The US Food and Drug Administration (FDA) has cleared Boston Scientific's Ingenio and Advantio pacemakers, and Invive cardiac resynchronization therapy pacemakers (CRT-P).
The Ingenio and Advantio pacemakers feature RightRate pacing technology embedded with minute ventilation (MV) sensor to treat chronotropic incompetence (CI).
The Ingenio pacemaker also features respiratory rate trend (RRT) which monitors respiration, while Invive CRT-P offers RRT as part of HF Perspectiv, a 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 the company’s new Latitude NXT remote patient management system, which is currently under review by the FDA.
The Latitude NXT system enables physicians to conduct remote follow-ups of the device patients, detect clinical events and send relevant data directly to a secure physician-accessible website via landline or cellular-based telephone technology using AT&T’s wireless network.
Boston Scientific cardiac rhythm management group senior vice president and president Joe Fitzgerald said, "The company’s significant investments in the INGENIO platform have been focused on long-term innovation in pacing technologies, and are expected to support a comprehensive series of launches over the next several years to expand our pacing capabilities and help improve patient outcomes."
The company said that the first implant of the Ingenio pacemaker in the US was performed on 3 May 2012 by Cleveland Clinic’s cardiac pacing and tachyarrhythmia devices director Bruce Wilkoff.