Medtronic Micra, World’s Smallest Pacemaker That Lives Inside Heart, Cleared in Europ
 

Medtronic Micra, World’s Smallest Pacemaker That Lives Inside Heart, Cleared in Europe
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Medtronic landed the CE Mark of approval to introduce its Micra pacemaker in Europe. This is the world’s smallest pacemaker, and because it’s implanted via transfemoral route completely inside the heart it doesn’t need or use cardiac leads. Moreover, there’s ** need to create a chest pocket for the pacemaker to reside in, avoiding many of the complications related to that.

http://www.medgadget.com/wp-content/...a-in-heart.jpgThe device is attached directly to the heart using tines, with the electrode at the tip delivering the pacing signals. It can be repositioned as needed, or ******* for any reason.

The Micra*has already been implanted in initial patients in the U.S., though it*is still considered an investigational device by the FDA.

From the an**uncement:

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.

Flashbacks: Medtronic Introduces Micra, World’s Smallest Pacemaker…; World’s Smallest Endocardial Pacemaker Getting Implanted in Initial Set of Patients…

Source: Medtronic…

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