Feasibility data published in 2025 reported immediate, sustained increases in blood pressure with implant-based spinal cord stimulation in people with chronic spinal cord injury, alongside reductions in hypotensive symptoms, improved tolerance of upright posture, and decreased reliance on compression garments and medications, with benefits maintained for up to two years. Those signals set the backdrop for a pivotal test of whether these effects hold under sham control and across a broader, multinational population.
ONWARD Medical has enrolled the first participant in Empower BP, a global, randomized, double-blind, sham-controlled pivotal study of its implantable ARC-IM system for symptomatic blood pressure instability after chronic spinal cord injury. The trial plans to run at approximately 20 neurosurgical and neurorehabilitation centers in the US, Canada, France, Germany, Spain, and the UK, targeting individuals with injuries from C2 to T6 and severities AIS A through D. The system pairs an implanted neurostimulator with a thoracic lead positioned over segments with high densities of neurons involved in blood pressure regulation. The initial enrollment occurred at Craig Hospital in Denver.
Strategically, this is ONWARD’s move to expand from its already commercial external platform into an implantable modality aimed at autonomic dysfunction—an area with high unmet need and limited effective options beyond pharmacologic and mechanical management. A global pivotal at this stage signals intent to harmonize expectations between FDA and European regulators and to lean on prior Breakthrough Device designations to clarify endpoints and review timelines. The study’s blinding and sham design are notable in an implant context and will be central to establishing credible effect size and durability under regulatory scrutiny.
For sites, Empower BP brings a combined neurosurgical and autonomic care workflow: precise thoracic lead placement, intra- and post-operative hemodynamic testing, standardized programming, and longitudinal capture of orthostatic symptoms and activities of daily living. Maintaining blinding around stimulation parameters and any crossover provisions will add operational complexity, as will coordinating home blood pressure monitoring and symptom diaries typical of this indication. CROs and vendors will need to support multi-country device logistics, calibration and servicing, data quality around continuous or episodic BP measures, and coherent training across rehab and surgical teams. Regulators will be focused on how “hemodynamic stability” is defined and measured, the clinical meaningfulness of symptom reduction, and the reproducibility of feasibility signals across heterogeneous injury levels. Payers will look for reductions in acute care utilization from autonomic dysreflexia and syncope, decreased medication burden, and improved rehabilitation participation to justify an implant procedure.
Key watch points include the primary endpoint definition, adjudication of symptomatic episodes, time-in-target hemodynamic range, and durability windows prespecified in the protocol. Safety will carry equal weight: perioperative complications, arrhythmias, unintended autonomic effects, and device-related adverse events will factor into benefit-risk. Enrollment pace and screen-failure rates across AIS categories and injury levels will reveal the practical addressable population and the need for stratification. If the trial is positive, attention shifts quickly to regulatory filing sequence, programming standardization for real-world use, and reimbursement strategy, including DRG placement and outpatient coding. The central risk is whether a sham-controlled effect justifies implantation versus lower-cost conservative care, particularly across diverse centers. Consistency of programming across sites, supply chain readiness for a neuromodulation implant, and the ability to replicate feasibility magnitude under double blinding will determine how quickly this therapy can move from pivotal success to routine practice.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
