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Medtronic initiates human trial of small, minimally invasive pacemaker

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Medtronic Inc. recently announced the first human implantation of the Micra transcatheter pacing system as part of a global pivotal trial.

The single-arm, multicenter study will include as many as 780 patients across approximately 50 facilities. Data on the first 60 recipients, after up to 3 months of follow-up, are projected for the second half of 2014.

The first implantation occurred in Linz, Austria. “The Micra TPS can be introduced directly into the heart via a minimally invasive procedure, without the need for leads,” Clemens Steinwender, MD, head of cardiology at Linz General Hospital, said in a press release. “The combination of this novel technology with a transcatheter procedure can benefit patients by potentially reducing pocket or lead complications and recovery times observed with traditional surgical pacemaker implants.”

The Micra TPS is approximately one-tenth the size of a standard pacemaker and is introduced via a catheter in the femoral vein, directly into the heart, without the need for a chest incision or a “pocket” created under the skin. The device attaches to the heart with tines and administers electrical pulses through an electrode. Besides the potential reduction in complications, there also is no visible sign of the device.

“Less invasive, miniature device technologies show strong promise in improving patient outcomes and implant procedure efficiency,” Pat Mackin, senior vice president at Medtronic, said in the release. “Through our global Micra TPS clinical trial, we intend to generate robust evidence of these benefits to patients and clinicians throughout the world.”