Medtronic announces first US implant of world’s smallest, minimally invasive cardiac pacemaker


Medtronic announced the first US implant of the world’s smallest pacemaker: the Micra transcatheter pacing system. The device was successfully implanted at New York University (NYU) Langone Medical Centre by Larry Chinitz, director of the Heart Rhythm Centre at NYU Langone Medical Centre in New York City, as part of the Medtronic global pivotal clinical trial. The Micra transcatheter pacing system is an investigational device worldwide.

According to a press release, at one-tenth the size of a conventional pacemaker, and comparable in size to a large vitamin, the Micra transcatheter pacing system 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, known as “leads”, 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.

“With its small size and minimally invasive procedure, this technology represents the future of pacing,” says 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.”

In contrast to current pacemaker implant procedures, the Micra transcatheter pacing system 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 press release reports.

Medtronic has also announced the enrolment of the first US patients in the Micra transcatheter pacing system study. According to the press release, the study is a single-arm, multicentre global clinical trial that will enrol up to 780 patients at approximately 50 centres. Initial results from the first 60 patients, followed up to three months, are expected in the second half of 2014.