FDA approves the Micra miniature leadless pacing system
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.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.