New pacemaker system designed for use in MRI machines

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• 2007-06-18 09:06:05
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Canadian hospitals participate in first-ever clinical trial to evaluate new pacemaker system designed for use in MRI machines

Monday June 18
Unique pacemaker and lead features could enable hundreds of thousands of people worldwide to get MRI scans even with an implanted cardiac device.

Physicians at Royal Jubilee Hospital in Victoria, B.C., Foothills HSC in Calgary, AB, Hôpital Laval in Québec, Montreal Heart Institute, Québec, and the London HSC in Ontario are participating in an international clinical trial to study a unique pacemaker system, the Medtronic EnRhythm(R) MRI SureScan(TM) pacing system, the first-ever to be developed and tested specifically for use in Magnetic Resonance Imaging (MRI) machines under specified scanning conditions. Canada's first clinical trial devices were recently implanted in a 71 year-old male by Dr. Bill Griswold, Vascular Surgeon in Victoria B.C. and in a 43 year-old woman by Dr. Mario Talajic, Electrophysiologist at the Montreal Heart Institute, where Dr. Bernard Thibault is the Principal Investigator for the study.

The EnRhythm(R) MRI SureScan(TM) pacing system consists of the new dual-chamber EnRhythm(R) MRI SureScan(TM) pacemaker and CapSureFix(R) MRI SureScan(TM) pacing leads (Model 5086MRI). The clinical trial, a prospective, randomized controlled, unblinded, multi-center study, is planned to occur at hospitals in Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Switzerland, United States and United Kingdom. Approximately 350 individuals will participate in the study, and eligibility is based on the clinical indication for pacemaker implantation and a willingness and ability to undergo elective MRI scanning.

"I would say that it is very exciting to finally have the possibility of a pacing system that is compatible with MRI scanners. Cardiac pacemaker patients occasionally require MRI diagnostic evaluations for a range of neurologic and musculo-skeletal ailments. Since MRI scanning is contraindicated in pacemaker patients, one is forced to use other non-optimal modalities such as CT scanning. An MRI compatible pacemaker therefore would open up a wider range of diagnostic possibilities," said Dr. Richard Leather, Electrophysiologist and Director of Heart Health at Vancouver Island Health Authority (VIHA).

Currently, individuals with implantable cardiac devices are denied an MRI scan every three minutes in the United States and every six minutes in Europe.

All patients in the trial will receive an EnRhythm(R) MRI SureScan(TM) pacing system, and approximately half 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 and diagnostic system performance, as well as complication rates, among patients in both groups. The expected study duration is approximately 24 months.