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, states Medtronic. 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.