This article is more than 5 years old. Information may no longer be current.
Medtronic receives FDA approval for CRT device
The FDA approved Medtronic’s Claria MRI Quad cardiac resynchronization therapy defibrillator SureScan device for the treatment of HF, according to a company press release.
The device also features a new algorithm that automatically adjusts to patients’ individual needs to treat HF and arrhythmia disorders.
“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,” Suneet Mittal, MD, director of electrophysiology at the Arrhythmia Institute of the Valley Health System in Ridgewood, New Jersey, said in the release. “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.”
The devices include predictive algorithms that adjust pacing rates during AF. The AdaptivCRT algorithm (Medtronic) reduces a patient’s odds of a readmission for HF by 59% and reduced AF risk by 46% compared with echo-optimized biventricular pacing.
The device is approved for scanning in both 1.5-T and 3-T MRI machines.