Saluda Medical Secures US FDA Approval For Evoke System MRI labelling

The US Food and Drug Administration (FDA) has authorized MRI conditional labeling for the Evoke System, the first and only precision, dose-control spinal cord stimulation (SCS) therapy driven by SmartLoop technology according to Saluda Medical, Inc. This approval is valid for all commercially implanted Evoke System patients in the United States, as well as those who previously participated in the ECAP Study. The Evoke system’s MRI labelling 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, as per Minneapolis.

“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 US 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.” Saluda Medical is a multinational firm that uses innovative brain sensing technologies to alter patients' lives and advance the area of neuromodulation.