Vesalio’s NeVa VS Stent Receives Humanitarian Device Exemption Approval to Treat Cerebral Vasospasm After aSAH

September 15, 2022—Vesalio announced FDA approval under a humanitarian device exemption for the commercialization of the NeVa VS retrievable nitinol stent. The intracranial Neva VS device is indicated for the adjunct treatment of symptomatic cerebral vasospasm (CV) after aneurysmal subarachnoid hemorrhage (aSAH).

In the press release, Vesalio stated that to address CV, the company leveraged expertise gained through the development of the NeVa stent retriever for thrombectomy in acute ischemic stroke. NeVa VS is specifically designed for the treatment of vasospasm. The device 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.

According to the company, results of the VITAL clinical trial confirmed that the device was a safe treatment for these patients. Rishi Gupta, MD, et al recently published the VITAL findings in Journal of Neurointerventional Surgery (2022;14:815-819). In VITAL, successful treatment of vasospasm was achieved in 92.2% of patients and 86.5% of treated vessel segments.

Vesalio stated that a post hoc analysis of the VITAL trial data showed that the average treatment effect improved the degree of narrowing from 65.6% before treatment to 29.4% after treatment with NeVa VS. The VITAL investigators opined that the controlled expansion and maintenance of distal blood flow during the procedure were distinct advantages of the NeVa VS when compared to balloon angioplasty.

As noted in the press release, 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. There were no instances of vessel injury or rupture because of the use of the NeVa VS in the VITAL study.

The VITAL investigators concluded that NeVa VS is a safe strategy to regain vessel diameter in severely narrowed proximal intracranial arteries secondary to vasospasm associated with aSAH, reported Vesalio.