Medtronic obtains FDA approval for Claria MRI Quad CRT device for heart failure

15 November 2016 (Last Updated November 15th, 2016 18:30)

Medtronic has secured the US Food and Drug Administration (FDA) approval for its Claria MRI Quad Cardiac Resynchronisation Therapy Defibrillator (CRT-D) SureScan device for patients with heart failure.

Medtronic has secured the US Food and Drug Administration (FDA) approval for its Claria MRI Quad Cardiac Resynchronisation Therapy Defibrillator (CRT-D) SureScan device for patients with heart failure.

Approved for scanning in both 1.5 and 3 Tesla (T) magnetic resonance imaging (MRI) machines, the Claria device features a new algorithm, EffectivCRT, which automatically customises the therapy to individual patients by adjusting pacing rates.

Arrhythmia Institute of the Valley Health System electrophysiology laboratory director Suneet Mittal said: "Until now, CRT devices have shown only whether a pacing pulse was sent, but we have not been able to determine if that stimulation actually improves the heart's pumping ability.

"The device is incorporated with the AdaptivCRT algorithm which minimises the chance of a patient’s heart failure readmission by 59% and has reduced 46% atrial fibrillation risk."

"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."

Among other features, the device is incorporated with the AdaptivCRT algorithm which minimises the chance of a patient’s heart failure readmission by 59% and has reduced 46% atrial fibrillation risk.

The Claria device includes the automated in-office VectorExpress test which decreases lead programing to two minutes and reveals clinically actionable information to enable physicians choose optimal pacing configurations for each patient.

The Attain Perfoma MRI SureScan Quadripolar Leads features short bipolar spacing to reduce phrenic nerve stimulation occurrence, steroid on all electrodes, and three shapes to accommodate different patient anatomies.

The device also features SureScan MR-conditional labeling for full-body scans without positioning restrictions.