FDA Approves First MR-Conditional CRT-D Devices

Arundhati Parmar

Medtronic announced Friday that FDA has approved the the first MR-conditional cardiac resynchronization therapy defibrillators (CRT-Ds) for the treatment of heart failure in the U.S. 

The Medtronic Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan systems are approved for MRI scans on any part of the body without any kind of positioning restrictions. The products will be launched commercially soon.

The MR-Conditional CRT-D device from Medtronic

“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 Dr. J. Rod Gimbel, Case Western Reserve University, in a Medtronic news release. “This is a significant development for heart failure patients with CRT-D therapy."

Medtronic believes as many as 40% of CRT patients will require an MRI within four years after receiving a device. 

While the approval of the two Amplia and Compia devices is the first approval of a CRT-D device that is considered compatible with MRI scans in the U.S., European patients have accessed this technology for a few years now.  

In 2012, Biotronik received CE Mark for the first CRT-D device that was MR-Conditional, according to Venice Arrhythmias. About 60 million MRI scans are performed globally every year, according to a 2008 paper.  

Arundhati Parmar is senior editor at MD+DI. Reach her at [email protected] and on Twitter @aparmarbb