Vesalio has announced the recent presentation of key findings from the CLEAR study—a prospective, multicentre, open-label, single-arm, US Food and Drug Administration (FDA)-regulated investigational device exemption (IDE) trial evaluating the safety and effectiveness of the company’s Neva thrombectomy device, which is intended to facilitate retrieval of all clot types in large vessel occlusion (LVO) stroke.
Primary results from CLEAR were delivered at the 2023 European Society of Minimally Invasive Neurological Therapy (ESMINT) congress (4–6 September, Marseille, France) by Serdar Geyik (Istanbul Aydın University, Istanbul, Turkey).
Since the Neva launch across CE-regulated markets in 2018, several academic publications have highlighted the device’s safety and its association with high first-pass recanalisation rates—widely accepted as a consistent predictor of positive patient outcomes.
And, now, the results of the CLEAR study have affirmed the safety and effectiveness of Neva, demonstrating promising first-pass rates and patient outcomes in line with previous publications.
According to Vesalio, the CLEAR study showed excellent clinical outcomes, with nearly two out of three patients treated being functionally independent at 90-day follow-up. Safety results indicated that trial participants experienced low complication rates and mortality as well.
“The prospective CLEAR study confirms the value and differentiation of the Neva device compared to other stent retrievers for achieving rapid and effective revascularisation,” said Geyik. “The results represent a step forward for improving patient outcomes after thrombectomy.”
The CLEAR study has been submitted to the FDA for clearance of the Neva device, which is now pending with the US regulator. The Neva device has been available throughout Europe and other international markets for five years, where it is indicated in LVO stroke, a Vesalio press release notes.
While endovascular clot removal is established as the gold-standard treatment for LVO stroke, conventional stent-retriever technology has proven unsuccessful when patients present with large, hard clot varieties, Vesalio also claims—adding that, in contrast, Neva’s Drop Zone technology has been designed to extract all clot types, addressing a “significant unmet clinical need” for patients.
“The results of the CLEAR study are no surprise to stroke teams who have access to our technology in CE-accepting markets,” said Diane Tangun, vice president of Market Development at Vesalio. “We want to thank physicians for recognising the added value of Neva and making it part of their neurointerventional arsenal.”
This year’s ESMINT congress also saw Vesalio celebrate the fifth anniversary of Neva’s international commercialisation.
“The fifth anniversary of Neva’s commercialisation marks a significant milestone for the neurointerventional space, as our innovation has benefitted nearly 10,000 patients worldwide since the device’s launch,” Tangun added. “Thank you to all who have joined our journey. As we advance, we pledge to continue innovating for better patient outcomes.”
Vesalio states in its recent release that the Neva device is currently pending US clearance with the FDA, and is not available for sale in the USA.