The FDA approved Medtronic’s Micra Transcatheter Pacing System (TPS) on April 6.
The device is the first commercially available leadless intracardiac transcatheter pacing system in the U.S. The Micra is also the first transcatheter pacing system approved for 1.5 and 3 Tesla full-body MRI scans.
The approval was based on results of a single-arm study at 56 centers in 19 countries that was published in November 2015 in the New England Journal of Medicine and simultaneously presented at the American Heart Association Scientific Sessions.
The trial included 725 patients who met class I or II guideline-based indications for pacing and who were suitable candidates for single-chamber ventricular demand pacing. Patients were excluded if they had a pacemaker or implantable cardioverter-defibrillator.
After six months, 96 percent of patients had no major complications, which was significantly better than the major complications seen in patients who received conventional pacing systems. Of the patients, 1.6 percent had cardiac injuries, 0.7 percent had complications at the groin site and 0.3 percent had pacing issues.
Further, 98.3 percent of patients had low and stable pacing thresholds at six months. The projected mean longevity of the Micra was more than 12 years.