US-based Medtronic has announced that its Micra transcatheter pacing system (TPS) has been implanted in the first patient in Linz, Austria, as part of the company's single-arm, multi-centre global clinical trial.
The trial will enrol 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.
The Micra TPS is just one-tenth the size of a conventional pacemaker and is comparable in dimensions to a large vitamin. Medtronic claims that the Micra TPS is the world's smallest pacemaker
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.
It 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 if required.
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.
Micra TPS implant do 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 senior vice-president Pat Mackin said Micra TPS is an example of the significant investment the company has made in disruptive technology, specifically the miniaturisation of implantable cardiac devices.
"Less invasive, miniature device technologies show strong promise in improving patient outcomes and implant procedure efficiency," Mackin said. "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 headquarters in Minneapolis, US. Photo: courtesy of Medtronic Inc.