Boston Scientific has received CE mark approval to launch its Ingenio and Advantio pacemakers, along with Invive cardiac resynchronisation therapy pacemakers (CRT-P), in Europe.
Ingenio and Advantio pacemakers feature RightRate pacing technology designed to treat chronotropic incompetence (CI), an 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 stairs.
The Ingenio family of pacemakers and CRT-Ps are expected to be compatible with the company’s new Latitude NXT remote patient management system, which will enable physicians to conduct remote follow-ups to monitor specific pacemaker information and heart health status.
The Latitude patient management 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.
Boston Scientific Cardiac Rhythm Management group senior vice president and president Joe Fitzgerald said the pacemakers represent investment in long-term innovation for pacing technology and define a new era of pacing for the company.
"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 wellbeing," Fitzgerald added.
Dr. Marc Burban of Nouvelles Cliniques Nantaises in Nantes, France, said the Ingenio device enables physicians to treat pacemaker patients with an advanced and comprehensive set of therapies.
"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," Burban added.
Currently, the Ingenio and Advantio pacemakers are not available for sale in the US and are under review by the US Food and Drug Administration.