Providence Saint Joseph Medical Center announces first patient in US to receive MRI scan in clinical study of MRI-compatible pacemaker


Providence Saint Joseph Medical Center is the first hospital in the USA to conduct a magnetic resonance imaging (MRI) scan of a patient implanted with a new MRI-compatible pacemaker.

Cardiothoracic surgeon Raymond Schaerf, implanted the Accent MRI pacemaker and Tendril MRI lead (St Jude Medical) in Karolyi Fenyvesi, 82, of Burbank, who last week successfully underwent magnetic resonance imaging.

Led by Schaerf, Providence Saint Joseph in Burbank (California, USA) 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, says 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 says. “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.”

In this clinical study, a pacemaker is implanted to help treat a patient with bradycardia. 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.

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 US Food and Drug Administration to start enrolment in this clinical study.