The FDA approved the Amplia and Compia MRI Quad cardiac resynchronization therapy defibrillator (CRT-D) SureScan devices for heart failure patients, manufacturer Medtronic announced on Friday morning.
Both devices are the first CRT-Ds approved that will be safe with subsequent MRI scanning throughout the body. Cardiac resynchronization therapy had previously been contraindicated for MRI scanning due to a possible interaction between the devices.
"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," said J. Rod Gimbel, MD, of Case Western Reserve University in Cleveland, Ohio, in a press release. "This is a significant development for heart failure patients with CRT-D therapy."
With quadripolar technology, the Amplia and Complia offer more ways to position cardiac stimulation over their bipolar predecessors, lowering the incidence of adverse events, Medtronic said. They also feature the AdaptivCRT algorithm, which has reduced 30-day readmissions by 46% compared with conventional, echocardiography-optimized settings.
The latest development signals that the federal agency is catching up to to the waves of safety data in favor of MRI-ready cardiac devices.
Medtronic had also been the first to get FDA approval for two other MRI-safe products: the Evera implantable cardioverter device last September, and the Revo pacemaker in 2011.