17 July 2024

Anaconda Biomed Receives IDE Approval to Initiate Enrollment in the ATHENA Study

Anaconda logo - Ysios Capital

BARCELONA, Spain–(BUSINESS WIRE)–Anaconda Biomed S.L., a medical technology company developing next-generation thrombectomy systems, has announced that it has received conditional IDE approval from the U.S. Food and Drug Administration to begin the ATHENA study of its ANA Funnel Catheter. The prospective, randomized, dual-arm, multi-center study will assess the safety and effectiveness of mechanical thrombectomy using the ANA Funnel Catheter in combination with a stent retriever.

“The neurointerventional community is eager to assess this innovative technology, which is designed to enhance the efficiency of mechanical thrombectomy,” said Dr. Adnan Siddiqui, coordinating investigator of the ATHENA study. “Even a small difference in the revascularization success after one pass can have a profound impact on the clinical outcomes of people with ischemic stroke.”

Studies have shown that flow arrest during mechanical thrombectomy can improve revascularization rates and clinical outcomes at three months1,2,3. However, the approach has been underutilized to date due to the limitations of current devices3,4. Anaconda Biomed’s ANA Funnel Catheter is uniquely designed to facilitate flow arrest during clot retrieval5.

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 centers 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.

The IDE approval marks an exciting milestone in our company’s mission to deliver new, safe and effective solutions that can meaningfully improve the treatment of stroke,” said Anaconda Biomed CEO Francois Salmon. “We believe the ANA Funnel Catheter has the potential to transform the treatment of acute ischemic stroke, improving neurological outcomes and benefiting countless patients.

About ANA Funnel Catheter

ANA5 Advanced Neurovascular Access™ (ANA Funnel Catheter) is a funnel catheter designed to assist in neurovascular procedures by facilitating the delivery of other intravascular devices (i.e., stent retriever devices and catheters). The device consists of a radiopaque Nitinol braid covered with a silicone coating to enable local flow arrest. The catheter is currently an investigational device and is not available for sale in the United States or the European Union.

About Anaconda Biomed

Anaconda Biomed is an innovative medical technology company dedicated to developing next-generation thrombectomy systems for the treatment of ischemic stroke. At the heart of its product portfolio is the ANA Funnel Catheter. Anaconda Biomed has received funding from prominent life science investment firms, including Ysios Capital, Omega Funds, Innogest, Asabys Partners, Banco Sabadell, and private investors. Additionally, through public grants, the company has received significant public support from Enisa, CDTI (Neotec), the Ministry of Science & Innovation (Emplea and Retos), EIB, and EIT Health. For more information, please visit https://anaconda.bio and follow the company on LinkedIn.

References

  1. Podlasek, Dhillon , et al. Clinical and Procedural Outcomes with or without Balloon Guide Catheters during Endovascular Thrombectomy in Acute Ischemic Stroke: A Systematic Review and Meta-analysis with First-line Technique Subgroup Analysis. AJNR Am J Neuroradiol2021;42(8):1464-71
  2. Pederson JM, Hardy N, Lyons H, Sheffels E, Touchette JC, Brinjikji W, Kallmes DF, Kallmes KM. Comparison of Balloon Guide Catheters and Standard Guide Catheters for Acute Ischemic Stroke: An Updated Systematic Review and Meta-analysis. World Neurosurg. 2024 May;185:26-44.
  3. Nguyen TN, Malisch T, Castonguay AC. Balloon guide catheter improves revascularization and clinical outcomes with the Solitaire device: analysis of the North American Solitaire Acute Stroke Registry. Stroke 2014;45:141–5
  4. Goyal M, Kappelhof M, Ospel JM, et al. Balloon guide catheters: use, reject, or randomize? Neuroradiology 2021;63(8):1179-83.
  5. AN10055 / AN10126 / AN09443 Pre-clinical assessment of ANA5 flow arrest

Contacts

Joe Duraes
Pazanga Health Communications
jduraes@pazangahealth.com
+1 917-687-6419

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