Medtronic has begun an FDA-approved U.S. clinical trial to confirm the safety and efficacy of its EnRhythm MRI SureScan pacing system, a pacemaker system to be developed and tested for safe use during MRI procedures under specified scanning conditions.
The Minneapolis-based Medtronic said its EnRhythm MRI SureScan pacing system consists of the dual-chamber EnRhythm MRI SureScan pacemaker and CapSureFix MRI SureScan pacing leads.
The EnRhythm MRI SureScan pacing system trial is a prospective, randomized, controlled, unblinded, multi-center study, involving 470 individuals, Medtronic said. Eligibility is based on the clinical indication for pacemaker implantation and a willingness and ability to undergo elective MRI scanning. All patients in the trial will receive an EnRhythm MRI SureScan pacing system, and two-thirds of the participants will receive MRI scans; the trial's first MRI scans will occur approximately two to three months after device implant. The study will compare the electrical system performance, among patients in both groups. In addition, the study will assess the MRI-related complication rates in the month following the MRI scans. The study duration and follow up time is scheduled by the company to last approximately 30 months.
The first implant in the trial was performed by Brian Ramza, MD, PhD, director of electrophysiology laboratory services at the Mid America Heart Institute at Saint Luke's Hospital in Kansas City, Mo.
The system includes modified hardware to minimize the level of energy transmitted through the lead and device connection point, Medtronic said. The company said its pacemaker includes a SureScan feature that can be programmed on before an MRI scan to eliminate the impact of MRI-generated electrical noise.