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First MR-conditional CRT-D receives FDA approval
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Medtronic announced that it has received FDA approval for the first MRI-conditional cardiac resynchronization therapy defibrillators for the treatment of HF.
The systems (Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan, Medtronic) are approved for MRI scans on any part of the body, with no positioning restrictions.
“What’s clear from the data and my own personal experience is that a large majority of CRT-D patients will likely need an MRI at some point. Now that CRT-D MRI devices are approved, patients can receive an MRI in a straightforward manner,” J. Rod Gimbel, MD, from Case Western Reserve University, Cleveland, said in a press release issued by Medtronic. “This is a significant development for [HF] patients with CRT-D therapy.”
According to the release, the Amplia device features the AdaptivCRT algorithm, which has been shown to reduce hospital readmission and atrial fibrillation risk and improve CRT response rate.
Both devices can be paired with quadripolar leads (Attain Performa MRI SureScan, Medtronic), which have 16 pacing configurations and shorter spacing between the two center electrodes, reducing the incidence of phrenic nerve stimulation that can lead to muscle twitching, hiccups or shortness of breath, the company stated in the release.
Medtronic was the first company to receive FDA approval for MR-conditional pacemakers in 2011 and implantable cardioverter defibrillators in 2015, according to the release.
Disclosure: Gimbel reports consulting for Medtronic.