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news.Medical technology company Medtronic has reported initial safety and efficacy data of its investigational EnRhythm MRI SureScan pacing system, for patients receiving their first pacemaker and needing an MRI scan.
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Results presented showed no magnetic resonance imaging (MRI)-related complications, and no arrhythmia or asystole during MRI scans conducted on patients as part of a worldwide clinical study.
Additionally, other study endpoints showing that the heart responded appropriately to the level of electrical stimulation it received from the device were met.
The EnRhythm MRI SureScan system clinical trial is a prospective, randomized, controlled, unblinded, multi-center study, involving 470 individuals. The 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 investigational EnRhythm MRI SureScan pacing system and two-thirds of the participants will receive MRI scans. The 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 expected study duration and follow up time is approximately 30 months.