The Fridley, Minn.-based medical device giant said the FDA approved its Amplia and Compia MRI Quad CRT-D SureScan devices for MRI scans on any part of the body without positioning restrictions. Medtronic plans to have the heart failure devices on the market “in the coming months,” according to a press release.
“With FDA approval of Amplia MRI and Compia MRI, Medtronic continues to lead the market in MR-conditional implantable cardiac devices, bringing greater access to patients that need this vital diagnostic test to identify other potential life-threatening diseases,” heart failure general manager Dr. David Steinhaus said in prepared remarks. “Medtronic is committed to continuing to develop innovative technologies that offer physicians a wide range of technology options to help them improve outcomes for heart failure patients.”
“What’s clear from the data and my own personal experience is that a large majority of CRT-D patients will likely need an MRI at some point. Now that CRT-D MRI devices are approved, patients can receive an MRI in a straightforward manner,” added Dr. Rod Gimbel of Case Western Reserve University. “This is a significant development for heart failure patients with CRT-D therapy.”
The approval marks the 3rd time Medtronic has been 1st to the U.S. market with a class of MRI-safe devices. In 2011 the federal safety watchdog approved its MR-conditional Revo MRI SureScan pacemaker; last year the FDA gave the green light to its Evera MRI SureScan implantable cardioverter defibrillators.