St. Jude Medical is about to find out whether what it claims is an “MRI-safe” pacemaker lives up to its name—the company has implanted its Accent MRI pacemaker with Tendril MRI leads in a clinical trial. The goal of the investigational device exemption (IDE) study is to determine if patients with these devices can safely undergo a full-body, high resolution magnetic resonance imaging (MRI) scan if necessary.
MRI scans are the only reliable method of diagnosis for many diseases and conditions, which is why it is important for everyone to have access to them. Because they operate with high magnetic forces, they adversely can affect implanted devices. Approximately 1 million people are implanted with pacemakers worldwide, and approximately 300,000 of those patients could benefit from scans of the major organs and bones in the thoracic region of the body during the lifetime of their devices . Thus the Accent pacemaker—if successful in the trial and approved—could be a major asset to such patients.
“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 Raymond Schaerf, M.D., thoracic surgeon at Providence Saint Joseph Medical Center in Burbank, Calif., who 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.”
The Accent/Tendril clinical trial is a randomized, clinical study that will take place at a maximum of 80 centers worldwide and will enroll approximately 800 patients. All patients in the study will be implanted with an Accent MRI Pacemaker and a Tendril MRI lead and be followed for 12 months post-implant to evaluate the acute and chronic performance of the system. A subset of patients will be randomized to receive an MRI after enrollment in the study.
The Accent pacemaker can transmit telemetry and algorithms wirelessly, leaving it vulnerable to possible hacking, a growing problem for wireless medical devices and the U.S. Food and Drug Administration (FDA). The issue took center stage last year after McAfee Labs assembled an elite team of hackers to attack embedded devices and a Type 1 diabetic Idaho man successfully manipulated an insulin pump he used. The FDA now is scrutinizing all wireless devices more closely before they are cleared or approved, while at the same time facing pressure from other government groups such as the House Energy and Commerce Committee to speed up approvals.
Eyes will be fixed on St. Jude, not only as the company adds wireless devices to its portfolio, but also as it tries to recover from questions about the safety of its heart devices. St. Jude has been struggling to reverse the negative attention garnered for the widespread failure of its Riata lead wires. The Tendril leads are coated with St. Jude’s patented Optim coating, as opposed to silicone, which is what caused the problems in the Riata leads.
St.Paul, Minn.-based St. Jude Medical develops cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation products.