Medtronic received FDA approval for its Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan cardiac resynchronization therapy defibrillators, making them the only MRI-conditional CRT-Ds so far to be available in the U.S.
The indications allow scans of any part of the body, given certain precautions are taken.
The implants work with the company’s Attain Perfoma MRI SureScan Quadripolar Leads that have themselves received FDA approval to be compatible with MRI scans.
The Amplia MRI device features the AdaptivCRT® algorithm, which has been shown to reduce a patient’s odds of a heart failure hospital readmission (within 30 days) by 59 percent (versus echo-optimized CRT). The AdaptivCRT feature also has been shown to improve CRT response rate by 12 percent, and to reduce AF risk by 46 percent compared to echo-optimized BiV pacing.
With 16 pacing configurations and shorter spacing between the two center electrodes, these quadripolar leads have been shown to reduce the incidence of phrenic nerve stimulation (PNS), a potential issue associated with CRT therapy that results in muscle twitching, hiccups or shortness of breath. Attain Performa leads also include steroid on all four electrodes for lower chronic pacing thresholds, which contribute to greater device longevity and reduce the likelihood of PNS. The systems also include VectorExpress(TM) technology, 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.