Sam Brusco, Associate Editor01.05.24
Medtronic announced that it received CE Mark approval for its Micra AV2 and VR2 miniature, leadless pacemakers.
Heralded as “the world’s smallest pacemakers,” the company said the next-gen Micra devices have about 40% longer battery life and easier programming compared to the first-gen devices. Medtronic projects their battery life to be almost 16 and 17 years, respectively.
"For more than eight years, our Micra leadless pacemakers have provided meaningful benefits to people in Europe who require a pacemaker. Now, these patients have access to the latest leadless pacing technology that, for most of them, may be the only device they will ever need," said Robert C. Kowal, MD, Ph.D., general manager, Cardiac Pacing Therapies for Medtronic’s Cardiac Rhythm Management business.
This CE mark milestone follows U.S. Food and Drug Administration (FDA) approval for Micra AV2 and VR2 devices in 2023.
Approximately the size of a large vitamin, Micra pacemakers under one-tenth the size of traditional pacemakers. They don’t require leads or a surgical "pocket" under the skin, removing potential sources of complications. Medtronic said there is no visible sign of the device.
Heralded as “the world’s smallest pacemakers,” the company said the next-gen Micra devices have about 40% longer battery life and easier programming compared to the first-gen devices. Medtronic projects their battery life to be almost 16 and 17 years, respectively.
"For more than eight years, our Micra leadless pacemakers have provided meaningful benefits to people in Europe who require a pacemaker. Now, these patients have access to the latest leadless pacing technology that, for most of them, may be the only device they will ever need," said Robert C. Kowal, MD, Ph.D., general manager, Cardiac Pacing Therapies for Medtronic’s Cardiac Rhythm Management business.
This CE mark milestone follows U.S. Food and Drug Administration (FDA) approval for Micra AV2 and VR2 devices in 2023.
Approximately the size of a large vitamin, Micra pacemakers under one-tenth the size of traditional pacemakers. They don’t require leads or a surgical "pocket" under the skin, removing potential sources of complications. Medtronic said there is no visible sign of the device.