Saluda Medical has announced that the US Food and Drug Administration (FDA) has approved magnetic resonance imaging (MRI) conditional labelling for its Evoke system, which the company claims is “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 USA as well as patients formerly enrolled in the ECAP study, a Saluda press release notes.
Evoke’s MRI labelling is “one of the most comprehensive in the SCS space”, the release further states, providing patients implanted with the 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, according to Saluda. 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. “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 [investigational device exemption] 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.”
The Evoke system provides physiologic, evoked compound action potential (ECAP)-controlled closed-loop SCS therapy, and is indicated as an aid in the management of 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.