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Boston Scientific Reveals FDA Nod, Launch Of INGENIO, ADVANTIO & INVIVE CRT-P

Boston Scientific Corp. (BSX) unveiled FDA approval and market launch of its INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers, or CRT-P.

The INGENIO and ADVANTIO pacemakers feature RightRate pacing technology designed to treat chronotropic incompetence, or 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. The company noted that the first implant of the INGENIO pacemaker in the U.S. was performed on May 3 by Bruce Wilkoff, Director of Cardiac Pacing and Tachyarrhythmia Devices at the Cleveland Clinic.

In addition to RightRate, the INGENIO pacemaker offers Respiratory Rate Trend, or RRT, an exclusive feature that monitors respiration, a key vital sign. The INVIVE CRT-P offers RRT as part of HF Perspectiv, a comprehensive suite of heart failure diagnostics designed to provide health care professionals with additional information to guide treatment decisions.

The INGENIO, ADVANTIO and INVIVE devices are designed for use with Boston Scientific's new LATITUDE NXT Remote Patient Management system, which is currently under review by the FDA, and will enable physicians to conduct remote follow-ups of these device patients to monitor specific pacemaker information and heart health status.

by RTT Staff Writer

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