Interview Insights: Anaconda Biomed’s ANA Funnel Catheter and ATHENA Study

Overview of Anaconda Biomed

Oli Johnson speaks to Dr. Adnan Siddiqui about Anaconda Biomed’s revolutionary ANA Funnel Catheter, its enrolment in the pivotal ATHENA study, and the crucial Investigational Device Exemption (IDE) approval process.

The Significance of IDE Approval

Anaconda Biomed, a prominent player in the medical technology sector focused on advancing thrombectomy systems, announced a significant milestone in summer 2024: the company secured conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate the ATHENA study for its pioneering ANA5 Advanced Neurovascular Access (ANA) Funnel Catheter. This innovative study aims to meticulously evaluate the safety and efficacy of employing mechanical thrombectomy techniques with the ANA Funnel Catheter, particularly when used in conjunction with a stent retriever.

Design and Purpose of the ANA Funnel Catheter

The ANA Funnel Catheter is ingeniously engineered to streamline neurovascular procedures. Its primary function is to aid in the effective delivery of various intravascular devices, including stent retrievers and catheters. Built with a radiopaque Nitinol braid encased in a silicone coating, the device is designed to facilitate local flow arrest—an essential feature in successful thrombectomy procedures.

Anaconda Biomed has presented compelling studies that suggest implementing flow arrest during mechanical thrombectomy significantly enhances revascularization rates and clinical outcomes at the three-month mark. However, this technique remains underutilized due to the constraints posed by existing devices. The company’s innovative ANA Funnel Catheter is uniquely crafted to address these limitations, thereby optimizing flow arrest during the critical process of clot retrieval.

Expert Insights from Dr. Adnan Siddiqui

In a discussion with MTI, Dr. Adnan Siddiqui, a key figure and coordinate investigator of the ATHENA study, who holds esteemed positions as a Professor of Neurosurgery and Radiology at UBNS, and Director at the Canon Stroke & Vascular Research Centre within SUNY University at Buffalo, as well as CEO & CMO of the Jacobs Institute, emphasized the legacy of traditional devices. He noted, “There are two significant aspects to the limitations we face. Firstly, robust data indicates that employing flow reversal during mechanical thrombectomy is highly beneficial. This understanding has led to a saturation of balloon guide systems available in the market today. Despite the absence of randomized data—largely due to a lack of funding from institutes like the NIH—real-world data consistently demonstrates marked differences in effectiveness when these systems are utilized, highlighting their crucial role in patient outcomes.”

“The clarity provided by the IDE approval is critical for our operations, indicating that if we execute this project effectively, there is a high probability of device approval.”}

Dr. Siddiqui further elaborates on the ongoing trend towards the utilization of increasingly larger catheters in neurovascular procedures. He articulated, “As catheter size increases, particularly in the brain’s vasculature, it poses new challenges, especially regarding flow reversal in the neck region. The challenge remains to effectively drive a large vessel into areas like the mid-cerebral artery. Nonetheless, this is the focus of current clinical investigations, with promising results emerging recently. Anaconda’s approach seeks to revolutionize this practice by introducing a smaller catheter equipped with a funnel tip. This design can expand variably to accommodate the diameter of the vessel involved, providing a gentler interaction with the vasculature compared to traditional large catheters while maintaining the vacuum efficacy necessary for effective clot removal.”

The Role of IDE Approval in Clinical Trials

The IDE approval granted to Anaconda Biomed signifies an important regulatory achievement. It allows companies—whether they are based in the United States or abroad—to undertake clinical trials under FDA oversight, a critical step in the development of medical devices. The approval process indicates that the FDA has reviewed the device, the supporting data, and deemed it safe for trial in a controlled clinical setting. Furthermore, the company and the FDA have established clear parameters for what constitutes a successful clinical trial, including the number of participants, details of the control arm, safety endpoints, effectiveness measures, and revascularization goals.

Dr. Siddiqui remarked on the significance of the IDE approval for the company, noting, “The clarity provided by this approval is a tremendous asset. It indicates that if we achieve our designated metrics, the likelihood of our device receiving final approval is high. While the FDA retains the option to deny approval based on new findings, this is rarely exercised, marking a major stride forward for Anaconda Biomed.”

“This milestone serves as a validation that their device is now regarded as reasonably safe and effective, warranting progression to trials involving human patients in the United States.”

Partnerships, Trials, and Regulatory Guidance

Following Institutional Review Board (IRB) approval, the ATHENA study will be conducted across up to 40 clinical centers both in the U.S. and internationally. This study plans to enroll patients experiencing acute ischemic strokes who are treated within a critical window of 24 hours from the onset of symptoms. The outcomes will focus on assessing acute reperfusion success after a single pass thrombectomy operation utilizing the three leading stent retriever systems, in addition to evaluating procedural safety across various study arms.

Guidance for Navigating Regulatory Processes

Dr. Siddiqui also stressed the importance of obtaining appropriate regulatory advice, stating that it can significantly alleviate the “headache and heartburn” associated with navigating the complex landscape of regulatory compliance. Engaging the right regulatory partners can be a vital component in ensuring the smooth passage of the approval process through the FDA.

He advised, “Collaborate with experienced professionals who can guide you through the intricate web of regulations to help you make informed decisions. For the company, this IDE approval represents a monumental achievement and validates that their device has been acknowledged for its safety and efficacy potential in clinical trials within the United States.”

Future Prospects and Conclusions

Dr. Siddiqui encapsulated the essence of the ongoing developments by stating, “Although the results from this detailed trial remain uncertain, the anticipation surrounding what’s to come is palpable. This venture epitomizes a successful collaboration between rigorous regulatory practices and innovative medical technology. Congratulations to Anaconda Biomed for reaching such an important milestone!”

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