FDA approves Medtronic's Micra, first wireless pacemaker in the U.S.
- The FDA on Wednesday approved Medtronic's Micra pacemaker device, the first pacemaker which doesn't require wired leads to transmit electrical signals to the heart.
- Micra is implanted into the right ventricle chamber of the heart, directly transmitting electrical pulses to regulate heart rate. Until now, pacemakers have used wires running through a vein into the ventricle. However, these wires can break or lead to infection.
- The device will be allowed for use in patients with atrial fibrillation, bradycardia syndrome, or other arrhythmias.
The clinical data used to support the approval includes a six-month study of 725 patients, all of whom were implanted with Micra. At the six-month mark, 98% of the patients had adequate heart pacing, although 25 patients experienced major complications, including clots.
"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, the principal investigator for the Micra trial.
Since there was no control group in the six-month study, researchers did a study comparing the rate of complications in Micra patients with patients in other studies who were implanted with older pacemakers. According to the researchers, the Micra pacemaker device was associated with significantly fewer complications, reports the Wall Street Journal.
Micra is a single-chamber pacemaker, so it is contraindicated for patients who require dual-chamber support, such as patients with heart failure. However, Medtronic is currently working on different types of lead-less pacemakers, which will serve a larger cross-section of patients who need cardiovascular pacing support.
- Wall Street Journal FDA Approves Medtronic Pacemaker That Attaches Directly to Heart