MARQUETTE, MICH – Marquette General cardiologist and electrophysiologist Mark Cowan, MD, became the first in the country to implant a defibrillator that is compatible with full body magnetic resonance imaging (MRI) scans as part of a clinical trial by Medtronic, recognized world leader in medical technology.
More than two million Americans depend on pacemakers or defibrillators to help regulate their heart conditions. While these implanted devices can save lives, they can also eliminate the possibility of utilizing MRI scans – which is another life-saving tool that detects tumors, bleeding, injuries, blood vessel diseases or infections. This is because the powerful magnet of the MRI can interrupt, move or overheat the ICD.
Minneapolis-based Medtronic seeks to change this with the Evera MRI™ SureScan® implantable cardioverter-defibrillator (ICD) System. Evera MRI is the first ICD system to be evaluated in the U.S. that allows for MRI scans positioned on any region of the body. The Evera MRI was recently approved for use in Europe.
With an estimated 63 percent of ICD patients needing an MRI within 10 years of receiving a device, the Medtronic trial is of great interest to patients and physicians, alike.
“The study will test the Medtronic Evera MRI ICD when patients who have this system have an MRI scan,” said Rudy Evonich, MD, principal investigator at Marquette General for the Evera MRI study. “Medtronic representatives will be on hand during the patient’s MRI to monitor the ICD throughout the scanning process. Results will then be compared to devices in a control group.”
Gary Green of Marquette, the first patient in the U.S. to receive the Evera MRI™ SureScan,® was a perfect candidate for the trial. At 55 years old, Green was having difficulties managing his heart condition despite weight loss, medication and close monitoring by his cardiologist. With Green’s family history of heart disease, and the fact he had suffered a heart attack in 2010, his cardiologist recommended an ICD implant. Green also undergoes periodic MRI scans due to back and hip issues, so there is a very high likelihood that he will need future MRI scans.
“I have to have the ICD anyway, so if my situation will help by providing information, I’m happy to participate in the study,” Green said. “Although I’m nervous about having the implant, the technology will be monitoring my heart and that makes me feel safe.”
About 275 subjects will take part in this study. There will be up to 45 sites in various countries, including the United States, Canada, Western Europe, Middle East and Africa, Greater China, India, and Latin America. Marquette General, the only Michigan hospital participating in the study and one of only 24 in the U.S., hopes to enroll two to three qualified patients into the study per month.
Marquette General has teamed with Medtronic on clinic trials for the last nine years as part of an ongoing mission to provide patients around the world with the best possible heart care. Dr. Evonich, cardiovascular research director Beth King and cardiovascular research team members Jodi Nease, RN, Jane Anderson, LPN, Adele Price, LPN, Lori Piggott and Michelle Duquaine have worked closely with Medtronic representatives in preparation to conduct the study here at Marquette General.
If you or a loved one are a candidate for an ICD, ask your doctor for more information about the Evera MRI™ SureScan® implantable cardioverter-defibrillator (ICD) System trial.
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