Image: The Accent MRI pacemaker and Tendril MRI lead (Photo courtesy of St. Jude Medical).
A California hospital is first in the United States to conduct magnetic resonance imaging (MRI) of a patient implanted with a new MRI-compatible pacemaker.
Cardiothoracic surgeon Raymond Schaerf, MD implanted the Accent MRI pacemaker and Tendril MRI lead in an 82-year-old patient, who successfully MRI scanning. Led by Dr. Schaerf, from Providence Saint Joseph Medical Center (Burbank, CA, 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 require MRI studies to help with their care and diagnoses, according to Dr. 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, frequently the favored diagnostic approach for certain medical disorders such as cancer, stroke, spine and neurologic disorders.
“We have been privileged to have done more than 400 MRI studies through an FDA [US Food and Drug Administration]-approved study over the last six years, but are restricted in what studies can be performed,” Dr. 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.”
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 setting.
The Accent MRI Pacemaker and Tendril MRI lead, developed by St. Jude Medical (St. Paul, MN, USA), 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 enrollment in this clinical study.
Providence Saint Joseph Medical Center
St. Jude Medical