Aurenar Wins FDA Breakthrough Designation for V-Link

Key Takeaways

• The FDA granted Breakthrough Device Designation to Aurenar’s V-Link System for adults with aneurysmal subarachnoid hemorrhage as an ICU adjunct intended to reduce cerebral vasospasm.
• V-Link remains investigational while development, commercialization planning, and evaluation of broader neuromodulation applications continue.

The FDA has granted Breakthrough Device Designation for Aurenar’s V-Link System for adults 22 years and older with aneurysmal subarachnoid hemorrhage. The device is intended as an adjunct to ICU clinical management to reduce the incidence of cerebral vasospasm.

V-Link is a non-invasive neuromodulation device that delivers low-energy electrical stimulation to a branch of the vagus nerve through the outer ear. Aurenar describes the approach as transauricular vagus nerve stimulation within a platform designed for patients receiving intensive care.

In a randomized clinical trial of 27 patients with subarachnoid hemorrhage, the therapy reportedly reduced moderate-to-severe vasospasm by more than 40% and was associated with improved patient outcomes. There were no associated adverse events in the trial, and a companion analysis found a 20% decrease in 30-day hospitalization costs directly linked to the method.

V-Link remains investigational and is not approved or cleared by the FDA for commercial distribution as Aurenar advances development, commercialization, and evaluation of additional platform applications.