The US Food and Drug Administration (FDA) has granted 510(k) clearance for the expanded use of Onward Medical’s ARC-EX System, now permitting individuals with spinal cord injuries (SCI) to use the device at home, as well as in clinical settings.
This cleared indication covers adults with long-standing, non-progressive neurological impairments originating from an incomplete SCI, aiming to enhance hand strength and sensation through both supervised rehabilitation and home exercise routines.
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The non-invasive system works through transcutaneous electrical stimulation of the spinal cord.
It is designed for operation by healthcare professionals in rehabilitation centres, as well as by patients or their caretakers in a home environment.
Onward Medical CEO Dave Marver said: “Today’s authorisation expanding the ARC-EX System indication for home use greatly enlarges the US market opportunity and is a defining milestone for the spinal cord injury community.
“People living with SCI will now be able to benefit from use of the ARC-EX System in the comfort and convenience of their own homes.”
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By GlobalDataVarious clinical outcomes support ARC-EX Therapy’s use; data from the Up-LIFT pivotal trial demonstrated that 90% of subjects experienced gains in function or strength while 87% noted an improved quality of life.
These effects were seen even in those whose injuries dated back as far as 34 years. Subjects also reported better sleep, improvements in upper body sensation and touch perception, and fewer muscle spasms.
Further findings from the Pathfinder2 Study indicated that the combination of ARC-EX Therapy with activity-based rehabilitation produced continuing functional improvements over a one-year period, without diminishing returns.
Outcomes from the LIFT Home Study indicated that ARC-EX Therapy’s ongoing at-home use helped sustain and build upon progress achieved during clinic treatment.
Having been commercially available for less than 12 months, the system is now offered in over 60 US clinics.
The device holds regulatory clearance for sale in both the US and European markets.
