CE mark follows FDA approval for both devices in May of last year.
The pacemakers — which Medtronic labels as the world’s smallest — provide longer battery life and easier programming than earlier versions. Micra AV2 and Micra VR2 offer approximately 40% more battery life than previous generations. Medtronic projects battery life of nearly 16 and 17 years, respectively, for the devices.
Still, they deliver the benefits of leadless pacing like reduced complications compared to traditional pacemakers, Medtronic says. According to a news release, more than 80% of patients who receive a Micra may only require one device for life.
Micra devices also offer remote monitoring capabilities, potentially reducing hospitalizations and increasing the patient’s sense of security.
The devices register at less than one-tenth the size of traditional pacemakers. Unlike those traditional devices, the Micra devices eliminate the need for leads or a surgical “pocket” under the skin. This cuts out potential sources of complications related to leads and pockets, plus there is no visible sign of the device.
“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 Dr. Robert C. Kowal, GM of Cardiac Pacing Therapies at Medtronic.
