CE Mark Approved for Medtronic's Micra Transcatheter Pacing System

April 14, 2015—Medtronic plc announced it has received European CE Mark approval of the Micra transcatheter pacing system (TPS). 

The company advised that the approval was supported by 3-month results from the first 60 patients in the Medtronic Micra TPS global clinical trial. The trial is ongoing and will continue to evaluate the safety and efficacy of the device through a single-arm, multicenter study that will enroll up to 780 patients at approximately 50 centers in 20 countries. Initial results from the trial will be presented at a late-breaking clinical trials session at the Heart Rhythm Society’s 2015 annual scientific sessions on May 13–16 in Boston, Massachusetts.

In the United States, the Micra TPS is an investigational device and not yet approved for commercial use.

According to the company, the Micra device provides advanced pacing technology and, at less than one-tenth the size of traditional pacemakers, it is cosmetically invisible and small enough to be delivered through a catheter, and implanted directly into the heart. The Micra TPS does not require the use of leads to deliver pacing therapy; rather, it is attached to the heart via small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device.

Once positioned, the Micra TPS is attached to the heart wall and can be repositioned or retrieved, if needed. The device responds to patients’ activity levels by automatically adjusting therapy. The Micra TPS has an estimated 10-year battery life and is approved for full body magnetic resonance imaging scans, stated Medtronic.

In the company’s press release, Philippe Ritter, MD, commented, “Unlike traditional pacemakers, the Micra TPS does not require leads or a surgical ‘pocket’ under the skin, so potential sources of complications are eliminated—as are any visible signs of the device. While the Micra TPS is dramatically smaller, it is a fully self-contained pacemaker that still delivers the most advanced pacing technology available to patients.” Dr. Ritter is a cardiologist at Hôpital Cardiologique de Haut Lévêque and Centre Hospitalier Universitaire Bordeaux in France.