FDA Approves First Leadless Pacemaker

The FDA has approved the first leadless pacemaker: Medtronic’s Micra Transcatheter Pacing System.

The device is intended for patients with atrial fibrillation or other dangerous arrhythmias, such as bradycardia-tachycardia syndrome.

The FDA based its decision on data from a clinical trial that evaluated the device in 719 patients. Around 98% of patients showed adequate heart pacing 6 months after the device was implanted.

Complications occurred in fewer than 7% of the patients. Some of the events included prolonged hospitalizations, deep vein thrombosis, pulmonary embolism, heart injury, device dislocation, and heart attack.

The device is contraindicated for patients who have implanted devices that would interfere with the pacemaker, obese patients, those with an intolerance to materials in the device or heparin, or patients who have veins that are unable to accommodate the 7.8 mm introducer sheath or pacemaker implant.

“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,” said William Maisel, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, in a press release.

The device is implanted directly into the right ventricle chamber of the heart. Typically, the leads in a pacemaker run from the pacemaker through a vein into the heart's right ventricle.

The leads deliver electric pulses and help coordinate timing of the chamber’s contractions. The FDA pointed out, however, that these leads can malfunction or cause problems when infections develop in the tissue.

Nearly 1 million people have pacemakers implanted per year, according to the FDA.