The US Food and Drug Administration (FDA) has granted breakthrough device designation to Aurenar’s V-Link system for cerebral vasospasm treatment in adults following stroke.
Cerebral vasospasm, a key mechanism of delayed cerebral ischemia (DCI), is a common complication wherein blood vessels in the brain constrict in the days following an aneurysmal subarachnoid haemorrhage (aSAH) stroke, causing reduced blood flow associated with additional injury.
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Aurenar’s V-Link system delivers electrical stimulation to the vagus nerve via the outer ear to address the complication. This treatment modality is designed to help regulate the body’s inflammatory response, which plays a significant role in the secondary brain injury that can occur after a haemorrhagic stroke, according to the Missouri-based company.
As per the breakthrough tag, the designation is for the system’s use alongside clinical management to reduce the incidence of cerebral vasospasm while patients are in intensive care.
“Breakthrough device designation is an important validation of both the science behind V-Link and the urgency of the problem it addresses,” said Aurenar CEO Dr Eric Leuthardt.
“Families watch helplessly as vasospasm threatens patients who have already survived a devastating haemorrhage. This designation lets us work together with the FDA to bring a non-invasive therapy to these patients as efficiently and responsibly as possible.”
The current standard of care (SoC) for treating cerebral vasospasm is the administration of oral nimodipine, a dihydropyridine calcium-channel blocker that prevents and mitigates DCI following aSAH by compensating for decreased blood flow and shielding the brain from ischemic damage. Other treatment strategies for the complication include rescue interventions such as balloon angioplasty to mechanically dilate the affected proximal blood vessels.
Research indicates that cerebral vasospasm occurs in 40%-70% of aSAH patients, yet there are currently no FDA-cleared devices for its treatment. V-Link’s development originated from research led by Aurenar’s co-founder and CMO, Dr Anna Huguenard, and Dr Leuthardt at WashU Medicine.
In a randomised clinical trial of V-Link involving 27 patients with subarachnoid haemorrhage, the neuromodulation therapy reduced moderate-to-severe vasospasm by over 40% and was associated with improved patient outcomes, with no associated adverse events.
Commenting on the breakthrough designation, Dr Huguenard said: “Vasospasm has frustrated the neurocritical care community for generations, and our trial data suggest that modulating inflammation through the vagus nerve has the potential to meaningfully change that trajectory.
“Earning this designation reflects the positive clinical signal we’ve seen and moves us closer to a tool clinicians can use at the bedside.”
