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2026-05-26 00:00 United States Clinical Implantation & Procedure Translated from EN

Onward Medical Implants First Participant in Empower BP Pivotal Trial

阶段关键性试验适应症脊髓损伤
Summary Onward Medical said the first participant in its global Empower BP pivotal study was enrolled and implanted with the investigational ARC-IM system at Craig Hospital in Denver during the first quarter of 2026. The randomized, double-blind, sham-controlled trial is evaluating management of blood-pressure instability after spinal cord injury across about 20 planned centers. Empower BP is not an upper-limb BCI trial, and the first implant did not take place in the Netherlands.
Why it matters Empower BP moves implantable spinal stimulation into a global pivotal test of autonomic function, with the sham-controlled blood-pressure outcome as the key evidence.
BCIwiki (bciwiki.com) — Onward Medical reported on May 26, 2026, that the first participant in its global Empower BP pivotal study had been enrolled and implanted with the investigational ARC-IM system during the first quarter. The procedure took place at Craig Hospital in Denver, Colorado.

Empower BP is evaluating the safety and effectiveness of implantable spinal cord stimulation for managing blood-pressure instability after spinal cord injury. The randomized, double-blind, sham-controlled study is expected to involve about 20 neurorehabilitation and neurosurgical research centers in the United States, Canada, France, Germany, Spain and the United Kingdom. Twelve U.S. sites were active and recruiting when the update was released.

ARC-IM remains investigational and is not available for commercial use. Onward Medical separately develops ARC-BCI, which pairs a BCI with spinal stimulation to restore movement. Empower BP is not that upper-limb restoration program, and its first implant did not take place in the Netherlands.

Compiled by BCIwiki from public sources

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2025-09 Onward Medical ARC-EX system receives CE mark All entries →
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