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FDA approves Medtronic’s Claria MRI CRT-D device to treat heart failure patients

The US Food and Drug Administration (FDA) has approved Medtronic's Claria MRI quad cardiac resynchronization therapy defibrillator (CRT-D) SureScan device to treat patients with heart failure.

The device, which has been approved to scan in both 1.5 and 3 Tesla (T) magnetic resonance imaging (MRI) machines, includes new EffectivCRT algorithm that automatically adjusts the therapy to individual patients by adjusting pacing rates.

It also features AdaptivCRT algorithm that is said to reduce patient's odds of a 30-day heart failure readmission by 59%, and  VectorExpress 2.0 automated in-office test that decreases lead programing to two minutes.

Claria’s Attain Perfoma MRI SureScan quadripolar leeds comprise of include short bipolar spacing to reduce phrenic nerve stimulation occurrence, steroid on all electrodes, and three shapes for varying patient anatomies.

In addition, the device includes SureScan(TM) MR-conditional labeling for full-body scans without positioning restrictions.

According to Medtronic, patients with certain existing defibrillation leads will be eligible for an MR-conditional ICD or CRT-D.

Medtronic cardiac rhythm and heart failure division medical director and heart failure business general manager and vice president Dr David Steinhaus said: "The Claria MRI CRT-D is our latest innovation to help improve patients' response to CRT, establishing a new level of personalized care.”

"And it further expands our industry-leading MR-conditional portfolio of devices, which are helping to improve the lives of more patients throughout the world."