Vesalio has announced US Food and Drug Administration (FDA) humanitarian device exemption (HDE) approval for commercialisation of its NeVa VS device, which is indicated for the adjunct treatment of symptomatic cerebral vasospasm following aneurysmal subarachnoid haemorrhage (aSAH).
According to a company press release, this is the first intracranial technology approved for this indication in the USA.
Cerebral vasospasm is a potentially reversible yet life-threatening condition typically peaking 7–10 days after an intracranial haemorrhage caused by aneurysmal rupture. Vasospasm is the most common complication of SAH, with occurrence rates of up to 70% being reported in prior publications, and it is also known to be the leading cause of delayed morbidity and mortality—the release adds.
To address this condition, Vesalio leveraged expertise gained through the development of the NeVa stent retriever for thrombectomy in acute ischaemic stroke. NeVa VS is a proprietary device specifically tailored to the treatment of vasospasm. According to the release, it combines a smooth and continuous architecture, and the deliverability of a stent retriever, with enhanced outward radial force to effectively dilate these critically narrowed vessels.
The VITAL clinical trial, which was recently published in the Journal of NeuroInterventional Surgery, confirms NeVa VS to be a safe treatment for these patients. Successful treatment of vasospasm was achieved in 92.2% of subjects and 86.5% of treated vessel segments. In a post hoc analysis of the VITAL trial data, the average treatment effect improved the degree of narrowing from 65.6% before treatment to 29.4% on average after treatment with NeVa VS.
Investigators commented that the controlled expansion and maintenance of distal blood flow during the procedure were, in their opinion, distinct advantages of NeVa VS when compared to balloon angioplasty. Use of balloon angioplasty is still an off-label treatment of choice for severe refractory vasospasm and is associated with a high degree of procedural complications, most concerning of which is vessel rupture, the release continues. There were no instances of vessel injury or rupture associated with the use of NeVa VS in the VITAL study.
The clinicians involved in the VITAL study also concluded NeVa VS to be a safe strategy to regain vessel diameter in severely narrowed proximal intracranial arteries secondary to vasospasm associated with aSAH.
“We are extremely proud to obtain this US FDA approval with a device designed to be an ideal solution in this severe condition,” said Vesalio CEO Steve Rybka. “Vesalio has remained committed to working with the FDA to provide an approved solution for physicians treating this underserved patient population. This is a significant milestone in our drive to provide innovative, first-to-market technologies that improve the care of patients with vascular disease.”