Medtronic logo updatedMedtronic (NYSE:MDT) announced today that it received CE Mark approval in Europe for its Micra AV transcatheter pacing system (TPS).

The Fridley, Minn.-based medtech giant touts its Micra AV as the world’s smallest pacemaker with atrioventricular (AV) synchrony. The system is indicated for treating patients with AV block, adding to its CE Mark-approved leadless pacemaker portfolio.

Dr. José Ramón González Juanatey of the University Hospital in Santiago de Compostela, Spain, performed the first implants of Micra AV, according to a news release.

“This new device not only stimulates but is also able to recognize the electrical activity of the whole heart,” Juanetey said in the 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.”

Micra AV includes internal atrial sensing algorithms to detect cardiac movement, allowing the device to adjust pacing in the ventricle to coordinate with the atrium, offering AV-synchronous pacing therapy for patients with AV block.

Medtronic’s Marvel 2 study evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms. Results, presented at the American Heart Association 2019 Scientific Sessions and published in JACC: Clinical Electrophysiology, showed that the device met its primary efficacy objective, with a 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<0.001 for proportion of patients with >70% synchrony).

The study also met its primary safety objective, experiencing no pauses or episodes of pacing-induced tachycardia during algorithm-mediated AV-synchronous pacing.

“From the first battery-operated external pacemaker in 1957 to the innovative Micra leadless pacemaker portfolio, Medtronic continues to provide pioneering pacing solutions to physicians and their patients,” Medtronic medical director for Europe, the Middle East & Africa Dr. Alphons Vincent said.