The single-arm, pivotal clinical trial will enroll up to 780 patients at approximately 50 centers. Initial results from the first 60 patients, followed up to three months, are anticipated in the second half of 2014.

Medtronic claims that the Micra TPS, an investigational device, is the world’s smallest pacemaker. The company said that its Micra system is one-tenth the size of a conventional pacemaker and is comparable in size to a large vitamin.

Micra TPS 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.

The small size and unique design of the Micra TPS allows the direct introduction of the device into the heart via a minimally invasive procedure, without the need for leads to connect to the heart.

Medtronic World Headquarters – Minneapolis

The pacemaker is attached to the heart via small tines and it 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.

Medtronic senior vice president and Cardiac Rhythm Disease Management business president Pat Mackin noted 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. Through our global Micra TPS clinical trial, we intend to generate robust evidence of these benefits to patients and clinicians throughout the world," Mackin added.

Image: Medtronic World Headquarters – Minneapolis Photo: Courtesy of Medtronic Inc.