FDA approves world's smallest pacemaker that attaches directly to heart

The Food and Drug Administration (FDA) has approved a new pacemaker for the heart that doesn’t require the use of wires that can sometimes cause complications.

The inch-long device from Medtronic PLC, called Micra, uses small prongs to attach directly to the heart, where it delivers electrical pulses that help the heart beat more regularly. Older pacemaker devices are implanted under the skin near the collarbone and are hooked to the heart by one or more wires that are fed through the veins.

Those wires, sometimes called leads, can break or grow infected, causing complications and the need for extra procedures.

“As the first leadless pacemaker, Micra offers a new option for patients considering a single chamber pacemaker device, which may help prevent problems associated with the wired leads,” William Maisel, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in a statement.

The FDA said Micra is intended for patients with irregular heartbeats such as atrial fibrillation or bradycardia-tachycardia syndrome.

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