Medtronic, Inc. has announced preliminary results from the first human implants of the world's smallest pacemaker, the Micra(TM) Transcatheter Pacing System (TPS). Results from the first four patients to receive the Micra TPS were reported at CARDIOSTIM / EHRA EUROPACE 2014, World Congress in Electrophysiology and Cardiac Techniques, in Nice, France.
At 1 month and 3 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 U.S., and its safety and efficacy is currently being evaluated in the Medtronic Micra Transcatheter Pacing System (TPS) Global Clinical Trial. The Trial is a single-arm, multi-center 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 or the creation of a "pocket" under the skin, 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 wires, known as "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.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.