This week, the FDA granted revolutionary device designation for MarriageThe V-Link System, a non-invasive nerve stimulation device designed to treat cerebral vasospasm.
Vasospasm is one of the most dangerous complications that can occur after a brain hemorrhage. This happens when blood vessels in the brain narrow in the days after an aneurysm, cutting off blood flow to the brain tissue and potentially causing additional, usually serious, damage beyond the initial bleeding. This disease affects a large proportion of patients who survive a brain hemorrhage: they survive the initial event, only to suffer additional brain damage, sometimes worse, a few days later.
Historically, providers lacked tools to prevent vasospasm. The main option is oral medication, supported by invasive salvage procedures like balloon angioplasty.
Aurenar’s V-Link aims to intervene earlier. Instead of waiting to intervene after the vessels have constricted, the earpiece-like device delivers gentle electrical pulses to a nerve behind the ear to calm the body’s inflammatory response, which is the same response believed to cause the spasms.
Patients receive the treatment for 20 minutes twice a day during their stay in the ICU, explained Eric Leuthardt, CEO of Aurenar. The device is designed to fit into existing intensive care unit workflows so nurses and doctors can use it without much training, he added.
In a trial, the V-Link approach reduced moderate to severe vasospasm by more than 40%, with no safety concerns reported.
The trial included only 27 patients, but Leuthardt is confident that the V-Link’s rate of vasospasm reduction will hold up on a large scale.
“The 27-patient trial was a randomized, triple-blind study – meaning the patients, clinicians and outcome assessors were all blinded – which is the strongest study design for a trial of this size. The effect size we observed was substantial and reached statistical significance, and the result was consistent with what we would expect biologically given how vagus nerve stimulation modulates inflammation,” he said. declared.
Yet Aurenar approaches evidence generation with “appropriate humility,” Leuthardt noted. This breakthrough device designation is intended to accelerate the path to larger pivotal trials, which, he noted, are designed precisely to confirm whether the product’s benefits hold up at scale.
Looking ahead, Leuthardt said Aurenar’s near-term goal is to conduct pivotal trials for this specific indication — but the company envisions the same inflammation-modulating mechanism eventually applying to other high-acuity critical care conditions. It is planned, in the long term, to expand the indications, indication by indication.
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