Saluda Medical’s Evoke Spinal Cord Stimulation OK’ed for MRI Scans

Saluda Medical, a company developing neuromodulation therapies driven by closed-loop technologies, has been awarded MRI conditional labeling for its Evoke spinal cord stimulation (SCS) system.
 
Evoke, according to the company, is the first and only precision, dose-control SCS therapy powered by proprietary SmartLoop technology. The approval covers all commercially implanted Evoke patients in the U.S., as well as patients formerly enrolled in the ECAP study.
 
The SCS system automatically reads, records, and responds to the nerves’ response to stimulation over four million times daily for continually optimized therapy.
 
The approval offers patients implanted with Evoke the ability to undergo 1.5 or 3T head and extremity and 1.5T full-body MRI scans across most implant locations in the industry. Saluda said imaging can be done in both prone and supine positions.
 
Specific scan conditions and safety information are provided in Evoke’s MRI guidelines manual, the company said.
 
“This approval marks an important step in meaningfully expanding patients’ eligibility and access to the paradigm-shifting Evoke therapy,” Saluda Medical’s president and CEO Jim Schuermann told the press. “The Evoke System has been MRI-approved since 2019 in Europe and Australia and since 2022 for patients in the ECAP Study, a U.S. IDE study with 300 patients enrolled. With this approval, every current and future Evoke system patient across every region where the device is currently marketed will be able to undergo MRI scans.”
 
Evoke is indicated as an aid in to manage chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain.

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