A new heart pacemaker from Minnesota-based Medtronic Inc., called the Revo MRI SureScan Pacing System, has received approval from the U.S. Food and Drug Administration as being safe even during magnetic resonance imaging scans on the patient.
Around 5 million cardiac patients worldwide have been implanted with a pacemaker that generate electric impulses to treat irregular or stalled heartbeats. However, till now, these patients have never been able to go for an MRI exam even if other health investigations called for it, because the magnetic and radiofrequency fields used by the MRI could lead to serious disruptions in the pacemaker's settings or functioning and could even prove to be fatal.
However, according to a release from the FDA, the new device Revo includes a function that is turned on before a scan to prepare patients with pacemakers for the MRI. As part of a clinical trial among patients successfully implanted with the device, none of the 211 who underwent an MRI experienced an MRI-related complication. This confirmed earlier data from animal studies, computational modeling, and other nonclinical research.
However, the FDA approval also comes with a caveat, pointing to the fact that the pacemaker's use in MRIs would be limited to certain patients, certain parts of the body, and certain scanning parameters. It would also require targeted training for cardiologists and radiologists who use the system.
Reuters reports that the company will begin shipping the product immediately and analysts expect it to re-accelerate growth in Medtronic's cardiac rhythm management division.