Interventional technology firm Medtronic has begun a U.S. clinical trial to confirm the safety and efficacy of its EnRhythm MRI SureScan pacing system.
Designed specifically for safe use in MR scanners under specified scanning conditions, the pacemaker system consists of the Minneapolis-based firm's dual-chamber EnRhythm MRI SureScan pacemaker and CapSureFix MRI SureScan pacing leads.
The trial will be a prospective, randomized, controlled, unblinded multicenter study involving 470 individuals, according to the vendor. Patients will be eligible based on their clinical indication for pacemaker implantation and a willingness and ability to undergo elective MRI scanning. Medtronic expects the study duration and follow-up time will be approximately 30 months.
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