The FDA has approved the first pacemaker that does not require wired leads to generate the electrical impulses needed to treat arrhythmia disorders, according to press releases from the agency and Medtronic.
The leadless pacemaker (Micra Transcatheter Pacing System, Medtronic), is a self-contained, 1-in. device implanted in the right ventricle, according to the releases.
“As the first leadless pacemaker, Micra offers a new option for patients considering a single-chamber pacemaker device, which may help prevent problems associated with the wired leads,” said William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health in the FDA press release.
The approval was based on data from a global clinical trial in which 719 patients were implanted with the Micra device, in which 98% percent of the patients experienced adequate pacing capture threshold 6 months after implantation and fewer than 7% experienced complications. Complications included prolonged hospitalization, deep vein and pulmonary thrombosis, heart injury, device dislocation and MI.
“In the clinical trial, the Micra was successfully implanted in nearly all patients, and met its safety and effectiveness endpoints by wide margins,” Dwight Reynolds, MD, regent’s professor and chief of the cardiovascular section at the University of Oklahoma Health Sciences Center, who was principal investigator of the trial, said in the Medtronic release. “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.”
The device is intended for patients with atrial fibrillation and other arrhythmias such as bradycardia-tachycardia syndrome, but is not suitable for patients who have implanted devices that would interfere with the pacemaker, those who are severely obese, or those who have veins that cannot accommodate the 7.8-mm introducer sheath or pacemaker implant, according to the FDA press release.
Disclosures: Maisel is an employee of the FDA. Reynolds reports consulting for Medtronic.