Wireless Pacemaker Gets FDA's OK

Medically Reviewed

We have wireless phones, wireless speakers, wireless keyboards—so why not wireless pacemakers? While it doesn’t operate via Wi-Fi like other wireless devices, the first pacemaker without wire leads was approved by the U.S. Food and Drug Administration in April 2016.

A traditional pacemaker, used to control heart rhythm disorders like atrial fibrillation and brady-cardia-tachycardia syndrome, is composed of a pulse generator attached to one to three wires (leads). It’s surgically implanted, usually below the collarbone, where it monitors heart rhythm and supplies electrical triggers if the heart is beating too slowly.

The leads are inserted into the heart through a large vein that runs under the collarbone. However, the leads can sometimes malfunction or cause problems that might require surgery if surrounding tissue becomes infected.

The newly approved Micra pacemaker, by Medtronic, does away with the need for leads and invasive surgery. Instead, the approximately 1-inch pacemaker, shaped like an oversized vitamin, is inserted via a small incision through a vein near the groin and threaded to the heart, where it’s implanted in the right ventricle chamber.

In a clinical trial, 98 percent of patients who received the new device had their heart rates adequately controlled six months later. About 7 percent of the patients experienced prolonged hospitalizations, blood clots in the legs and lungs, heart injury, device dislocation, and heart attacks. Some patients’ blood vessels may be too small to accommodate the device. No word yet on the device’s availability or cost.