US FDA approves Medtronic’s Claria MRI Quad cardiac resynchronisation therapy defibrillator

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Medtronic Claria MRI quad CRT D SureScan with leads
Medtronic Claria MRI quad CRT D SureScan with leads

Medtronic has received US Food and Drug Administration (FDA) approval for the Claria MRI Quad cardiac resynchronisation 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 (T) magnetic resonance imaging (MRI) machines, and features EffectivCRT, a new algorithm that automatically tailors the therapy to individual patients by adjusting pacing rates.

“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,” says Suneet Mittal, director, Electrophysiology Laboratory, Arrhythmia Institute of the Valley Health System, Ridgewood, USA. “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 Claria device includes the company’s EffectivCRT Diagnostic, which is designed to automatically determine the effectiveness of each left ventricular pace, and the EffectivCRT during AF algorithm, which is intended to automatically adjust pacing rates during AF, without adversely affecting the average heart rate.

According to a company release, additional features of the Claria device include:

  • The AdaptivCRT algorithm, which reduces a patient’s odds of a 30-day heart failure readmission by 59%, and has demonstrated a 46% reduction in AF risk compared to echo-optimised biventricular pacing.
  • VectorExpress 2, an automated in-office test that reduces lead programing to two minutes, and reveals clinically actionable information to help physicians select optimal pacing configurations for each patient.
  • Attain Perfoma MRI SureScan quadripolar leads, which include short bipolar spacing to reduce phrenic nerve stimulation occurrence, steroid on all electrodes, and three shapes for varying patient anatomies.
  • SureScan MR-conditional labelling for full-body scans without positioning restrictions.

Medtronic also has submitted a pre-market application (PMA) to the FDA for Multiple Point Pacing, which, if approved, would be available with the Claria MRI and Amplia MRI CRT-Ds. The Multiple Point Pacing feature is not currently approved for commercial sale in the USA.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.