In a recent conversation with MedTech Spectrum, Trent Reutiman, CEO of ANACONDA Biomed, shared insights into the company’s CE Mark approval for the ANA5 Funnel Catheter—a next-generation device designed to improve clot capture and procedural outcomes in acute ischemic stroke treatment. Featuring a vessel-conforming funnel and proximal flow control, the catheter enhances first-pass success during aspiration-based thrombectomy. Backed by positive data from the ANAIS study and further evaluated in the ATHENA trial, ANA5 represents a significant advancement in stroke care across European clinical settings. Reutiman emphasized that this regulatory milestone reinforces ANACONDA Biomed’s mission to deliver precision-engineered neurovascular solutions that enable faster, safer, and more effective interventions for patients when every second counts.
How does the proprietary funnel design of the ANA5 catheter enhance clot retrieval efficiency compared to conventional thrombectomy systems currently in use?
The ANA Funnel Catheter is unique because it is the only catheter with an expandable and collapsible funnel that adapts to the diameter of intracranial arteries. Distal aspiration catheters have been a major advancement because their flexibility allows them to directly face the clot and aspirate. However, they remain fixed-diameter, straw-like solid objects,which imposes limitations. You can increase t heir diameter to make them “more efficient,” but you cannot force these catheters into vessels aggressively, as this raises the risk of vessel trauma or secondary vasospasm due to friction forces. Therefore, there is only so much you can expand and only so much clot volume you can engage. ANA5’s advantages are twofold. First, the distal end of the catheter is a funnel that conforms to the full circumference of the artery where it is deployed. This means that even large clots, hypothetically, with diameters as big as the artery, can potentially be captured entirely by the funnel. Additionally, because the braided nitinol funnel has a coating, it is water-tight. When expanded in the artery, it stops antegrade flow. Then, as you aspirate through it, you reverse the flow direction. This retrograde flow now aligns with the path a stent retriever-engaged clot must travel to be captured. This feature increases the likelihood of capturing the clot, along with microemboli or fragments, during the recovery phase of a stent retriever mechanical thrombectomy procedure.
The ANAIS study demonstrated promising clinical outcomes—can you elaborate on key data points that supported CE Mark approval and what they reveal about first-pass success and reperfusion rates?
The data highlighted the funnel catheter’s ability to achieving first-pass effect (FPE). As a feasibility study, ANAIS allowed us to explore how funnel deployment had a meaningful impact on efficacy. When analyzing the full study cohort, which included varying funnel deployment locations within the internal carotid artery (ICA) and cases that might not have followed the clinical protocol, the overall FPE rates (eTICI 2c-3) were slightly higher than those reported in the literature, at approximately 44% or higher at 51% if we lower the threshold and evaluate FPE as (eTICI2b-50). However, when the funnel was deployed in the C2/C3 segments of the ICA and we ensured that aspiration was correctly applied, the FPE rate increased to 89% in the ITT population and to 100% in the PP population. Interestingly, deploying the funnel even further at higher segments (e.g., C4, ICA) did notyield additional gains, and FPE rates were slightly lower than those observed at C2/C3. For CE marking, First-pass effect is particularly meaningful because fewer device passes translate to a lower risk of vessel injury and potential harm to the patient. For ANAIS, it was very important to demonstrate that no severe device-related adverse events or symptomatic intracranial hemorrhages were observed at 24 hours post-procedure,underscoring the strong safety profile of the device.
In what ways does the ANA5 system address common challenges faced by interventional neurologists during mechanical thrombectomy procedures, especially in complex stroke cases?
Stroke interventions are inherently stressful, as time to reperfusion is critical. The ANA5 device is designed to support these high-pressure procedures with a user-friendly, intuitive flow-mechanics and excellent fluoroscopic visibility. When used according to instructions, it has the potential to improve procedural efficiency and reduce the number of mechanical thrombectomy passes, potentially to just one.
Its compatibility with standard stent retrievers and ability to naturally conform to the vessel wall make it a valuable tool.
With CE Mark approval secured, what are ANACONDA Biomed’s near-term plans for clinical deployment and physician training across stroke centers in Europe?
While the CE Mark expands the population of patients eligible for treatment with
Anaconda’s ANA technology, its initial use will be limited to post-market physician-
initiated studies at sites also participating in the company’s global randomized controlled trial, ATHENA. The company’s short-term goal remains to demonstrate efficacy under this IDE, to support a future submission for FDA labeling approval and market access in the United States.
How does the ongoing ATHENA trial aim to further validate the ANA5 catheter’s clinical performance, and what role will this data play in future regulatory submissions, including in the U.S.?
ATHENA is a global pivotal randomized controlled trial, approved by the FDA, designed to demonstrate the safety and efficacy of the ANA5 catheter. The trial aims to generate robust clinical evidence to support regulatory approval in the United States, allowing physicians access to this innovative “funneling” technology. Upon successful approval of the ANA5 device, Anaconda plans to expand its funnel technology portfolio based on the validated performance of this initial platform.
Chaitrali Gajendragadkar
chaitrali.gajendragadkar@mmactiv.com
Senior Officer - Media Integrations
MedTech Spectrum
www.medtechspectrum.com
