Anaconda Biomed, a company specialising in thrombectomy systems, has secured CE mark certification for its ANA5 Funnel Catheter to treat ischemic stroke.
The CE mark confirms the device’s compliance with European Union health, safety, and environmental standards, paving the way for its commercialisation across the EU.
The ANA5 Funnel Catheter is engineered to optimise mechanical thrombectomy by maximising clot capture with its vessel-matching diameter funnel.
It allows for antegrade flow arrest and potential flow reversal, enhancing aspiration-assisted clot retrieval, and its proprietary geometry promotes improved clot capture and removal.
Anaconda Biomed CEO Trent Reutiman said: “Receiving CE Mark approval is a pivotal achievement for Anaconda Biomed that advances our mission to innovate in the interventional management of acute ischemic stroke.
“This milestone reflects the strength of our science and the dedication of our team. We now have the capability of making ANA5 available to clinicians across Europe, bringing this innovative technology to broader stroke application.”
The CE mark approval is based on extensive evidence, including preclinical bench and animal studies, and clinical data from the ANAIS study, which shows high reperfusion and first-pass success rates.
Further clinical validation is underway in the ATHENA trial, a multicentre randomised study evaluating the impact of proximal flow arrest on reperfusion effectiveness, supporting future regulatory submissions and commercialisation in the US.
The ANA5 Advanced Neurovascular Access (ANA Funnel Catheter) is designed for interventional neurovascular procedures requiring clot retrieval.
It features an expandable and collapsible funnel with a radiopaque nitinol braid, covered with a polymeric coating to enable local flow arrest.
Anaconda Biomed co-founder Marc Ribo said: “Receiving CE mark approval for ANA5 is deeply meaningful, as it represents the culmination of years of research, iteration, and belief in an idea that began at the bench.
“This is more than a regulatory milestone; it’s the moment where innovation becomes impact. We’re now gearing up to capture real-world data by collecting more invaluable insight into how ANA5 performs across diverse stroke centres and clinical realities.”
