Boston Scientific has announced the CE Mark approval and European launch of its INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers (CRT-P). One main feature of the new pacemakers is their ability to adjust heart rate in response to the level of physical activity:
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 also 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 going up a flight of 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.
The INGENIO family of pacemakers and CRT-Ps is expected to be compatible with Boston Scientific’s new LATITUDE™ NXT Remote Patient Management system, which would 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.
In addition, Boston Scientific expects to launch a series of devices with expanded capabilities, including remote monitoring, advanced heart failure diagnostics and compatibility with magnetic resonance imaging systems. The INGENIO and ADVANTIO pacemakers are not yet available in the United States, but they are currently under review by the FDA.