Canadian hospitals participate in first-ever clinical trial to evaluate new pacemaker system designed for use in MRI machines



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

    MISSISSAUGA, ON, June 18 /CNW/ - 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.

    About the Montreal Heart Institute

    Founded in 1954, the Montreal Heart Institute constantly aims for the
highest standards of excellence in the cardiovascular field through its
leadership in prevention, ultra-specialized care, training of professionals,
clinical and fundamental research and assessment of new technologies. It is
affiliated with the Université de Montréal, and its clinical outcomes are
among the best in the world. For more information on the Institute, please
visit our website at www.icm-mhi.org.

    About the Vancouver Island Health Authority

    Through a network of hospitals, clinics, centres, health units, and
residential facilities, the Vancouver Island Health Authority provides health
care to approximately 716,000 people on Vancouver Island, on the islands of
the Georgia Strait, and in the mainland communities north of Powell River and
south of Rivers Inlet. More than 16,000 VIHA health care professionals,
technicians, and support staff provide excellent care and service to people
living within the region.





For further information:

For further information: Laura Jablonski, Six Degrees Medical
Consulting, Tel.: (416) 643-8597, Email: ljablonski@sixdegreesmed.com

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