Onward Medical has received FDA approval to begin a pivotal study of its Arc-IM system, an implantable neurostimulation therapy designed to treat blood pressure instability after spinal cord injury, according to an Aug.18 news release.
The condition affects more than half of people with SCI and can severely impact recovery, cardiovascular health and quality of life.
The randomized, double-blind, sham-controlled trial will enroll patients at about 20 neurorehabilitation and neurosurgical centers in the U.S., Canada and Europe. First enrollment is expected before the end of the year. Participants will include people with cervical and upper thoracic SCI who experience chronic orthostatic hypotension or episodes of autonomic dysreflexia, according to the release.
This marks Onward’s second global pivotal study and the first to test the Arc-IM technology.
