ONWARD Medical Secures FDA IDE Green Light for Empower BP Study

ONWARD Medical N.V. has received approval from the US Food and Drug Administration (FDA) for its investigational device exemption regarding the ARC-IM System. This permits the initiation of a global pivotal study, Empower BP, to evaluate the safety and efficacy of the implantable spinal stimulation system aimed at addressing blood pressure instability in spinal cord injury (SCI) patients.

The study represents ONWARD's second global pivotal trial and its first for the ARC-IM System. It will involve around 20 leading centers in the US, Canada, and Europe, focusing on participants with spinal injuries. Blood pressure instability post-SCI significantly affects cardiovascular health and quality of life, representing a critical unmet need.

The ARC-IM System consists of an implanted neurostimulator and a thoracic lead targeting a specific spinal region. It aims to improve spinal cord injury outcomes by managing blood pressure-related complications.