Medtronic's leadless cardiac pacemaker is approved by the US FDA

The US Food and Drug Administration approved a new type of pacemaker developed by Medtronic that does not require wires.

Radiographic cardiac pacemakers approved by the FDA

The 1-inch device, called Micra, uses a small pointed tip to mount directly on the heart, and then sends an electrical pulse to help the heart beat more regularly.

An old cardiac pacemaker is implanted under the skin of the patient's clavicle and hooked through the vein through one or more wires. These wires can sometimes cause complications.

William Maisel, Acting Director of the Equipment Evaluation Office of the FDA's Equipment and Radiation Health Center, said: "As the first leadless cardiac pacemaker, Micra offers patients new options and may help prevent wire-related problems."

The US FDA pointed out that Micra is suitable for patients with irregular heartbeat such as atrial fibrillation or bradycardia-tachycardia syndrome.

According to clinical trials published by Medtronic in the New England Journal of Medicine last year, a total of 725 patients were implanted with Micra, and after 6 months, approximately 98% of patients had normal heartbeat. The report showed that 25 patients had serious complications such as heart damage and blood clots.

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