Part Number: 357449-010, 5-22-12; PUNCTUA(TM) CRT-D, ENERGEN(TM) CRT-D, INCEPTA(TM) CRT-D - PHYSICIAN'S TECHNICAL MANUAL Part Number: 358373-007, 5-22-12; COGNIS® 100-D - PHYSICIAN'S TECHNICAL MANUAL Part Number: 357483-012, 5-22-12.( )
(2) Based on Boston Scientific calculations using 17-26% current drain for Onset EGMs ON and one additional max energy charge per year.
(3) Medtronic Protecta XT CRT-D D314DRG Clinician Manual, M930564A001 2010-02-19; Medtronic Protecta XT ICD DR D314DRG Clinician Manual, M930566A001 2010-10-19;( )Medtronic Protecta XT ICD VR D314VRG Clinician Manual, M930568A001 2010-10-19.
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SOURCE Boston Scientific Corporation