Medtronics presents initial data on world's first pacemaker to allow MRI

01 September 2008

Medical device maker Medtronic, Inc. has 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 at the European Society of Cardiology Congress.

Medtronics says the results of its clinical trials showed no MRI-related complications, and no arrhythmia or asystole (absence of electrical activity in the heart) during MRI scans conducted on patients as part of a worldwide clinical study.

Additionally, its study showed that the heart responded appropriately to the level of electrical stimulation it received from the device were met. A small number of patients experienced implant complications consistent with rates for other pacemaker implant procedures, but none were related to the MRI technology.

The trial is a prospective, randomised, controlled, unblinded, multi-center study, involving 470 individuals; 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 (consisting of the dual chamber EnRhythm MRI SureScan pacemaker and CapSureFix MRITM SureScan pacing leads, Model 5086MRI), 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.