Shots:
- ONWARD Medical has received the US FDA IDE approval to initiate its Empower BP study evaluating ARC-IM System for blood pressure instability in spinal cord injury
- The IDE trial will assess ARC-IM System in pts with C2–T6 spinal cord injuries, injury severities of AIS A-D & blood pressure instability, incl. chronic OH & autonomic dysreflexia, across ~20 centers in the US, Canada, & EU, with first enrollment expected by 2025 end
- ARC-IM System, comprising an implanted ONWARD Neurostimulator (IPG) and ARC-IM Thoracic Lead, is a neuroprosthetic platform designed to manage blood pressure instability in SCI pts by delivering targeted spinal cord stimulation at the “Hemodynamic Hotspot”
Ref: ONWARD Medical | Image: ONWARD Medical | Press Release
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