Marquette General Hospital is the first hospital in the entire nation to implant an MRI-safe defibrillator.
The Minneapolis-based Medtronic piece is an implantable cardioverter-defibrillator. In other words, it??s now compatible with an MRI. Previously, a normal pacemaker or defibrillator would be affected by the magnet in the MRI.
??There are a number of diseases where the MRI is the gold standard for diagnosing,?? said Cardiac Electrophysiologist, Rudy Evonich. ??They??re the best way, sometimes the only way of diagnosing it, and so most patients we see these days are probably going to have an MRI at some point in their life.??
Out of all the sites in the nation, Marquette General was chosen as the first to partake in the cardiac clinical trial.
??It was a pleasure for us to be involved in the clinical trial,?? said Director of Cardiac Electrophysiology, Mark Cowan. ??There are only 44 centers in the world that have been selected; there are only 25 centers in the United States, and only one from Michigan, so we were quite pleased to be asked by Medtronic to be involved in the clinical trial.??
So far, there have been two successful implants done at Marquette General, and more are to be expected.
??Overtime these people are followed and a portion of them are brought back and we actually do an MRI on them, even if they don't need an MRI and that's part of the study to see how the device performs in the MRI environment, and to make sure there's no change in the amount of energy you have to send down the wire to stimulate the heart,?? Evonich said.
??It'd be a huge advantage for people given the projected number of MRIs that are going to be required in people,?? Cowan said.
In total, about 275 subjects will take part in the study. Countries participating include the United States, Canada, Western Europe, Middle East and Africa, Greater China, India, and Latin America. Currently, the implants are approved in Europe. The FDA is waiting to approve the devices pending the clinical trial results.