Bos Sci nets FDA thumbs-up for new pacemakers

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The FDA has approved Boston Scientific’s Ingenio and Advantio pacemakers and Invive cardiac resynchronization therapy pacemakers (CRT-P). The company simultaneously launched the devices in the U.S.

The first implant of the Ingenio pacemaker in the U.S. was performed on May 3 by Bruce L. Wilkoff, MD, director of cardiac pacing and tachyarrhythmia devices at the Cleveland Clinic, according to the company.  

Pacemakers are designed to treat bradycardia, a condition in which the heart beats too slowly—usually less than 60 beats per minute. The Ingenio and Advantio pacemakers feature RightRate pacing technology designed to treat chronotropic incompetence (CI), which is the inability of the heart to regulate its rate appropriately in response to physical activity. The Natick, Mass.-based Boston Scientific said that RightRate employs its minute ventilation sensor, which seeks to restore chronotropic competence.

In addition to RightRate, the Ingenio pacemaker offers Respiratory Rate Trend (RRT), a feature that seeks to monitor respiration. The Invive CRT-P offers RRT as part of HF Perspectiv—a suite of heart failure diagnostics.

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 may allow physicians to conduct remote follow-ups of these device patients to monitor specific pacemaker information and heart health status, according to the company. The system is designed to detect clinical events between scheduled visits and send relevant data to a physician-accessible website via landline or cellular-based telephone technology using AT &T’s wireless network, under an agreement between Boston Scientific and AT &T. 

In April, the company announced CE Mark approval and European market launch of the Ingenio and Advantio pacemakers and Invive CRT-P.