Anaconda Biomed Receives IDE Approval to Initiate Enrollment in the ATHENA Study
July 17 2024 - 6:05AM
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
- 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
- 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.
- 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
- Goyal M, Kappelhof M, Ospel JM, et al. Balloon guide catheters:
use, reject, or randomize? Neuroradiology 2021;63(8):1179-83.
- AN10055 / AN10126 / AN09443 Pre-clinical assessment of ANA5
flow arrest
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