Medtronic Wins EU Approval for Leadless Pacemaker

The approval comes a year and a half after St. Jude Medical acquired Nanostim and its EU-approved leadless pacemaker.

Medtronic announced this week that it has received CE Mark of its Micra Transcatheter Pacing System, which it touts as the world's smallest pacemaker.

The Micra is less than one-tenth the size of traditional pacemakers, and a bit smaller than St. Jude Medical’s Nanostim leadless pacemaker that has been approved in the European Union since late 2013.

Both the Medtronic and Nanostim devices forgo running leads to the heart, avoiding problems such as infection. The devices both have long battery life—10 years for the Micra and 13 years for Nanostim.

"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," Philippe Ritter, MD, cardiologist at Hôpital Cardiologique de Haut Lévêque and Centre Hospitalier Universitaire (CHU) Bordeaux, said in a Medtronic news release.

"While the Micra TPS is dramatically smaller, it is a fully self-contained pacemaker that still delivers the most advanced pacing technology available to patients,” Ritter said.

The EU approval for the Micra came after results from the first 60 patients (at three months) in the Medtronic Micra TPS Global Clinical Trial.

In the U.S., the Micra TPS is an investigational device and not yet approved for commercial use. St. Jude Medical is presently in the process of seeking FDA approval for the Nanostim pacemaker.

Check out a this Qmed/MPMN story that details the development of the two devices. Medtronic took a more unusual approach to developing the Micra because it was a systematic, in-house effort. St. Jude meanwhile acquired the technology of a young company, Nanostim (run by Drew Hoffmann, a former St. Jude executive), that had innovative technology.

"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% 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."