FDA approves Medtronic’s cardiovascular devices and leads for MRI scanning

The U.S. Food and Drug Administration (FDA) approved Medtronic’s cardiac rhythm and heart failure devices and leads to be scanned in 1.5 and 3 Tesla magnetic resonance imaging (MRI) machines.

Medtronic said in a news release that 3T MRI offers better image quality, better diagnosis and reduced scan duration and is expected to be available in approximately 30 percent to 40 percent of U.S. hospitals within the next five years.

The FDA approval pertains to the following Medtronic devices: Advisa MRI pacemakers and Micra transcatheter pacemaker, Amplia MRI and Compia MRI cardiac resynchronization therapy defibrillators, Evera MRI and Visia AF MRI DF-1 and DF4 implantable cardioverter defibrillators, Reveal LINQ insertable cardiac monitor and SureScan pacing, defibrillation and left-heart leads.

Although an estimated 12 to 16 percent of patients with cardiac devices could use an MRI, fewer than 1 percent receive a scan due to device or lead restrictions, according to Medtronic.

“Approval for MRI conditional scanning at both 1.5 and 3T allows patients to have improved access to MRI at a time and place most appropriate for their care,” Yair Safriel, MD, neuroradiologist and chief medical officer at Pharmascan Clinical Trials and University of South Florida, said in a news release. “And with 3T scanning, physicians and radiologists gain a clearer look into soft tissues, particularly critical when diagnosing serious conditions, often involving the brain and spine.”