Boston Scientific received FDA approval and is releasing in the U.S. the INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers (CRT-P).
The devices are indicated for treatment of bradycardia, and the INGENIO and ADVANTIO pacemakers specifically feature BostonSci’s RightRate technology for addressing chronotropic incompetence, a condition in which the heart is unable to regulate its rate appropriately in response to physiologic stress, such as an exercise.
More from the announcement:
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.
In addition to RightRate, the INGENIO pacemaker offers Respiratory Rate Trend (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. The system is designed to detect clinical events between scheduled visits and send relevant data directly to a secure 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.