Medtronic gets FDA nod for MRI Compatible Neuromodulation System for chronic pain

Medtronic’s new Specify SureScan surgical lead gained FDA approval, making its spinal cord stimulation system compatible with a full-body MRI scan, the company stated in a press release.

This allows people with intractable back or limb pain who will be implanted with the new lead to undergo full-body MRI. The company cited a study that shows 82% of patients implanted with a spinal cord stimulator are expected to need an MRI within five years of receiving their implant.

MRI scans are a diagnostic standard that allows physicians to detect and diagnose a wide range of conditions by viewing highly detailed images of internal organs, muscles, joints, and other systems in the body. MRI uses powerful magnetic fields and radio frequency pulses that create detailed images of systems and structures inside the body.

“All patients with a spinal cord stimulation system should have the ability to be offered the same imaging options as those without one,” said Steven Falowski, M.D., neurosurgeon at St. Luke’s University Health Network in the press release.

Now more than ever, patients and other health care providers are concerned about access to MRI when considering an implantable device. This approval means I can offer a neurostimulation system that helps manage my patients’ pain and gives them access to the diagnostic benefits of MRI,” Dr. Falowski added.

Medtronic (NYSE: MDT) cited statistics showing that back pain affects 8 out of 10 people at some point during their lives, and went on to say, “for some people, noninvasive options, such as medication and physical therapy, provide adequate relief; others may require surgery, nerve blocks, or medical devices, such as spinal cord stimulators or drug pumps. Spinal cord stimulators are medical devices implanted under the skin that send mild electrical pulses to an area near the spine. These pulses disrupt the pain signals traveling between the spinal cord and the brain, offering patients effective pain relief and improved function.”

National Pain Report has covered many advances in the field of neuromodulation, including new companies entering the market and new methods of delivering pain-relieving stimulation to the spinal cord.