Medtronic announced U.S. Food and Drug Administration (FDA) clearance of the world’s smallest pacemaker this week, which encompassed a series of design changes:
- The Medtronic Micra Transcatheter Pacing System (TPS) can be implanted into the heart’s lower-right chamber by catheter and replaces leads, often the source of complications, with “small tines” that deliver “electrical impulses that pace the heart through an electrode at the end of the device.”
- Since the pill-sized implant is inserted into the heart, patients do not need the surgical pocket under the skin for the pacemaker, which has also been a source of complications, such as infection.
- It is the only transcatheter pacing system approved for 1.5 and 3 Tasla full-body MRI scans.
- When patients no longer need the device, it can be completely shut off or removed if necessary.
The clinical trials for the device were published in the November 2015 New England Journal of Medicine. “In the clinical trial, the Micra was successfully implanted in nearly all patients, and met its safety and effectiveness endpoints by wide margins. This gives us great confidence that this miniaturized device will bring patients the most advanced pacing technology, combined with the less-invasive nature of the new technology,” said Dwight Reynolds, M.D., regent’s professor and chief of the Cardiovascular Section at the University of Oklahoma Health Sciences Center, and principal investigator in the Micra TPS Global Clinical Trial, in a press release.