Medtronic Inc. said Monday that the Food and Drug Administration approved its application to conduct a clinical trial in the United States evaluating a new pacemaker that is compatible with MRI scans.
The clinical trial will test the Advisa DR MRI SureScan pacing system, which is a more-advanced version of a similar pacemaker approved by regulators last year.
A maximum of 270 patients will be enrolled worldwide in the study, which will take 36 months to complete. It's unclear how many U.S. patients will be enrolled in the study.
Patients with pacemakers are advised against getting the commonly used diagnostic scan. Fridley-based Medtronic estimates that 50 percent to 75 percent of patients with the implanted device, which regulates the heart's rhythm, will need an MRI scan over the lifetime of their device.
