ANACONDA Biomed’s CE Mark approval for the ANA5 Funnel Catheter marks a significant advancement in stroke care, introducing a novel approach to mechanical thrombectomy for acute ischemic stroke. The ANA5 device is engineered with a proprietary funnel-shaped design that matches vessel diameter, enabling enhanced clot capture, flow arrest, and the potential for flow reversal. This innovation aims to improve first-pass success rates and streamline clot retrieval, setting a new benchmark for device performance in thrombectomy procedures.

The ANA5’s clinical promise is supported by robust preclinical and clinical evidence, including the ANAIS study, which demonstrated high reperfusion efficacy and strong first-pass results. Further validation is ongoing in the ATHENA trial—a multicenter, randomized study designed to evaluate the impact of proximal flow arrest on treatment outcomes. These trials collectively underscore the system’s ability to address key challenges in current stroke interventions, including incomplete clot removal and variable procedural efficiency.

This regulatory milestone not only allows the ANA5 to enter clinical use across Europe but also reinforces ANACONDA Biomed’s mission to improve outcomes for stroke patients through precision-engineered tools. By optimizing clot removal and reducing treatment time, the ANA5 Funnel Catheter has the potential to elevate standards in neurointervention, reduce disability, and ultimately save lives. As the company continues to gather real-world data, ANA5 could pave the way for global adoption and future approvals in the U.S. and beyond.

MedTech Spectrum's Summary

Innovative Design for Enhanced Clot Retrieval: The ANA5 Funnel Catheter features a proprietary vessel-matching funnel geometry that improves clot capture, enables antegrade flow arrest, and facilitates aspiration-assisted thrombectomy—advancing mechanical stroke treatment precision.

Strong Clinical Validation and CE Mark Approval: Backed by preclinical studies and promising results from the ANAIS trial, the device has achieved CE Mark certification, clearing the path for clinical adoption across Europe and signaling its potential for broader regulatory approvals.

Elevating Stroke Care Standards: By enabling more effective, first-pass clot removal, ANA5 aims to reduce treatment time and improve outcomes for ischemic stroke patients, positioning ANACONDA Biomed as a key innovator in neurointervention.