Saluda Medical Receives FDA Approval for Evoke® System MRI Labeling

Saluda Medical, Inc. ("Saluda Medical"), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved MRI conditional labeling for the Evoke^® System, the first and only precision, dose-control spinal cord stimulation (SCS) therapy powered by SmartLoop™ technology. This approval applies to all commercially implanted Evoke^® System patients in the United States as well as patients formerly enrolled in the ECAP Study.

The Evoke^® system's MRI labeling is one of the most comprehensive in the SCS space. The approval provides patients implanted with the Evoke^® System the ability to undergo 1.5 or 3.0T head and extremity and 1.5T full-body MRI scans across the most implant locations in the industry. Imaging can be done in both prone and supine positions. Specific scan conditions and safety information are provided in the Evoke^® SCS System MRI Guidelines manual.

"This approval marks an important step in meaningfully expanding patients' eligibility and access to the paradigm-shifting Evoke therapy," said Jim Schuermann, President and CEO of Saluda Medical. "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."