Medtronic, Inc. is trumpeting the first-in-human implant of the world’s smallest pacemaker, called the Micra™ Transcatheter Pacing System (TPS). The device was implanted in a patient in Linz, Austria as part of the Medtronic global pivotal clinical trial.
In recent months we’ve covered the developing story of Nanostim’s leadless mini pacemaker, newly acquired by St.Jude Medical in a $188 million deal.
Now Medtronic has popped up with its Micra TPS, designed for delivery directly into the heart through a catheter inserted in the femoral vein. Once positioned, the device is securely attached to the heart wall, although it can be repositioned if needed.
Unlike current pacemaker implant procedures, Micra TPS 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. Neither does the device require the use of 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.
The implantation was part of Medtronic’s single-arm, multi-center global clinical trial that will enroll up to 780 patients at approximately 50 centers. Initial results from the first 60 patients, followed up to three months, are expected in the second half of 2014.
“Because of its small size and unique design, the Micra TPS can be introduced directly into the heart via a minimally invasive procedure, without the need for leads,” said Clemens Steinwender, M.D., head of cardiology at the Linz General Hospital in Linz, Austria. “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.”
“Micra TPS is an example of the significant investment we have made in disruptive technology, specifically the miniaturization of implantable cardiac devices,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “Less invasive, miniature device technologies show strong promise in improving patient outcomes and implant procedure efficiency. Through our global Micra TPS clinical trial, we intend to generate robust evidence of these benefits to patients and clinicians throughout the world.”
Source: Medtronic, Inc.