New leadless pacemaker gets European backing

20th April 2015

Another leadless pacemaker put into the heart via a vein in the leg has gained CE Mark approval in Europe.

The Micra transcatheter pacing system from Medtronic follows the Nanostim leadless pacemaker from St Jude Medical.

The Micra, described as no bigger than a coin and a tenth of the size of traditional pacemakers, has got backing for European regulators for safety and efficacy.  Patients were fitted with the tiny device and followed up for three months.

Micra pacing system

The device, which is fully-contained, is put into the heart by a catheter. So there is no need for an incision in the chest.   It is designed to give patients with a slow heart rate advanced pacing without invasive surgery. 

The manufacturers say the device responds to the patient’s activity levels and adjusts therapy automatically. The battery is designed to last around ten years

Researchers in America are to trial the device with 780 patients in 50 hospitals.

Dr Philippe Ritter, from the Bordeaux Hospital University Centre, France, will be presenting initial study results at the Heart Rhythm Society's 2015 Scientific Sessions in May.

The two pacemakers—Micra and Nanostim—differ slightly how they are lodged in the  right ventricle’s heart muscle.