Leadless Pacemaker Approved by FDA

The US. Food and Drug Administration today approved the first cardiac pacemaker that does not require the use of wired leads.

The device, known as the Micra Transcatheter Pacing System works like other pacemakers to regulate heart rate.

But it is a self-contained implanted directly in the right ventricle chamber of the heart. It is about one inch long.

In announcing its approval the agency said it evaluated data from a trial of 719 patients who go the device. Ninety-eight percent of the patients had adequate heart pacing six months after the device was implanted, the FDA noted..

Complications occurred in fewer than 7 percent of participants and included prolonged hospitalizations, deep vein thrombosis, pulmonary embolism) heart injury, device dislocation and heart attacks.

The new device is made by Medtronic. It is contraindicated for patients who have implanted devices that would interfere with the pacemaker, patients who are severely obese, those who have an intolerance to materials in the device or to heparin.

Patients need to have veins that can accommodate the 7.8 mm introducer sheather and the implant.