ONWARD’s ARC-IM for Spinal Cord Injury Patients Named Breakthrough Device
Dutch-Swiss device manufacturer Onward has received Breakthrough Device status from the FDA for its ARC-IM platform for blood pressure and trunk control in people with spinal cord injury.
ARC-IM consists of an implantable pulse generator and lead that is placed near the spinal cord and is operated by a tablet programmer and a smartwatch. It can help long-paralyzed people with spinal cord injury stand and walk again with little or no assistance and can normalize their blood pressure.
The company notes this is the third Breakthrough Device designation it has received. It previously won breakthrough status for its ARC-EX for upper extremity function and its ARC-IM for mobility.