Medtronic Announces First US Implantation of Micra Transcatheter Pacing System

February 20, 2014—Medtronic, Inc. (Minneapolis, MN) announced the first United States implantation of its Micra transcatheter pacing system (TPS), a miniature, minimally invasive pacemaker. The device was successfully implanted at NYU Langone Medical Center by Larry Chinitz, MD, Director of the Heart Rhythm Center at NYU Langone Medical Center in New York City, as part of the Micra TPS global pivotal clinical trial. 

In its press release, Medtronic noted that the Micra TPS is an investigational device worldwide. The current Micra TPS study is a single-arm, multicenter global clinical trial that will enroll up to 780 patients at approximately 50 centers. The initial results from the first 60 patients, followed up to 3 months, are expected in the second half of 2014.

At one-tenth the size of a conventional pacemaker, the Micra TPS is comparable in size to a large vitamin and 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 leads to connect to the heart. The pacemaker 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 company advised.

In contrast to current pacemaker implantation procedures, the Micra TPS implant does not require a surgical incision in the chest and the creation of a “pocket” under the skin, eliminating a potential source of device-related complications and any visible sign of the device. 

“With its small size and minimally invasive procedure, this technology represents the future of pacing,” said Dr. Chinitz. “Eliminating the need for a lead and pocket has the potential to reduce complications and recovery times compared to traditional pacemaker implants, which would be a major benefit to patients.”