FDA Breakthrough Device Targets Brain Hemorrhage Complications

This secondary narrowing of blood vessels can worsen ischemic injury, increase disability, and add to healthcare resource use. Yet noninvasive options to blunt the inflammatory cascade that precedes vasospasm remain limited. To help address this need, a neuromodulation technology has received expedited U.S. Food and Drug Administration (FDA) review for use after aneurysmal brain hemorrhage.

Aurenar’s V-Link System, developed from research at Washington University School of Medicine in St. Louis, has received Breakthrough Device Designation from the FDA. The designation provides an accelerated pathway toward market authorization for technologies with the potential to improve care for severe or life-threatening conditions. The device is designed to help prevent delayed vascular complications following aneurysmal subarachnoid hemorrhage.

V-Link delivers low‑energy electrical pulses to the outer ear to activate the transauricular branch of the vagus nerve. The approach is designed to reduce the acute inflammatory response that contributes to vasospasm and secondary injury. If cleared, treatment would consist of 20‑minute sessions twice daily during the typical two‑week intensive care unit (ICU) stay.

Early clinical trials led at Barnes‑Jewish Hospital evaluated this strategy in 27 patients with aneurysmal subarachnoid hemorrhage. Stimulation reduced inflammation and mitigated serious complications, including a 40% reduction in vasospasm, with no adverse events. Compared with standard care, treated patients had lower cytokine levels in blood and cerebrospinal fluid and, at 90 days, less disability and lower rates of hospital readmission or discharge to a skilled nursing facility.

An additional health economic analysis in collaboration with Barnes‑Jewish Hospital associated the intervention with reduced costs, driven by fewer complications, shorter hospitalizations, and fewer readmissions. A second clinical trial in patients with large‑vessel‑occlusion stroke found that ear stimulation correlated with lower inflammatory markers and reduced disability compared with standard care. These findings support continued evaluation of noninvasive vagus‑nerve stimulation as a critical‑care adjunct following brain hemorrhage.

“Stroke is not only the second-leading cause of death, but also a significant contributor to long-term disability. The noninvasive device shows promise in reducing complications and improving outcomes in critically ill patients. Furthermore, we have promising evidence that the intervention reduces intensive care unit (ICU) costs,” said Eric Leuthardt, MD, the Shi Hui Huang Professor of Neurological Surgery at WashU Medicine and founder and CEO of Aurenar.

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