FDA approves Medtronic's tiny, wireless, minimally invasive pacemaker implant

The FDA approved a new, tiny pacemaker from Medtronic that does not require the wiring of separate electrodes between the implant and the heart.

Less than one-tenth the size of traditional pacemakers and described as one of the world’s smallest, the Micra AV device is designed to be placed entirely within the heart’s right ventricle and attach itself to the muscle wall using small tines.

It is implanted via a catheter and a minimally invasive procedure—compared to its larger predecessors that are typically embedded under the skin near the collarbone and connected to the organ with electric leads—which Medtronic says opens up pacemaker treatment options to patients who would otherwise not undergo the procedure. 

The system is based on the medtech giant’s previously approved Micra transcatheter pacing system for treating bradyarrhythmia. While identical in size and shape, the Micra AV is built for patients with atrioventricular block, which occurs when electrical signals from the heart’s upper atria have trouble reaching its lower, pumping ventricles.

The new device also includes internal sensing algorithms and accelerometers that detect the movement of the muscle with each heartbeat and allow it to adjust its electrical pacing and synchronize with the heart’s chambers.

“The introduction of Micra AV reinvents our own innovation, bringing the many benefits of leadless pacemakers to more patients,” said Rob Kowal, chief medical officer and vice president of medical affairs for Medtronic’s cardiac rhythm and heart failure division. 

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The company said it will begin training field personnel and physicians, with plans to launch the device at a limited number of centers in the coming weeks before a full rollout in the spring.

The Micra AV’s approval was based on a clinical study evaluating its motion-based sensing algorithms and their ability to detect atrial contractions and coordinate pacing, where 95% of patients demonstrated 70% or greater atrioventricular synchrony with the treatment.

In addition, previous studies of the Micra system showed implant success rates greater than 99%, with 63% fewer major complications than traditional pacemakers, according to Medtronic.