The breakthrough nod enables the acceleration of the development, assessment and review of the technology for the reduction of cerebral vasospasm in in adults with aneurysmal subarachnoid hemorrhage (aSAH). The designation applies to the use of V-Link in adult patients (22 years of age and older) with aSAH as an adjunct to clinical management to reduce the incidence of cerebral vasospasm while in the ICU.

St. Louis-based Aurenar said the breakthrough nod gives it priority, interactive engagement with FDA reviewers. It also offers a more efficient pathway through the approval process as it works toward pivotal trials and regulatory submissions.