Boston Scientific (BSX) Gets FDA Approval for INGENIO, ADVANTIO, and INVIVE

May 7, 2012 8:32 AM EDT Send to a Friend
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Boston Scientific Corporation (NYSE: BSX) announces U.S. Food and Drug Administration (FDA) approval and market launch of its INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers (CRT-P). The first implant of the INGENIO pacemaker in the U.S. was performed on May 3 by Bruce L. Wilkoff, M.D., Director of Cardiac Pacing and Tachyarrhythmia Devices at the Cleveland Clinic.

Pacemakers are designed 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. The INGENIO and ADVANTIO pacemakers feature RightRate™ pacing technology designed to treat chronotropic incompetence (CI). CI is the inability of the heart to regulate its rate appropriately in response to physical activity, which may cause patients to feel tired or short of breath during daily activities such as walking or climbing stairs. RightRate employs Boston Scientific's minute ventilation (MV) sensor, the only sensor clinically proven to restore chronotropic competence, and adds programming options to promote ease of use and in-clinic time savings.


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