BARCELONA, Spain--(BUSINESS WIRE)--Multi-center clinical study data supporting Anaconda Biomed’s ANA Advanced Neurovascular Access™ (ANA) Catheter System for treating ischemic stroke has been published in the journal Stroke. The SOLONDA (“SOL”itaire in combination with the ANA Catheter system manufactured by Anac“ONDA”) clinical trial is a 125-patient, prospective study designed to assess system safety and reperfusion measured using the modified treatment in cerebral infarction (mTICI) score.
The Steering Committee decided to terminate the study after enrollment of 74 patients, when an interim analysis found overwhelming evidence confirming that safety and performance objectives were already met.
The published results are as follows:
- The primary endpoint, defined as successful reperfusion (mTICI 2b-3) within three passes before rescue therapy, was achieved in 83.3% of patients, with a rate of complete reperfusion (mTICI 2c-3) of 60%
- The ANA System showed superiority in the primary outcome analysis (p=0.02) after non-inferiority was confirmed (p<0.01).
- The rates of first-pass successful recanalization (mTICI≥2b) were 56%, with a first pass complete recanalization rate of 39%.
- The rate of favorable functional outcomes (mRS 0-2) at 90 days were 57.5%, with the 90-day rate of excellent functional outcome (mRS-02) at 45.2%
“The ANA System represents an exciting new treatment option in ischemic stroke, where time is brain,” said Lead Author and Principal Investigator, Dr. Alejandro Tomasello, Hospital Vall d’Hebron in Barcelona. “Achieving the highest degree of reperfusion with the minimum attempts, ideally in a single pass, has been described as a robust predictor of favorable outcome. The ANA System performed very well in this regard.”
Anaconda’s investigational ANA Catheter System consists of unique, funnel-shaped delivery and aspiration catheters to be used in combination with a stent retriever. When deployed, the funnel self-expands and directly conforms to the artery diameter up to 5mm. It is designed to locally restrict flow and allow full thrombus extraction without fragmentation. The SOLONDA study aims to validate earlier testing that achieved statistically significant improvement in revascularization rates at both first and third pass.
“The SOLONDA multi-center study results are excellent and consistent with early single-center findings that were published in the Journal of Neuroradiology in December 2020,” said Francois Salmon, CEO of Anaconda Biomed. “We look forward to the opportunity to bring the ANA System to the many physicians and patients affected by ischemic stroke.”
About Anaconda Biomed
Anaconda Biomed is a medical technology start-up company working closely with Vall d’Hebron that is dedicated to developing next-generation thrombectomy systems for the treatment of ischemic stroke. Its flagship product is the ANA Advanced Neurovascular Access™. Anaconda Biomed has received funding from leading life science investment firms Ysios Capital, Omega Funds, Innogest, and Asabys Partners, as well as Banco Sabadell and private investors. The company has also received public support from EIB, Enisa, CDTI (Neotec), Ministry of Science and Innovation (Emplea and Retos), ACCIÓ (Nuclis) and EIT Health public grants. The ANA Catheter System is not available for sale in the United States. For more information, visit https://anaconda.bio/.
