Nashville, TN, April 28, 2021, Vesalio announces it has accomplished a key FDA IDE study milestone to support entry into the US neurovascular market. Enrollment in the VITAL1 clinical trial, assessing the company’s NeVa VS™ technology in the treatment of symptomatic cerebral vasospasm following aneurysmal subarachnoid hemorrhage (aSAH), has been completed.
Cerebral vasospasm is an intense and prolonged narrowing of the arteries that develops gradually over the first few days following aneurysm rupture. This narrowing can reduce blood flow and is considered to be one of the leading causes of death after such ruptures. Current treatment for vasospasm includes endovascular administration of intra-arterial vasodilators and balloon angioplasty, utilized off-label for this indication. Currently, there is no medical technology cleared for the treatment of vasospasm in the United States.
“Completion of this IDE study is a significant step forward in our drive to provide the first FDA cleared technology to treat this patient population. We look forward to working with the FDA in the next step of the regulatory process,” stated Steve Rybka, CEO of Vesalio.
1-VITAL refers to “The Vesalio NeVa VS for the treatment of symptomatic Cerebral Vasospasm following aneurysmal subarachnoid haemorrhage (aSAH)”
Founded in 2013, Vesalio is a privately held medical device company focused on advancing patient care in vascular occlusion by providing physicians superior technology designed to improve clinical outcomes. The Company’s proprietary NeVa™ platform was designed to consistently achieve first-pass recanalization in acute ischemic stroke by effectively removing all types of neurovascular clots from patient anatomy.