February 20, 2014 — Medtronic Inc. announced the first U.S. implant of the Micra Transcatheter Pacing System (TPS). The device was successfully implanted at NYU Langone Medical Center by Larry Chinitz, M.D., director of the Heart Rhythm Center at NYU Langone Medical Center in New York City. The implantation is part of the Medtronic global pivotal clinical trial. The Micra TPS is an investigational device worldwide.
At one-tenth the size of a conventional pacemaker, and comparable in size to a large vitamin, the Micra TPS is delivered directly into the heart through a catheter inserted in the femoral vein. Once positioned, the pacemaker is securely attached to the heart wall and can be repositioned or retrieved if needed. The miniature device does not require the use of wires to connect to the heart. Attached to the heart via small tines, the pacemaker delivers electrical impulses that pace the heart through an electrode at the end of the device.
The Micra TPS implant does not require a surgical incision in the chest and the creation of a “pocket” under the skin. This eliminates a potential source of device-related complications, and any visible sign of the device.
The study is a single-arm, multi-center global clinical trial that will enroll up to 780 patients at approximately 50 centers. Initial results from the first 60 patients, followed up to three months, are expected in the second half of 2014.
For more information: www.medtronic.com