Interventional device developer Medtronic has received U.S. Food and Drug Administration (FDA) approval for an investigational device exemption (IDE) of its second-generation Advisa DR MRI SureScan pacing system.
The FDA has also approved the company's clinical trial protocol to begin evaluating the investigational device, which is designed for use in the MRI environment under specific scanning conditions, according to the vendor.
Medtronic said it would conduct a randomized, controlled, nonblinded, multicenter worldwide investigational study to confirm the safety and effectiveness of the pacing system in the clinical MRI environment, as well as to provide data on MR image quality in the presence of the pacing system.
