Medtronic (NYSE:MDT) landed an FDA win for an MRI-safe version of its RestoreSensor spine implant, touting the 1st ever clearance for such a implantable neurostimulation device that allows patients to go through an MRI.
The medical device giant said the 1st U.S. patients have already been implanted with the spinal chord stimulation device to treat chronic back pain, which has settings that allow patients to safely undergo scans that subject them to high levels of magnetic fields and radiofrequency energy.
The device, called the RestoreSensor SureScan MRI, is designed with percutaneous leads that significantly reduce their exposure to MRI-based hazards that may otherwise affect implanted devices. The devices also feature an MRI-safe mode that radiologists can trigger before putting a patient through the imaging system.
"In today’s medical practice, MRI examinations are necessary and routinely performed for diagnosis and clinical care," said Dr. Ali Rezai in a Medtronic press release. "It is very likely that a patient with chronic pain, spinal disease, neurological and orthopedic disorders will require an MRI scan. However, until now, this was not feasible with SCS implants."
In recent years Medtronic has released a slew of MRI-safe implants, including a handful of neurostimulators cleared in the European Union, CapSure Sense MRI SureScan pacemaker leads that won CE Mark in March 2012 and the Revo MRI SureScan pacemaker that won FDA approval in February 2011.