FDA OKs Medtronic's defibrillator

Device manufacturer Medtronic has received U.S. Food and Drug Administration (FDA) approval for its Claria MRI Quad cardiac resynchronization 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 MRI units and features EffectivCRT, a new algorithm that automatically tailors the therapy to individual patients by adjusting pacing rates, the firm said.

Additional features on the Claria device include the following:

  • 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 atrial fibrillation risk compared with echo-optimized biventricular pacing
  • VectorExpress 2.0, an automated in-office test that reduces lead programming 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
  • SureScan MR-conditional labeling for full-body scans without positioning restrictions

Medtronic also submitted a premarket approval (PMA) application to the FDA for a multiple point pacing feature, which, if approved, would be available with the Claria MRI and Amplia MRI CRT-Ds. The feature is not currently approved for commercial sale in the U.S.

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