Advertisement
Advertisement
May 12, 2022
Vesalio Completes Enrollment in CLEAR FDA IDE Study for Acute Ischemic Stroke
May 12, 2022—Vesalio announced that it has completed patient enrollment for CLEAR, an FDA investigational device exemption study to assess the safety, performance, and efficacy of the company’s NeVA thrombectomy platform in the treatment of acute ischemic stroke (AIS).
CLEAR is a prospective, open-label, multicenter, single-arm trial, noted the company.
Using Vesalio’s proprietary Drop Zone technology, NeVA is designed to consistently achieve first-pass recanalization in patients with AIS by effectively removing all types of neurovascular clots from a patient’s anatomy, including large and hard thrombus, to treat patients with AIS. It has been used for AIS in > 4,500 procedures in Europe and other global markets.
“During a thrombectomy procedure for AIS, 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,” Steve Rybka, CEO of Vesalio.
He continued, “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.”
Advertisement
Advertisement
