Minnesota’s Medtronic (NYSE:MDT) announced today that it won expanded approval from the FDA for its SureScan line of pacemakers, labeling them as safe for undergoing full-body MRI scanning.
Medtronic’s devices are the 1st and only pacemakers with the FDA’s seal of approval for compatibility with MRI scanning, and the new win indicates that patients can undergo imaging without positioning limitations, allowing patients to get chest MRIs which had previously been restricted.
"Because MRI is the standard of care for soft tissue imaging and is a critical component for early detection, diagnosis and treatment, this FDA approval will help more patients with SureScan pacemakers receive the MRI scans they need," Medtronic senior vice president and president of the cardiac rhythm disease management business Pat Mackin said in prepared remarks.
Medtronic provided the FDA with computer modeling as well as clinical data demonstrating that the implanted pacemakers can withstand MRI safety, according to a press release. The new labeling may bring some relief to patients with pacemakers, an estimated 75% of which may need MRIs in their lifetimes.
Medtronic won initial FDA approval for its MRI-friendly pacemakers in February 2011, with approval for its Revo MRI.