Jude Medical, Inc., a global medical device company, today announced a study to find out whether patients with certain heart implants can safely undergo full-body, high resolution Magnetic Resonance Imaging (MRI) scans to better accommodate their medical needs.
The company will survey, through its Accent MRI Pacemaker and Tendril MRI Lead IDE Study (MRI Study), the investigational Accent MRI Pacemaker system from St. Jude Medical, which provides “an advanced pacing platform that provides wireless telemetry and algorithms to help address individual patient conditions,” according to a company press release.
With MRI scans, physicians can see deep into the body’s interior without surgery by using strong magnets and pulses of radio waves to manipulate the natural magnetic properties in the body. This scanning technique allows doctors to see better images of organs and soft tissues than they can with other scanning technologies.
Patients have been discouraged from having MRIs in the past because, as the press release explains, traditional pacing systems may be adversely affected by the scan.
But of the approximately 1 million people implanted with pacemakers worldwide, about one-third could benefit from scans of the major organs and bones in the thoracic region of the body during the lifetime of their devices, according to the press release.
“Because young pacemaker patients have a high likelihood of needing an MRI over their lifetime, and older pacemaker patients often have co-morbidities, they may have other conditions, which could benefit from MRI scans of internal organs or major bones and in particular may benefit from cardiac MRI scans,” said Dr. Raymond Schaerf with Providence Saint Joseph Medical Center in Burbank, Calif., who, according to the press release, implanted the first pacemaker in the study.
“Currently, there is no pacemaker available that allows for full-body MRI scans, which further assists physicians in the early diagnosis and treatment of certain diseases, such as cancer or stroke, as well as other medical conditions facing heart patients.”
In the study, approximately 800 patients will be implanted with an Accent MRI Pacemaker and a Tendril MRI lead and be followed for one year after the procedure to evaluate the acute and chronic performance of the system. A randomized subset of this group will then receive an MRI after enrollment in the study, according to the press release.
The press release reveals that cardiac pacemakers are used to treat bradycardia, which is a heart rate that is too slow, monitoring the heart and providing electrical stimulation when a heartbeat is too slow for a patient's specific physiological requirements.
Sciencedaily.com reported back in 2009 that FDA researchers found that certain cardiac pacemakers might inadvertently stimulate a patient's heart while undergoing an MRI, a potentially dangerous situation for the patient, according to research published in BioMed Central's open access journal BioMedical Engineering Online.
Edited by
Jennifer Russell
