Medtronic PLC announced on Tuesday that it has received U.S. Food and Drug Administration (FDA) approval of the world’s smallest pacemaker, the Medtronic Micra Transcatheter Pacing System (TPS). The Micra TPS is the first FDA-approved product with miniaturized pacing technology. It is cosmetically invisible and small enough to be delivered through a catheter and implanted directly into the heart — providing a safe alternative to conventional pacemakers without the complications associated with cardiac wires (leads).

“For many years we’ve been hopeful that a transcatheter pacing solution – with a safety and effectiveness profile on par with conventional devices – would become available, and today Micra has achieved this milestone,” said Dwight Reynolds, M.D., regent’s professor and chief of the Cardiovascular Section at the University of Oklahoma Health Sciences Center, and principal investigator in the Micra TPS Global Clinical Trial. “In the clinical trial, the Micra was successfully implanted in nearly all patients, and met its safety and effectiveness endpoints by wide margins. This gives us great confidence that this miniaturized device will bring patients the most advanced pacing technology, combined with the less-invasive nature of the new technology.”

Comparable in size to a large vitamin, the Micra TPS is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. Unlike traditional pacemakers, the Micra TPS does not require leads or a surgical “pocket” under the skin, so potential sources of complications related to such leads and pocket are eliminated—as are any visible signs of the device. The device responds to patients’ activity levels by automatically adjusting therapy.

Micra TPS is the first and only transcatheter pacing system to be approved for both 1.5 and 3 Tesla (T) full-body magnetic resonance imaging (MRI) scans, providing patients with access to the most advanced imaging diagnostic procedures available.

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