The FDA approved the Claria MRI quad cardiac resynchronization therapy (CRT) defibrillator for patients with heart failure.
Medtronic announced the approval Nov. 14 in a news release. The company said the device is approved for scanning in 1.5 and 3 Tesla magnetic resonance imaging (MRI) machines and has a SureScan MR-conditional labeling for full-body scans without positioning restrictions.
The Claria device includes Medtronic’s EffectivCRT diagnostic to determine the effectiveness of each left ventricular pace and the EffectivCRT during atrial fibrillation algorithm that automatically adjusts pacing rates during atrial fibrillation.
Medtronic also said it had submitted pre-market approval to the FDA for multiple point pacing for use in the Claria MRI and Amplia MRI devices. Multiple point pacing is not yet FDA-approved.
In October, the FDA approved Medtronic's cardiac rhythm and heart failure devices and leads to be scanned in 1.5 and 3 Tesla MRI machines.
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.