Medtronic
(NYSE: MDT)
announced today that it received FDA approval for its Micra AV2 and Micra VR2 leadless pacemakers.
The next-generation, miniaturized, leadless pacemakers offer longer battery life and easier programming compared to previous versions. Medtronic said they also continue to deliver the established benefits of leadless pacing, such as reduced complications compared to traditional pacemakers.
According to a news release, Medtronic Micra AV2 and VR2 bring 40% more battery life compared to previous generations. The devices have a median projected battery life of nearly 16 years (AV2) and 17 years (VR2). Medtronic said this means more than 80% of patients receiving a Micra pacemaker should only need one device for life.
The Micra AV2 also features advanced algorithms that automatically program AV synchrony. This helps to coordinate the heart’s upper and lower chambers. Additionally, AV2 has a higher available tracking capability for faster heart rates (up from 115 to 135 beats per minute for upper limits).
Medtronic likens the size of its Micra pacemakers to a multivitamin — less than one-tenth the size of traditional pacemakers. Without leads or a surgical “pocket” under the skin, the devices eliminate some potential complications, and there is no visible sign of the device.
Dr. Camille Frazier-Mills, an electrophysiologist at Duke University Health System, said improved AV synchrony and longer battery life “are major wins for patients.”
“Our goal is to improve the patient experience by continuously reinventing our ground-breaking leadless pacemaker,” said Dr. Robert C. Kowal, GM, Cardiac Pacing Therapies within the Cardiac Rhythm Management business at Medtronic. “Since inventing the first battery-operated cardiac pacemakers 65 years ago, Medtronic has transformed pacing technologies to benefit patients, including the nearly 200,000 patients globally who have received a Micra device so far.”