FDA Clears New Boston Scientific Devices to Treat Bradycardia
The Ingenio and Advantio pacemakers 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 climbing 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 timesavings.
In addition to RightRate, the Ingenio pacemaker offers Respiratory Rate Trend (RRT), an exclusive feature that monitors respiration. The Invive CRT-P offers RRT as part of HF Perspectiv – a comprehensive suite of heart failure diagnostics designed to provide healthcare 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 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. The company received U.S. Food and Drug Administration (FDA) approval in May 2012.
For more information: www.bostonscientific.com