Medtronic’s investigational EnRhythm MRI SureScan pacing system shows promise as a potential solution for patients receiving their first pacemaker and needing an MRI scan, according to initial safety and efficacy data presented Sunday at the European Society of Cardiology (ESC) Congress in Munich, Germany.
The trial is a prospective, randomized, controlled, unblinded, multi-center study, involving 470 individuals, according to the Minneapolis-based Medtronic.
Results presented showed no MRI-related complications, and no arrhythmia or asystole during MRI scans conducted on patients, the company reported. Additionally, other study endpoints were met, which showed that the heart responded appropriately to the level of electrical stimulation it received from the device.
However, Medtronic said that a small number of patients experienced implant complications, but none were related to the MRI technology.
“MRI is unmatched and irreplaceable in the diagnosis of cancer and neurological disorders,” said lead European radiology investigator Torsten Sommer, MD, chief of the cardiovascular section of the radiology department, University of Bonn in Germany. “And for investigation of the brain and spinal cord, there is simply no suitable alternative in most cases.
“This data is promising,” Sommer said. “While the trial is ongoing, we’ve observed no lead-performance issues or unexpected MRI effects in this patient group to date.”
The clinical trial will include up to 470 patients at 53 centers in Europe, the Middle East, Canada and the United States. The company said that all patients in the trial will receive an investigational EnRhythm MRI SureScan pacing system (consisting of the dual chamber EnRhythm MRI SureScan pacemaker and CapSureFix MRI SureScan pacing leads, Model 5086MRI), and two-thirds of the participants will receive MRI scans—the first MRI scans occur about two to three months after device implant. The study will compare the electrical system performance, among patients in both groups. The expected study duration and follow-up time is approximately 30 months.