Boston Scientific Announces FDA Approval of New Family of Advanced Pacemakers
NATICK, Mass., May 8 /PRNewswire-FirstCall/ — Boston Scientific Corporation today announced U.S. Food and Drug Administration (FDA) approval of its ALTRUA(TM) family of pacemakers. ALTRUA is Boston Scientific’s most advanced pacemaker and delivers enhanced therapies while maintaining its small size and battery longevity. It is the first Boston Scientific-branded pacemaker to treat bradycardia, a condition in which the heart beats too slowly — usually less than 60 beats per minute — depriving the body of sufficient oxygen.
“FDA approval of Boston Scientific’s ALTRUA family of pacemakers — especially following the European approval of ALTRUA we announced yesterday — further demonstrates the significant progress we have made rebuilding our CRM organization and reinvigorating our product pipeline,” said Fred Colen, Executive Vice President, Operations and Technology, Cardiac Rhythm Management. “Pacemakers are the most implanted device in the cardiac rhythm management industry and we look forward to making the ALTRUA family broadly available to physicians and their patients.”
The ALTRUA pacemaker provides physicians with diagnostic and therapeutic capabilities that enable them to tailor the therapy to meet specific patient requirements:
— Multiple Atrial Ventricular (AV) Delay programming options: These options are designed to reduce unnecessary right ventricular (RV) pacing, without dropping ventricular beats, a key distinction from other competitive RV pacing algorithms. The ALTRUA 60 series also includes an enhanced AV search hysteresis feature, now with an extendable AV delay out to 400 milliseconds, providing physicians with additional flexibility to tailor device programming for unique patient needs. — Stored Onset Electrograms (EGM): This feature provides diagnostic information about the patient’s heart rhythm before the onset of an arrhythmia, enabling physicians to more easily and effectively troubleshoot patient arrhythmias. Boston Scientific’s proprietary design enables continuous onset EGM monitoring without reducing battery longevity, a key difference from most competitive pacemakers. — Minute Ventilation (MV) Blended Sensor: This proprietary technology treats a condition called Chronotropic Incompetence (CI), which is the inability of the heart to regulate its rate appropriately in response to physical activity and emotional stress. Boston Scientific’s MV Blended Sensor is the only sensor that has been shown to restore Chronotropic Competence, enabling a patient’s heart rate to function appropriately in different situations such as carrying groceries or climbing stairs. This feature is only available in the ALTRUA 60 and 40 series.
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/.
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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
Boston Scientific Corporation
CONTACT: Paul Donovan, Media Relations, +1-508-650-8541 (office),+1-508-667-5165 (mobile), or Larry Neumann, Investor Relations,+1-508-650-8696 (office), both of Boston Scientific Corporation
Web site: http://www.bostonscientific.com/