FDA approves Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan systems for heart failure- Medtronic

The FDA has approved Medtronic Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan systems for the treatment of heart failure. These magnetic resonance imaging (MRI) conditional cardiac resynchronization therapy defibrillators (CRT-Ds) are approved for MRI scans on any part of the body without positioning restrictions. Both CRT-D systems will be commercially available in the coming months.

The Amplia MRI device features the AdaptivCRT algorithm, which has been shown to reduce a patient's odds of a heart failure hospital readmission (within 30 days) by 59 percent (versus echo-optimized CRT). The AdaptivCRT feature also has been shown to improve CRT response rate by 12 percent, and to reduce AF risk by 46 percent compared to echo-optimized BiV pacing. Both newly approved devices can be paired with the Attain Perfoma MRI SureScan Quadripolar Leads.