Boston Scientific gets FDA approval for new devices to treat bradycardia


Boston Scientific has announced FDA approval and market launch of its Ingenio and Advantio pacemakers and Invive cardiac resynchronisation therapy pacemakers (CRT-P).

The first implant of the Ingenio pacemaker in the USA was performed on 3 May by Bruce L Wilkoff, director of Cardiac Pacing and Tachyarrhythmia Devices at the Cleveland Clinic.

The Ingenio and Advantio pacemakers feature RightRate pacing technology designed to treat chronotropic incompetence. RightRate employs Boston Scientific’s minute ventilation sensor, according to a company release, this is the only sensor clinically proven to restore chronotropic competence, and adds programming options to promote ease of use and in-clinic time savings.

“Matching the patient’s need to increase their heart rate with their precise activities is the main goal of cardiac pacing,” said Wilkoff, who also serves as the president of the Heart Rhythm Society, and has authored numerous articles on chronotropic response and rate adaptive pacing. “Achieving that match depends on having the right tools such as a minute ventilation sensor and intelligent programming.”

“We are very pleased to receive FDA approval for these advanced devices, and excited about the potential they bring to our bradycardia business. With these products, Boston Scientific embarks on a new era in pacing technology,” said Joe Fitzgerald, senior vice president and president of the Boston Scientific Cardiac Rhythm Management group.

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.