FDA approves Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator for heart failure- Medtronic

Medtronic has received U.S. FDA approval for the Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device for patients with heart failure. The Claria MRI CRT-D is approved for scanning in both 1.5 and 3 Tesla magnetic resonance imaging machines, and features EffectivCRT, a new algorithm that automatically tailors the therapy to individual patients by adjusting pacing rates.

A large percentage of heart failure patients receiving cardiac resynchronization therapy have atrial fibrillation which can significantly reduce patient response to CRT. The Claria device includes the EffectivCRT Diagnostic, which automatically determines the effectiveness of each left ventricular pace, and the EffectivCRT during AF algorithm, which automatically adjusts pacing rates during AF, without adversely affecting the average heart rate. Medtronic has also submitted a Pre-Market Application to the FDA for Multiple Point Pacing, which, if approved, would be available with the Claria MRI and Amplia MRI CRT-Ds.