Boston Scientific cardiac pacemakers win FDA approval
The US Food and Drug Administration (FDA) has granted Boston Scientific approval to market its Ingenio and Advantio pacemakers, along with Invive cardiac resynchronisation therapy pacemakers (CRT-P).
Ingenio and Advantio pacemakers feature RightRate pacing technology integrated with a minute ventilation (MV) sensor 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 the stairs.
The Ingenio family of pacemakers and CRT-Ps are designed for use 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 will also enable physicians 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 utilising AT&T's wireless network.
The Ingenio pacemaker also provides respiratory rate trend (RRT) which monitors respiration, while Invive CRT-P offers RRT as part of HF Perspective, a suite of heart failure diagnostics that provides healthcare professionals with additional information to guide treatment decisions.
Joe Fitzgerald, Boston Scientific Cardiac Rhythm Management group's senior vice president and president, said: "The company's significant investments in the Ingenio platform have been focused on long-term innovation in pacing technologies and are expected to support a comprehensive series of launches over the next few years to expand our pacing capabilities and help improve patient outcomes."
The company said that the first implant of the Ingenio pacemaker in the US was performed on 3 May 2012 at the Cleveland Clinic, US.
The Ingenio, Advantio and Invive pacemakers received CE mark approval last month.