Vesalio has announced the completion of patient enrolment for the CLEAR US Food and Drug Administration (FDA) investigational device exemption (IDE) study utilising the NeVa thrombectomy platform.
In a press release, Vesalio states that this is an important milestone for the company to have achieved as it looks to enter the US neurovascular market and treat patients suffering from acute ischemic stroke.
The NeVa thrombectomy platform utilises Vesalio’s proprietary Drop Zone technology, which is designed to remove different clot types including large and hard thrombus, providing a “much-needed solution” for physicians treating patients suffering from this debilitating, life-threatening condition. NeVa has been used for acute ischaemic stroke in more than 4,500 procedures in Europe and other global markets to date, according to the company.
“During a thrombectomy procedure for acute ischaemic stroke, the treating physician cannot ascertain the type of clot they will encounter. A thrombectomy device that can manage all clot types would contribute substantially to a doctor’s treatment arsenal,” said Steve Rybka, CEO of Vesalio. “Completion of this IDE study is a significant milestone in our mission to improve outcomes in this patient population. We look forward to working with the FDA in the next steps of the regulatory process.”
The CLEAR clinical study is a prospective, open-label, multicentre, single-arm trial designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of acute ischaemic stroke.