June 15, 2020
Medtronic Receives CE Mark Approval for Micra AV Transcatheter Pacing System
June 15, 2020—Medtronic announced it has received European CE Mark approval for Micra AV transcatheter pacing system (TPS) with atrioventricular (AV) synchrony. The Micra AV leadless pacemaker is indicated for the treatment of patients with AV block. In January, the company announced FDA approval of the device.
According to the company, CE Mark approval of the Micra AV is based on data from the MARVEL 2 study, which evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms. The study evaluated the ability of the Micra’s internal sensor to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle, thereby providing AV synchrony.
In November 2019, Medtronic announced the publication of the MARVEL 2 results by Clemens Steinwender, MD, et al in Journal of the American College of Cardiology: Clinical Electrophysiology (2020;6:94-106). The findings were simultaneously presented at AHA 2019, the American Heart Association scientific sessions held November 16–18 in Philadelphia, Pennsylvania.
MARVEL 2 showed the primary efficacy objective was met, with a significantly greater percentage of complete heart block patients with normal sinus rhythm having > 70% AV synchrony during algorithm-mediated AV synchronous pacing (38 of 40 patients, 95%) than VVI pacing (0 patients; P < .001 for the proportion of patients with > 70% synchrony). The study’s primary safety objective was also met, with no pauses or episodes of pacing-induced tachycardia reported during algorithm mediated AV synchronous pacing.
Professor José Ramón González Juanatey, MD, performed the first implants of the device at the University Hospital in Santiago de Compostela, Spain.
“This new device not only stimulates but is also able to recognize the electrical activity of the whole heart,” commented Professor González Juanatey in the company's press release. “Our ultimate goal is to bring the latest cardiovascular innovation to patients in our area. Now we can extend this wireless technology to other patients who require dual-chamber stimulation and in whom traditional stimulation cannot be performed or is conditioned by previous infections, occlusions of the vessels of the upper extremities, etc.” Professor González Juanatey is Director, Cardiology and Intensive Cardiac Care Department, and full professor of Cardiology at University Hospital, Santiago de Compostela. He is Past President of the Spanish Society of Cardiology.