Medtronic announces CE Mark approval for Micra pacemaker

Micra Transcatheter Pacing System, said to be the world's Smallest Pacemaker, is less than one-tenth the size of a conventional pacemaker and is placed directly in the heart

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The Micra device provides the most advanced pacing technology available while being cosmetically invisible

Medtronic has announced that it has received the CE (Conformité Européenne) Mark for the Micra Transcatheter Pacing System (TPS), the world's smallest pacemaker.

At less than one-tenth the size of a traditional pacemaker, the Micra pacing system 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.

Comparable in size to a large vitamin, 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.

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 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 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.

 

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