FDA Approves Defibrillator That Automatically Adjusts Pacing

First resynchronization therapy defibrillator with pacing algorithm

The FDA has cleared the Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device (Medtronic) for patients with heart failure. The device 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 (AF), which can significantly reduce the patients’ responses to CRT, according to Medtronic. 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.

The Claria device also includes the AdaptivCRT algorithm, which reduces a patient's odds of a 30-day heart failure readmission by 59%, and VectorExpress 2.0, an automated in-office test that reduces lead programing to two minutes.

Source: Medtronic; November 14, 2016.