St. Jude Medical, Inc. has announced the first implant in its Accent MRI® Pacemaker and Tendril MRI® Lead IDE Study. The ultimate goal of the study is to determine if patients with these devices can safely undergo full-body, high resolution Magnetic Resonance Imaging (MRI) scans to better accommodate their medical needs. According to a company press release, the Accent MRI Pacemaker system, which is in used on an investigational basis, offers an advanced pacing platform that provides wireless telemetry and algorithms to help address individual patient conditions.
MRI scans provide imaging information to help evaluate the presence of certain diseases or conditions that may or may not be adequately assessed using other imaging methods, such as x-ray or ultrasound. Because traditional pacing systems may be affected during an MRI scan, patients are currently discouraged from receiving the scans. 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.
The Accent MRI Pacemaker and Tendril MRI Lead study, conducted under an FDA investigational device exemption (IDE) is a randomised, clinical trial assessing the safety and efficacy of the Accent MRI system in patients with standard bradycardia who are indicated for a pacemaker. The clinical trial 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 randomised to receive an MRI after enrollment in the study.
“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 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 full press release can be found here.
Source: St. Jude Medical Inc., Business Wire