FDA approves Medtronic defibrillator that automatically adjusts pacing

Medtronic HQ

The FDA approved Medtronic’s defibrillator that tailors cardiac resynchronization therapy (CRT) to each patient by using an algorithm to adjust pacing. With its ability to confirm if pulses are effective, it has a leg up over other CRT devices, which can only report that a pulse was sent.

As its name suggests, the Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator SureScan device offers a bundle of features, including MRI compatibility and quadripolar leads, allowing the implant to complement varying patient anatomies. The EffectivCRT algorithm automatically adjusts heart pacing for individual patients, according to a statement.

The algorithm will be particularly useful in heart failure patients who have atrial fibrillation, an irregular heart rate that can impede a patient’s response to cardiac resynchronization therapy. The EffectivCRT Diagnostic gauges the effectiveness of pacing to the left ventricle and the algorithm automatically makes changes to pacing rates during atrial fibrillation without negatively affecting average heart rate, Medtronic said in the statement.

"Until now, CRT devices have shown only whether a pacing pulse was sent, but we haven't been able to determine if that stimulation actually improves the heart's pumping ability," said Dr. Suneet Mittal, director of the Electrophysiology Laboratory at the Arrhythmia Institute of the Valley Health System in New Jersey, in the statement. "With the Claria device, physicians are now able to verify the effectiveness of left ventricular pacing, which is especially beneficial for improving outcomes in patients with atrial fibrillation, who have been difficult to treat because this irregular and rapid heartbeat often interferes with the delivery of effective CRT."

Last month, Medtronic picked up an FDA nod for its SureScan line of MRI-compatible heart failure devices. Next up is introducing multiple-point pacing to some of its heart devices, including the Claria CRT defibrillator. The company has filed a premarket approval application for the technology, which could potentially improve patient response to CRT compared to single-site pacing.