FDA Grants Breakthrough Device Designation to Aurenar's Investigational V-Link System for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage
KEY TAKEAWAYS
- The FDA granted Breakthrough Device Designation to the investigational V-Link system for reducing cerebral vasospasm in adults with aneurysmal subarachnoid hemorrhage receiving ICU care.
- The designation is intended to facilitate FDA interactions and accelerate development and review but does not constitute marketing authorization.
- Early randomized clinical trial findings showed reduced moderate-to-severe vasospasm without device-related adverse events, supporting further clinical development.
The Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the V-Link System (Aurenar, St. Louis, MS), an investigational, noninvasive transauricular vagus nerve stimulation (taVNS) device being developed as an adjunct to standard clinical management to reduce the incidence of cerebral vasospasm in adults aged 22 years and older with aneurysmal subarachnoid hemorrhage during intensive care. Cerebral vasospasm is a major contributor to secondary brain injury, disability, and death following aSAH, and there are currently no FDA-approved device therapies designed to prevent this complication.
The FDA's Breakthrough Devices Program is intended to expedite the development and regulatory review of medical devices that may offer more effective treatment for life-threatening or irreversibly debilitating conditions. According to Aurenar, the designation provides priority engagement with the FDA as the company advances V-Link through pivotal clinical development and the premarket review process. V-Link is a wireless, noninvasive device that delivers low-energy electrical stimulation to a branch of the vagus nerve through the outer ear with the goal of modulating inflammatory pathways implicated in secondary brain injury after hemorrhagic stroke.
What the Early Data Showed
- In a randomized clinical trial of 27 participants with subarachnoid hemorrhage, taVNS reduced moderate-to-severe cerebral vasospasm by more than 40%, according to the company.
- Investigators reported no associated adverse events related to the therapy.
- A companion analysis found a 20% reduction in 30-day hospitalization costs associated with the treatment approach.
The company stated that it plans to continue development of V-Link and evaluate additional critical care applications for its neuromodulation platform.
Source
Aurenar. Aurenar Receives FDA Breakthrough Device Designation for Non-Invasive Neuromodulation Therapy Designed for the Reduction of Cerebral Vasospasm Following Brain Hemorrhage. PR Newswire. Published June 30, 2026. Accessed July 6, 2026. https://www.prnewswire.com/news-releases/aurenar-receives-fda-breakthrough-device-designation-for-non-invasive-neuromodulation-therapy-designed-for-the-reduction-of-cerebral-vasospasm-following-brain-hemorrhage-302813829.html