Oli Johnson speaks to Dr. Adnan Siddiqui about Anaconda Biomed’s ANA Funnel Catheter, its enrolment in the ATHENA study and IDE approval.
Dr. Adnan Siddiqui - LinkedIn
Dr. Adnan Siddiqui, coordinate investigator of the ATHENA study
Anaconda Biomed, a medical technology company developing ‘next-generation’ thrombectomy systems, announced in summer 2024 that it had received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin the ATHENA study of its ANA5 Advanced Neurovascular Access (ANA) Funnel Catheter. The study will assess the safety and effectiveness of mechanical thrombectomy using the ANA Funnel Catheter in combination with a stent retriever. The ANA Funnel Catheter is designed to assist in neurovascular procedures by facilitating the delivery of other intravascular devices such as stent retriever devices and catheters. The device consists of a radiopaque Nitinol braid covered with a silicone coating to enable local flow arrest.
The company says that studies have shown that flow arrest during mechanical thrombectomy can improve revascularisation rates and clinical outcomes at three months, but the approach has been underutilised to date due to the limitations of current devices. The company says its ANA Funnel Catheter is uniquely designed to facilitate flow arrest during clot retrieval.
Speaking to MTI about the limitations of previous devices, coordinate investigator of the ATHENA study Dr. Adnan Siddiqui, Professor of Neurosurgery and Radiology at UBNS, Director Canon Stroke & Vascular Research Centre, SUNY University at Buffalo, and CEO & CMO of the Jacobs Institute said: “There are two aspects to that. The first aspect is that there is really good data to suggest that flow reversal during mechanical thrombectomy is useful, and that has been the biggest reason why we have a plethora of balloon guide systems in the marketplace. Even though we don’t have randomised data, and that’s not for lack of trying, the NIH has not funded those proposed trials. There have been lots of proposals, but when you look at the overwhelming majority of real-world data, there’s a stark difference in the effectiveness with a balloon guide rather than without. So there’s a strong understanding that I think it makes a big difference.
"I think there’s great clarity that comes with the IDE approval for the company, knowing that if you do this and you hit these metrics, your device will likely be approved.
“Now the second thing that has happened in this space is that people are going with larger and larger and larger catheters inside the brain, but then you don’t have flow reversal in the neck. But when you put this garden hose in the middle cerebral artery, you essentially have flow reversal in the MCA, which is where you want it. That is being investigated in clinical trials right now, and we have had some presented recently, which looks very, very promising. But the issue is, driving a garden hose into the brain still remains a challenge. So the idea of Anaconda is, can you put in a smaller catheter, that has a funnel tip, which can expand to whatever diameter the vessel is, gentler on the vessel than say a traditional large catheter, but equally effective, because the vacuum power of a clot is based on the cross sectional area that interacts with the clot. So the larger the cross-sectional area, the greater the effectiveness of the vacuum to suck it out. Anaconda’s premise is, you don’t need a garden hose, you can go with a smaller catheter, and it’ll work just as well.”
Read more: Anaconda Biomed receives IDE approval for enrollment in ATHENA study
The IDE approval allows for a company, whether it is based in the U.S. or outside of the U.S., to initiate a clinical trial under the aegis of the FDA, a necessary step for medical devices. The approval means that the FDA has looked at the device, the background data, and considered it safe enough to be assessed in a rigorous clinical trial in the United States. It also means that the company has presented, and the FDA has agreed upon the specific markers of what would be considered a successful clinical trial. This is so there is complete alignment in terms of how many patients, what will be the control arm, as well as what are the safety endpoints, effectiveness endpoints and revascularisation endpoints.
Dr. Siddiqui said to MTI: “I think there’s great clarity that comes with the IDE approval for the company, knowing that if you do this and you hit these metrics, your device will likely be approved. Now, the FDA always puts in some language in there as a disclaimer that they reserve the right to not approve even if you meet those things, based on new findings or this that or the other. So they have that caveat, but they typically do not exercise that. So I think it’s a significant step forward for the company.”
"This is vindication that their device is considered reasonably safe and effective for actual trial on patients in the United States.
Upon Institutional Review Board (IRB) approval the ATHENA study of the ANA Funnel Catheter will be conducted at up to 40 U.S. and international centres, enrolling patients experiencing acute ischemic stroke and treated within 24 hours of symptom onset. The study will report acute reperfusion success after a single thrombectomy pass with three of the most commonly used stent retrievers, and on procedural safety between study arms.
Dr. Siddiqui spoke about how having the right kind of regulatory advice can significantly reduce the ‘headache and the heartburn’ and the delays that can be associated with a misguided or uninformed adventure. The doctor says that having the right kind of regulatory advice behind you can be a critical part of a successful passage of a process through the FDA.
Dr. Siddiqui told MTI: “There are people who have been doing this for their entire lives, rely on them to guide you, make sure you pick the right regulatory partners to be able to lead things forward. As far as the company is concerned, I think this is a tremendous milestone for them, because this is vindication that their device is considered reasonably safe and effective for actual trial on patients in the United States.”
Dr. Siddiqui concluded: “What still remains up in the air is exactly what the results are going to be in this rigorous trial. And we’ll certainly wait to find that part out, but I think this is a successful combination of a rigorous regulatory process, and congratulations to the company.”
