Anaconda Biomed has today announced that it has received CE-mark certification for its ANA5 funnel catheter. The CE marking confirms that the ANA5 device complies with the European Union’s (EU) health, safety and environmental protection standards, enabling its eventual commercial viability across the EU, as noted in a company press release.
“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,” said Anaconda co-founder Marc Ribó (Hospital Vall d’Hebrón, Barcelona, Spain). “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.”
The ANA5 funnel catheter has been engineered to optimise mechanical thrombectomy by maximising clot capture with its vessel-matching diameter funnel. Anaconda’s recent release states that, simultaneously, the device enables antegrade flow arrest and offers the potential for flow reversal, enhancing aspiration-assisted clot retrieval—ultimately promoting improved clot capture and removal through its “unique, proprietary geometry”.
The CE-mark approval of the device is supported by a comprehensive body of evidence, including preclinical bench and animal studies, and clinical data from the recently published ANAIS study demonstrating high reperfusion and first-pass success rates, according to the company.
Further clinical validation of ANA5 is ongoing in the ATHENA trial—a prospective, multicentre, randomised study systematically evaluating the impact of proximal flow arrest on reperfusion effectiveness—to support future regulatory submissions and commercialisation efforts in the USA.
“Receiving CE-mark approval is a pivotal achievement for Anaconda Biomed that advances our mission to innovate in the interventional management of acute ischaemic stroke,” said Trent Reutiman, the company’s chief executive officer (CEO). “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.”
