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Spinal Implant Stabilizes Blood Pressure After Spinal Cord Injury, Paving Way for Pivotal Trial

FDA clearance follows multicenter studies showing rapid, consistent blood pressure control.

Overview

  • Peer-reviewed publications in Nature and Nature Medicine report outcomes from 14 participants across four studies at centers in Canada, Switzerland, and the Netherlands.
  • Researchers mapped the spinal circuits that trigger autonomic dysreflexia and identified the lower thoracic hemodynamic hotspot for precise stimulation.
  • The system uses new electrode arrays and a pacemaker-like pulse generator, controllable via an app, to deliver individualized epidural stimulation.
  • Activation restored blood pressure to a functional range within minutes across sites, with participants reporting clearer thinking, more energy, louder speech, and fewer postprandial dips.
  • Clinicians reported a favorable safety profile and successful deployment across settings, and ONWARD Medical received FDA approval to start a pivotal trial at about 20 centers in Canada, Europe, and the United States.