RestoreSensor SureScan MRI Neurostimulator FDA Approved for Full Body MRI

Medtronic is now offering the first pain therapy neurostimulator approved by the FDA for conditionally safe full-body MRI scanning.

The RestoreSensor spinal cord stimulator features SureScan MRI technology that places the device into an appropriate mode for scanning and uses Vectris SureScan leads that prevent interference with the scanner’s magnet and radio waves.

From Medtronic’s announcement:

“The ability to safely perform MRI scans after a spinal cord stimulator implant (SCS) is an important advance and a major benefit for our patients,” said Ali Rezai, M.D., professor and director of the Center for Neuromodulation and Functional Neurosurgery at The Ohio State University Wexner Medical Center in Columbus, Ohio. “In today’s medical practice, MRI examinations are necessary and routinely performed for diagnosis and clinical care.  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.  I am happy that we will now be able to offer MRI scans for our patients.”

The RestoreSensor SureScan MRI neurostimulation system is one of a portfolio of new Medtronic neurostimulation systems enhanced with this technology and using Vectris®SureScan® MRI leads, which include: PrimeAdvanced® SureScan MRI, RestoreAdvanced®SureScan MRI, and RestoreUltra® SureScan MRI. The systems received FDA approval in March 2013 and Conformité Européenne (CE) Mark approval in January 2013.

Press release: Medtronic Introduces the First and Only Neurostimulation Systems for Chronic Pain Designed for Full-Body MRI Safety…