Medtronic plc has announced that it has received CE Mark of the Micra Transcatheter Pacing System (TPS), one of the world’s smallest pacemakers.
According to a company release, at less than one-tenth the size of traditional pacemakers, the Micra device provides the most advanced pacing technology available while being cosmetically invisible and small enough to be delivered with minimally invasive techniques through a catheter, and implanted directly into the heart.
Micra do not have lead wires, and is implanted into the heart through a catheter. Eliminating leads is a good thing for patients, since lead migration and the potential need for extraction can lead to complications.
“Unlike traditional pacemakers, the Micra TPS does not require leads or a surgical ‘pocket’ under the skin, so potential sources of complications are eliminated – as are any visible signs of the device,” said Philippe Ritter, MD, cardiologist at Hôpital Cardiologique de Haut Lévêque and Centre Hospitalier Universitaire (CHU) Bordeaux.
The device was awarded CE Mark based on results from the first 60 patients (at three months) in the Medtronic Micra TPS Global Clinical Trial. The trial is ongoing and will continue to evaluate the safety and efficacy of the device through a single-arm, multi-centre study that will enroll up to 780 patients at approximately 50 centres in 20 countries. Initial results from the Micra TPS Global Clinical Trial will be revealed for the first time at a late-breaking clinical trials session at the Heart Rhythm Society’s 2015 Annual Scientific Sessions in May.
“Our cross-functional teams have been working for years to redefine engineering limits and production capabilities by radically reducing the size of medical devices by more than 90 per cent while continuing to innovate upon the existing technology,” said Brian Urke, vice president and general manager of the Cardiac Rhythm and Heart Failure’s Brady business, which is part of the Cardiac and Vascular Group at Medtronic. “We believe our investment in this research is transforming cardiac care and will provide more and better therapy options to patients.”