According to Bloomberg Businessweek, approximately 1.5 million Americans are implanted with a device to regulate heart rhythms. About 75% of these patients develop cancer or other medical conditions that require a magnetic resonance imaging (MRI) scan during their lifetime. However, currently available pacemakers are not compatible with MRI scans as the magnetic fields in the scan may disrupt the pacemaker’s settings or cause wires to overheat.
Medtronic’s Revo MRI SureScan Pacing System allows patients to undergo multiple MRI scans without causing device malfunction. Once the device is released in the U.S., Medtronic proposes that a five-year study on the safety and effectiveness of the product be conducted on 1,810 patients.
The conditions that the FDA panel recommended include a post-approval study, a training program for doctors and a prominent label on the product’s packaging indicating that the device only be used with a compatible wire or lead.
More information on Medtronic’s device can be found here: