Irish medical technology firm Medtronic has received approval from the US Food and Drug Administration (FDA) for their magnetic resonance imaging (MRI) conditional cardiac resynchronization therapy defibrillators (CRT-Ds) to treat heart failure.
The firm has obtained FDA approval for Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan systems to perform MRI scans on any part of the body without positioning restrictions.
Medtronic cardiac rhythm and heart failure division medical director David Steinhaus said: "With FDA approval of Amplia MRI and Compia MRI, Medtronic continues to lead the market in MR-conditional implantable cardiac devices, bringing greater access to patients that need this vital diagnostic test to identify other potential life-threatening diseases.
"Medtronic is committed to continuing to develop innovative technologies that offer physicians a wide range of technology options to help them improve outcomes for heart failure patients."
Featuring quadripolar technology, both devices provide multiple options to physicians for the treatment of heart failure by optimizing CRT delivery.
Amplia MRI device features the AdaptivCRT algorithm, which is said to reduce patient’s odds of a heart failure hospital readmission by 59% compared to echo-optimized CRT.
Both devices can also be paired with Attain Perfoma MRI SureScan Quadripolar leads, including Dual Cant MRI SureScan Model 4298, Straight MRI SureScan Model 4398 and S MRI SureScan Model 4598.
With 16 pacing configurations and shorter spacing between the two center electrodes, these quadripolar leads were shown to reduce the incidence of phrenic nerve stimulation (PNS).
The firm also received FDA approval for MR-conditional pacemakers in 2011 and implantable cardioverter defibrillators (ICDs) in 2015.
Image: Amplia MRI cardiac resynchronization therapy-defibrillator. Photo: courtesy of Medtronic plc.