Vesalio’s NeVa Thrombectomy Device Assessed in CLEAR Study

Vesalio announced findings from CLEAR, which is an FDA-approved investigational device exemption study to assess the safety and efficacy of the company’s NeVa thrombectomy platform in the treatment of acute ischemic stroke.

The NeVa stent retriever, which features the company’s Drop Zone technology, is designed to retrieve all clot types in large vessel occlusion (LVO) stroke.

The primary results from the prospective, open-label, multicenter, single-arm study were presented by Professor Serdar Geyik, MD, at ESMINT 2023, the 15th congress of the European Society Minimally Invasive Neurological Therapy held September 4-6 in Marseille, France.

“The prospective CLEAR study confirms the value and differentiation of the NeVa device compared to other stent retrievers for achieving rapid and effective revascularization,” commented Dr. Geyik in Vesalio’s press release. “The results represent a step forward for improving patient outcomes after thrombectomy.”

The CLEAR trial data have been submitted to FDA for clearance of the NeVa device, which is now pending.

According to the company, the results affirmed the safety and effectiveness of NeVa with promising first-pass rates and patient outcomes that were in line with previous published data. CLEAR also showed excellent clinical outcomes, with approximately two of three treated patients functionally independent at 90-day follow-up. In terms of safety, patients in the trial experienced low complication rates and mortality.

Also, at ESMINT, the company also marked the fifth anniversary of NeVa’s international commercialization. In September 2018, the company announced that the NeVa device was available in Europe and other international markets, where it is indicated in LVO stroke.

Neurointerventional news coverage produced in conjunction with Endovascular Today.