Medtronic receives FDA approval for latest Micra pacemakers

Medtronic has received US Food and Drug Administration (FDA) approval for its Micra AV2 and Micra VR2, the next generation of its miniaturized, lead-free pacemakers.

The Micra AV2 and Micra VR2 offer longer battery life and easier programming than older Micra pacemakers, while still providing many of the benefits of leadless pacing, such as fewer complications.

With approximately 40% more battery life than previous generations, the Micra AV2 and Micra VR2 have an average expected battery life of approximately 16 and 17 years, respectively. This means that more than 80% of patients taking Micra are projected to need only one device for life.

The new Micra AV2 also features advanced algorithms that automatically program AV synchrony, allowing the upper and lower chambers of the heart to coordinate. In addition, for active patients, the Micra AV2 has higher available tracking capability for faster heart rates (an increase from 115 to 135 beats per minute for the upper limit).

Camille Frazier-Mills, MD, MHS, an electrophysiologist at Duke University Health System, said: “Improved AV synchrony — requiring less in-office reprogramming thanks to algorithmic optimizations — and longer battery life are major wins for patients. I am excited to introduce the new Micra device to our patients. This best-in-class technology transforms the patient experience by eliminating out-of-pocket complications, and now reduces the likelihood that patients will need to be hospitalized in the future. You will need to replace your equipment.

Robert C. Koval, MD, PhD, general manager, Cardiac Pacing Therapies, part of the cardiovascular portfolio at Medtronic, said: “Our goal is to improve the patient experience by continually refining our ground-breaking leadless pacemaker,” said Robert C. Koval, MD, PhD. Koval, MD, PhD, general manager, Cardiac Pacing Therapies within the Cardiac Rhythm Management business, which is part of the cardiovascular portfolio at Medtronic. “Since inventing the first battery-powered cardiac pacemaker 65 years ago, Medtronic has transformed pacing technologies to benefit patients, including the nearly 200,000 patients globally who have received a Micra device to date “

Micro pacemakers are less than one-tenth the size of conventional pacemakers. Micra pacemakers do not require leads or surgical “pockets” under the skin, so potential sources of complications related to leads and pockets are eliminated, and there is no visible indication of the device.