Medtronic Micra

First Vitamin-Sized Leadless Pacemaker Hits U.S. Market

By MedTech Intelligence Staff
Medtronic Micra

Medtronic wins FDA approval for the world’s smallest pacemaker.

Yesterday the Micra Transcatheter Pacing System (TPS), officially the world’s smallest pacemaker, received FDA approval. About the size of a large vitamin, the device can be implanted directly into the heart via a catheter. It is the first FDA-approved device that uses miniaturized pacing technology as well as the only TPS that is approved for 1.5 and 3 Tesla full-body MRI scans.

Medtronic Micra
The Micra TPS. (Click to enlarge) Image courtesy of Medtronic plc

“Dating back to the development of the first external battery operated pacemaker more than 60 years ago, Medtronic has a long history of collaborating with clinicians to better understand the needs of patients, and then innovating new products to meet those needs,” said John Liddicoat, M.D., senior vice president, Medtronic and president of the company’s Cardiac Rhythm and Heart Failure division in a press release. “We are thrilled to be the first to introduce a transcatheter pacemaker to patients in the U.S., and we’re looking forward to working with physicians and educating implanters to extend the positive results of our global clinical trial experience to even more patients.”

Although intended for permanent implant in the body, the Micra system includes a retrieval feature. It also has a shut-off feature that can be used if a patient needs more than one device, thus preventing electrical interaction with the new device. The leadless Micra TPS attaches to the heart, and small tines deliver electrical impulses to pace the heart via an electrode at the end of the device. The device received a CE Mark in April 2015.

Take a look at the evolution in size of Medtronic’s pacemaker technology:

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