The FDA has approved Medtronic's ($MDT) IDE application and pivotal clinical trial protocol to begin evaluating the Advisa DR MRI SureScan pacing system. The randomized Advisa MRI study will seek to confirm the safety and effectiveness of the pacing system when subjects receive MRI scans under specified conditions.
Medtronic is the first company in the U.S. to conduct a randomized, controlled trial of a second generation pacing system designed for use in the MRI environment under specific scanning conditions, the devicemaker notes in a release. The FDA hasn't cleared the system for commercial distribution yet, but it has been available in Europe since last year.
"The FDA approval of the Advisa MRI System Study protocol brings us one step closer to providing patients with another pacemaker option designed for safe use in the MRI environment," said Pat Mackin, president of the cardiac rhythm disease management business and senior VP at Medtronic. "This clinical trial further demonstrates Medtronic's commitment to leading the industry with clinically proven innovative technologies that enable physicians to help sustain health and extend life."
Until the FDA's clearance of Medtronic's first-generation Revo MRI SureScan pacing system in February, MRI procedures had been contraindicated for patients with implanted pacemakers due to the potential for serious adverse events.
- check out the Medtronic release