Sunday, medical device maker Medtronic, Inc. (MDT), provided initial safety and efficacy data on its investigational pacemaker EnRhythm MRI SureScan Pacing System as a potential solution for patients with pacemaker, with the need for an MRI.
Medtronic said no MRI-related complications, no arrhythmia or asystole - absence of electrical activity in the heart, were detected during MRI on patients in a worldwide clinical study.
Currently patients with implanted pacemakers are prohibited from receiving magnetic resonance imaging or MRI scans, a widely practiced diagnostic method, as the device could interact with MRI machines, potentially affecting the device or patient safety.
The Minneapolis, Minnesota based company indicated other study endpoints showed that the heart responded appropriately to the level of electrical stimulation it received from the device were met. Few patients experienced implant complications consistent with rates for other pacemaker implant procedures, however, none related to the MRI technology.
Medtronic's trial is based on prospective, randomized, controlled, unblinded, multi-center study, involving 470 subjects. 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. The pacing system consists of the dual chamber EnRhythm MRI SureScan pacemaker and CapSureFix MRI SureScan pacing leads, Model 5086MRI. About two-thirds of the participants will receive MRI scans, with the first MRI scans in approximately two to three months after implant. The expected study duration and follow up time is approximately 30 months.
The initial safety and efficacy data was presented at the European Society of Cardiology Congress.
MDT closed Friday at $54.65, down $0.56 or 1.10%, on a volume of 4.27 million shares on the NYSE.
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