August 4, 2014 — Medtronic announced preliminary results from the first human implants of the world’s smallest pacemaker, the Micra transcatheter pacing system (TPS). Results from the first four patients to receive the Micra TPS were reported at the Cardiostim-EHRA Europace 2014 World Congress in Nice, France.
At one month and three months, results showed the Micra TPS was successfully implanted in all patients, whose ages ranged from 74 to 83 years, and there were no major complications post-implant. The device performed as expected, and electrical values were within normal ranges.
The Micra TPS is an investigational device worldwide and not approved in the United States. Its safety and efficacy is currently being evaluated in the Medtronic Micra TPS global clinical trial. The trial is a single-arm, multicenter study that will enroll up to 780 patients at approximately 50 centers.
“We are encouraged by these preliminary results and are hopeful that this less invasive procedure will provide similar outcomes for all patients in the trial,” said Clemens Steinwender, M.D., head of cardiology at the Linz General Hospital in Linz, Austria, who presented the data at Cardiostim 2014.
The miniature device does not require a surgical incision, which eliminates any visible sign of the device and a potential source of device-related complications. 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 Micra TPS does not require the use of leads to connect to the heart, and is attached via small tines which secure the Micra TPS to deliver electrical impulses that pace the heart.
For more information: www.medtronic.com