Health Canada Licenses Medtronic MRI Conditioning Spinal Cord Stimulator

Got back or leg pain? Medtronic Canada and Health Canada have a deal for you.

According to a November 8, 2016 press release, Medtronic Canada’s new Specify SureScan MRI surgical leads, part of Medtronic plc’s spinal cord stimulation (SCS) implant system, is now licensed by Health Canada. Health Canada is the federal department responsible for helping Canadians maintain and improve their health.

In 2013, Medtronic introduced the first implantable neurostimulation systems for use in the treatment of chronic, intractable back and/or limb pain that are licensed for full-body Magnetic Resonance Imaging (MRI) scans under specified conditions. Spinal cord stimulators are implanted under the skin and send mild electrical pulses to an area near the spine. These pulses disrupt the pain signals traveling between the spinal cord and the brain. The company says the pulses offer patients effective pain relief and improved function.

“An important development in the field of neuromodulation is the availability of MRI conditional devices. These devices allow for patients to undergo routine MRIs and continue to benefit from neuromodulation therapy—a previously unmet need for many of our patients, ” said Suneil Kalia, M.D., Ph.D., FRCSC, neurosurgeon at the Krembil Neuroscience Centre at Toronto Western Hospital.

The company says some individuals with an SCS system have traditionally been limited when receiving MRI scans, as the scans produce electromagnetic fields that can damage the device or cause injury to the patient. These patients have the option of undergoing computerized tomography (CT) scans, which work well for imaging bones and other hard materials, but are less effective in examining soft tissue. In some cases, people needing an MRI have had the system explanted prior to imaging.

Mohammed Shamji, M.D., Ph.D., FRCSC also from the Krembil Centre, said most patients implanted with SCS devices will need MRI studies in the future, “…and until now they have either undergone other more invasive examinations or had the SCS device explanted. Physicians and patients can now approach this therapy with the confidence that their ability to access future diagnostic procedures won’t be lost. This innovation has raised the bar in the delivery of neuromodulation for treatment-refractory neuropathic pain.”

“The use of MRI as a diagnostic tool has grown significantly. Studies show that 82% of patients implanted with a SCS are expected to need an MRI within five years of receiving their implant. Medtronic appreciates the opportunity to offer physicians the only full portfolio of SCS systems in Canada that allow patients access to full-body MRIs, facilitating optimal patient care and timely interventions, ” said Sandrine Moirez, senior business director of the Restorative Therapies Group at Medtronic Canada.