Vesalio initiates new FDA stroke study following “milestone” VITAL trial enrolment


vesalioUS medical device company Vesalio has announced the start of enrolment in the Vesalio CLEAR study—an acute ischaemic stroke FDA investigational device exemption (IDE) clinical trial to utilise its NeVa thrombectomy technology platform. Enrolment across 20 participating stroke treatment centres is expected to be completed in early 2022.

The CLEAR 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 large vessel occlusion (LVO) stroke. In a press release, Vesalio described the commencement of enrolment in this trial as “another key milestone” supporting its entry into the US neurovascular thrombectomy market.

“There have been more than 3,200 stroke patients treated with the NeVa thrombectomy platform in Europe and other global markets,” said Vesalio CEO Steve Rybka. “The recanalisation results have been impressive with high first-pass efficacy across the entire spectrum of clot types. We are excited to more definitively demonstrate the excellent performance and first-pass success of NeVa in the FDA IDE CLEAR study.”

This news follows another announcement from Vesalio in April 2021—that being the completion of patient enrolment in its VITAL clinical trial, which is assessing the company’s NeVa VS technology in the treatment of symptomatic cerebral vasospasm following aneurysmal subarachnoid haemorrhage (aSAH).

“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,” Rybka added. “We look forward to working with the FDA in the next step of the regulatory process.”

According to a Vesalio press release, there is no medical technology currently cleared for the treatment of cerebral vasospasm—an intense and prolonged narrowing of the arteries following aneurysm rupture—in the USA and, as such, the company hopes to further support its entry into the American neurovascular market with the VITAL study.


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