ONWARD has received Breakthrough Device Designation status from the US Food and Drug Administration (FDA) for its ARC-IM platform for blood pressure and trunk control in people with spinal cord injury, it announces.
This is the third such Breakthrough Device Designation awarded to ONWARD, following previous awards for ARC-EX for upper extremity function and ARC-IM for mobility, the medical technology company notes in a media release.
Pulse Generator
ARC-IM consists of an implantable pulse generator and lead that is placed near the spinal cord. The system is operated via a tablet programmer and smartwatch.
The STIMO study demonstrated the ability of this technology to enable long-paralyzed people to stand and walk again with little or no assistance. A recently published study in Nature suggests the potential for this same therapy to normalize blood pressure in people with spinal cord injury.
“Blood pressure and trunk control are two of the many challenges people with spinal cord injury must manage in order to navigate their daily lives. We are excited about this award and thankful to the FDA for recognizing the potential of our technology to improve the quality of life for those with spinal cord injury.”
— Dave Marver, Chief Executive Officer of ONWARD
Breakthrough Designation
Breakthrough Device Designation is an FDA program designed to help patients and their physicians receive timely access to technologies that have the potential to provide more effective treatment or diagnosis for debilitating conditions of great unmet need, such as spinal cord injury.
As part of this designation, the FDA will provide ONWARD with priority review and the opportunity to interact with FDA’s experts throughout the premarket review phase as the technology moves toward eventual commercialization.
[Source(s): ONWARD, Business Wire]
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