Ireland-based Medtronic has received CE mark approval for its Micra Transcatheter Pacing System (TPS), claimed to be the world's smallest pacemaker.
The Micra TPS does not require the use of wires called leads to provide pacing therapy and it is attached to the heart through small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device.
Medtronic Cardiac Rhythm and Heart Failure Brady business general manager and vice-president Brian Urke said: "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.
"We believe our investment in this research is transforming cardiac care and will provide more and better therapy options to patients."
Similar in size to a large vitamin, the Micra TPS will be attached to the heart wall once positioned and can be repositioned or retrieved, if required. It responds to patients’ activity levels by automatically adjusting therapy.
The approval was 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 assess the safety and efficacy of the device through a single-arm and multi-center study, which will enroll up to 780 patients at around 50 centers in 20 countries.
The Micra TPS is an investigational device and not yet received approval for commercial use in the US.