FDA OKs First Wireless Pacemaker

Medtronic won approval for Micra Transcatheter Pacing System to treat heart rhythm disorders

(RxWiki News) The US Food and Drug Administration (FDA) has approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart.

The Micra Transcatheter Pacing System, manufactured by Medtronic, is a self-contained, one-inch device that is implanted into the right ventricle chamber of the heart and works like other pacemakers to regulate heart rate.

Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats. Nearly 1 million people worldwide are implanted with pacemakers each year, according to the FDA.

The leads in a traditional, single-chamber pacemaker run from the pacemaker — implanted under the skin near the collarbone — through a vein directly into the heart’s right ventricle; the leads deliver electric pulses from the generator to the right ventricle and help coordinate timing of the chamber’s contractions.

But Micra eliminates these leads, which can sometimes malfunction or cause problems when infections develop in the surrounding tissue, requiring a surgical procedure to replace the device.

Micra is intended for patients with a heart arrhythmia called atrial fibrillation or those who have other dangerous arrhythmias, such as bradycardia-tachycardia syndrome.

Micra should not be used in patients who are severely obese, who have implanted devices that might interfere with the pacemaker, or who cannot tolerate materials in the device or the blood thinner heparin.