May 11, 2015 — Medtronic plc announced it has received CE (Conformité Européenne) Mark for the Micra Transcatheter Pacing System (TPS), the world’s smallest pacemaker. At less than one-tenth the size of traditional pacemakers, the Micra device provides advanced pacing technology while being cosmetically invisible and small enough to be delivered with minimally invasive techniques through a catheter, and implanted directly into the heart.
Comparable in size to a large vitamin, 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.
“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,” said Philippe Ritter, M.D., cardiologist at Hôpital Cardiologique de Haut Lévêque and Centre Hospitalier Universitaire (CHU) Bordeaux. “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.”
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. Despite its miniaturized size, the Micra TPS has an estimated 10-year battery life and is approved for full-body magnetic resonance imaging (MRI) scans, providing patients with access to the most advanced imaging diagnostic procedures.
The device was awarded CE Mark based on results from the first 60 patients (at three months) 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, multi-center study that will enroll up to 780 patients at approximately 50 centers in 20 countries. Initial results from the trial will be revealed for the first time at a late-breaking clinical trials session at the Heart Rhythm Society’s 2015 Annual Scientific Sessions, May 13-16 in Boston.
In the U.S., the Micra TPS is an investigational device and not yet approved for commercial use.
For more information: www.medtronic.com