FDA approves Medtronic's MRI conditional CRT defibrillators for heart failure patients

The FDA has approved the first MRI conditional cardiac resynchronization therapy defibrillators (CRT-Ds) to treat patients with heart failure and reduce the risk of sudden cardiac arrest.

The devices, both from Medtronic, are the Amplia MRI Quad CRT-D SureScan and the Compia MRI Quad CRT-D SureScan systems. The company said in a news release that the CRT-Ds would be available in the next few months and would allow patients to have MRI scans on any part of their body.

Medtronic said MRI scans are used to diagnose stroke, cancer, Alzheimer’s disease and muscle, bone and joint pain.

Research has shown that the Amplia MRI system decreased a patient’s odds of hospital readmission within 30 days by 59 percent compared with echo-optimized CRT. The device also improved CRT response rate by 12 percent and reduced the risk of atrial fibrillation by 46 percent compared with echo-optimized BiV pacing.

Before this approval, the FDA had noted that previous CRT-Ds were contraindicated in patients undergoing MRI scans because of a potential interaction between the device and the MRI.