CE Mark approval for Advantio/Ingenio pacemakers from Boston Scientific for Bradycardia

CE Mark approval has been given and European market launch is taking place for Ingenio and Advantio pacemakers and Invive cardiac resynchronization therapy pacemakers (CRT-P) from Boston Scientific. 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. The Ingenio and advantio pacemakers are currently under review by the FDA and are currently not available for sale in the United States.