US-based Medtronic has reported preliminary results from the first human implants of its Micra transcatheter pacing system (TPS).
An investigational device worldwide, Micra TPS was implanted in four patients whose ages ranged from 74 to 83 years.
At one month and three months, results showed that the minimally invasive cardiac pacemaker was successfully implanted in all patients and there were no major complications post-implant.
According to Medtronic, the miniature transcatheter pacemaker system performed as expected and electrical values were within normal ranges.
Medtronic is currently evaluating the safety and efficacy of the Micra TPS in its Micra TPS global clinical trial. The single-arm trial will enroll up to 780 patients at approximately 50 centres.
Medtronic claims that Micra TPS is one-tenth the size of a conventional pacemaker and 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 needed.
The Micra TPS implant does not require a surgical incision in the chest or creating a pocket under the skin, eliminating a potential source of device-related complications and any visible signs of the device.
The miniature device does not require the use of leads to connect to the heart, and is attached through mall tines, which secure the Micra TPS to deliver electrical impulses that pace the heart.
Medtronic has announced the preliminary outcomes from the first four patients who received the Micra TPS at Cardiostim / EHRA Europace 2014, World Congress in Electrophysiology and Cardiac Techniques, in Nice, France.
Image: Medtronic world headquarters in Minneapolis, US. Photo: courtesy of Medtronic, Inc.