Nashville, Tennessee - (Sept 15, 2022) – Vesalio announces FDA HDE approval for commercialization of NeVa VS, indicated for the adjunct treatment of symptomatic cerebral vasospasm (CV) following aneurysmal subarachnoid hemorrhage (aSAH), the major cause of death and disability in this patient population. This is the first intracranial technology approved for this indication in the U.S.
NeVa VS is a patented retrievable nitinol stent specifically designed to treat cerebral vasospasm after aneurysmal rupture. Delayed cerebral vasospasm is the leading cause of death and disability in patients who suffer an aneurysm rupture.
CV is a potentially reversible life-threatening condition typically peaking 7 to 10 days after an intracranial hemorrhage caused by aneurysmal rupture (SAH). Vasospasm is the most common complication of SAH with occurrence rates of up to 70% according to publications. It is also known to be the leading cause of delayed morbidity and mortality.
To address this deadly condition, Vesalio leveraged expertise gained through the development of the NeVa™ stent retriever for thrombectomy in acute ischemic stroke. The NeVa VS is a proprietary device specifically tailored to the treatment of vasospasm. The NeVa VS 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, recently published in the Journal of Interventional 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 (1). Investigators commented that the controlled expansion and maintenance of distal blood flow during the procedure were, in their opinion, distinct advantages of the NeVa VS when compared to balloon angioplasty (1). 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 due to the use of the NeVa VS in the VITAL study.
“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. The clinicians involved in the VITAL study concluded NeVa VS to be a safe strategy to regain vessel diameter in severely narrowed proximal intracranial arteries secondary to vasospasm associated with aSAH. “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.”
Founded in 2017, Vesalio is a privately held medical device company focused on advancing patient care in vascular occlusion by providing physicians with superior technology designed to improve clinical outcomes. Vesalio’s proprietary NeVa™ platform is designed to consistently achieve first-pass recanalization in acute ischemic stroke by effectively removing all types of neurovascular clots from a patient’s anatomy. For more information, visit vesalio.com .