CE Mark For Boston Scientific’s New Pacemakers

“The new RightRate pacing is easy to optimise and is designed to provide needed heart rates for patients to help them feel less fatigued during physical activity.”

In short

Boston Scientific Corporation has announced a flurry of CE Mark approvals and European market launches. Its INGENIO™ and ADVANTIO™ pacemakers and INVIVE™ cardiac resynchronization therapy pacemakers (CRT-P) are now cleared for take-off in the EU.

Background

According to a company press release, 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 going up a flight of stairs. RightRate employs Boston Scientific’s minute ventilation (MV) sensor, which it claims is the only sensor clinically proven to restore chronotropic competence, and adds programming options to promote ease of use and in-clinic time savings.

Telehealth potential

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.

Clinician comments

One of the first implants of the INGENIO pacemaker occurred last week by Marc Burban, M.D., at the Nouvelles Cliniques Nantaises in Nantes, France.

“The INGENIO device enables physicians to treat pacemaker patients with an advanced and comprehensive set of therapies,” said Dr. Burban. “The new RightRate pacing is easy to optimise and is designed to provide needed heart rates for patients to help them feel less fatigued during physical activity.”

Company comments

“The INGENIO family of pacemakers represents a significant investment in long-term innovation for pacing technologies and defines a new era of pacing for our company,” said Joe Fitzgerald, senior vice president and president of the Boston Scientific Cardiac Rhythm Management group. “In addition, we expect to launch a series of devices with expanded capabilities, that would include remote monitoring, advanced heart failure diagnostics and compatibility with magnetic resonance imaging systems – all designed to provide innovative new features for patient health and well-being.”

Regulatory status

The INGENIO and ADVANTIO pacemakers are currently under review by the U.S. Food and Drug Administration, and are currently not available for sale in the United States.

Source: Boston Scientific, PR Newswire