Aurenar, a Washington University startup received FDA Breakthrough Device designation for its V-Link System, a wearable device designed to improve stroke outcomes after ruptured brain aneurysm.
Aneurysmal subarachnoid hemorrhage occurs when a ruptured brain aneurysm causes bleeding around the brain.
“Stroke is not only the second leading cause of death, but a significant contributor to long-term disability,” said Eric Leuthardt, MD, the Shi Hui Huang Professor of Neurological Surgery at WashU Medicine and founder and CEO of Aurenar. “The non-invasive 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 costs.”
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FDA Breakthrough Device Designation provides an expedited review process for market approval of promising medical technologies. Devices that earn the designation have shown clinical promise in improving the treatment or diagnosis of severe, life-threatening conditions.
In order to help control the body's inflammatory response, which can lead to additional brain damage following hemorrhagic stroke and other serious illnesses, V-Link applies low-energy electrical stimulation to a branch of the vagus nerve via the outer ear.
"Cerebral vasospasm remains a leading cause of disability and death after a subarachnoid hemorrhage, yet the standard of care has changed little in decades and is largely supportive," Dr. Leuthardt, told MobiHealthNews.
Oral nimodipine, the only medication that has been demonstrated to improve outcomes, hemodynamic support in the neuro-ICU to maintain brain perfusion, and invasive endovascular rescue using catheter-delivered vasodilators or balloon angioplasty for refractory cases are the standard treatments for cerebral vasospasm.
"Even with these measures, patients remain at high risk – a substantial proportion still develop vasospasm and go on to suffer permanent disability or death," Leuthardt said.
Single-mechanism medications have rarely worked because it is now recognized that the underlying damage is complex rather than merely large-vessel spasm.
V-Link was developed to fulfill "a profound unmet need for a therapy that is non-invasive, addresses the underlying biology and can be deployed early at the bedside," Leuthardt said.
