ONWARD Medical’s ARC-EX System Receives the European CE Mark Approval for Spinal Cord Stimulation
Shots:
- ONWARD Medical has received MDR CE Mark approval for its ARC-EX system to treat people with spinal cord injury (SCI); first EU commercial sales are expected by Q4’25
- Approval was backed by extensive clinical data, incl. Up-LIFT trial published in Nature Medicine, showing 90% pts improved strength or function, 87% reported better QoL, & benefits lasting ~34yrs. as well as Pathfinder2 study published in Neuromodulation: Technology at the Neural Interface, confirming continued benefit in upper body strength, trunk control, & balance after 1yr. of therapy
- ARC-EX is a non-invasive system that delivers programmed transcutaneous spinal cord stimulation via neck electrodes & improves hand strength & sensation in adults with chronic, incomplete SCI (C2–C8) in conjunction with functional task practice
Ref: ONWARD Medical | Image: ONWARD Medical | Press Release
Related News:- ONWARD Medical Receives FDA IDE Approval for ARC-IM System to Treat Blood pressure Instability in Spinal Cord Injury
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