Medtronic has reported that its Micra transcatheter pacing system (TPS) has been successfully implanted in the first patient at NYU Langone Medical Center in New York City in the US, as part of the company's single-arm, multi-centre global clinical trial.
The trial will enroll around 780 patients at approximately 50 centres and initial results from the first 60 patients, followed up to three months, are expected in the second half of 2014.
Medtronic claims it as the world’s smallest pacemaker, which is just one-tenth the size of a conventional pacemaker and is comparable in dimensions to a large vitamin.
The Micra TPS can be directly introduced into the heart through a minimally invasive procedure without the need for leads to connect to the heart.
Surgeons deliver the pacemaker through a catheter inserted into the femoral vein and it is then attached to the heart wall, though it can be repositioned if needed.
Attached to the heart through small tines, the Micra TPS delivers electrical impulses that pace the heart through an electrode at the end of the device.
The Micra TPS implant 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.
Medtronic president of the Cardiac Rhythm Disease Management business and senior vice president Pat Mackin said Micra TPS is an example of the significant investment the company has made in disruptive technology, specifically the miniaturization of implantable cardiac devices.
"Less invasive, miniature device technologies show strong promise in improving patient outcomes and implant procedure efficiency," Mackin added.
"The FDA’s interactive review with CRDM was a key part of the IDE application approval process, and through our global Micra TPS clinical trial, we intend to generate robust evidence of these benefits to patients and clinicians throughout the world."
Image: Medtronic World Headquarters – Minneapolis Photo: Courtesy of Medtronic Inc.