News | April 21, 2014

First U.S. Patient Receives MRI Scan in Clinical Study of St. Jude MRI-Compatible Pacemaker

Providence Saint Joseph Medical Center announces first scan in study

First U.S. Patient MRI Scan Clinical Study MRI-Compatible Pacemaker Accent MRI

April 21, 2014 — Providence Saint Joseph Medical Center in Burbank, Calif., is the first hospital in the nation to conduct a magnetic resonance imaging (MRI) scan of a patient implanted with a new MRI-compatible pacemaker — a breakthrough because metal implants often exclude patients from this imaging because of the strong magnetic force.

Cardiothoracic surgeon Raymond Schaerf, M.D., implanted the Accent MRI Pacemaker and Tendril MRI Lead in Karolyi Fenyvesi, 82, of Burbank, who successfully underwent magnetic resonance imaging.

Led by Schaerf, Providence Saint Joseph was part a global clinical study to help determine if a patient can safely and effectively undergo a full-body, high-resolution MRI scan with the Accent MRI system.

Many patients with pacemakers and defibrillators need MRI studies to help with their care and diagnoses, said Schaerf, a leader in the study of MRI use on patients with implanted devices including pacemakers and defibrillators. The Accent pacemaker was designed to be compatible with MRI, often the preferred diagnostic tool for some medical conditions such as cancer, stroke, spine and neurological disorders.

"We have been privileged to have done more than 400 MRI studies through an FDA-approved study over the last six years, but are restricted in what studies can be performed," Schaerf said. "With this device and system, we have made a great leap forward, and in this patient actually did an MRI of the heart, with no problems and no artifacts on the scan caused by metal."

Cardiac pacemakers are used to help treat abnormal heart rhythms. In this clinical study, a pacemaker is implanted to help treat a patient with bradycardia, a dangerously slow heart rate. A pacemaker helps monitor the heart and provides electrical stimulation when the heart beat is too slow.

The investigational Accent MRI pacemaker and Tendril MRI lead can be used for full-body scans without any anatomical restrictions because of technology designed to protect a patient from the risks associated with an MRI environment.

More than 60 million MRI scans are performed each year around the globe. Pacemaker patients typically are discouraged from receiving MRI scans because their pacing system may be affected during the scan.

The Accent MRI Pacemaker and Tendril MRI lead, developed by St. Jude Medical, are available in Europe and Japan. In March 2012, St. Jude Medical received conditional investigational device exemption approval from the U.S. Food and Drug Administration (FDA) to start enrollment in this clinical study.

For more information: www.california.providence.org.

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