Medtronic is introducing the world's smallest pacemaker after receiving the CE (Conformité Européenne) Mark, according to a company press release.
Comparable in size to a large vitamin, the Micra device provides the most advanced pacing technology available while being cosmetically invisible and small enough to be delivered with minimally invasive techniques through a catheter, and implanted directly into the heart.
"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 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."
The Micra TPS does not require the use of wires, known as "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.
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 Micra TPS Global Clinical 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 in May.
In the U.S., the Micra TPS is an investigational device and not yet approved for commercial use.