BARCELONA, Spain--(BUSINESS WIRE)--Initial single-center clinical study data supporting Anaconda Biomed’s Advanced Neurovascular Access™ (ANA) Catheter System for the treatment of ischemic stroke have been published in the Journal of Neuroradiology by investigators at Hospital Vall d’Hebron in Barcelona. The hospital is participating in the multi-center SOLONDA (“SOL”itaire in combination with the ANA Catheter system manufactured by Anac”ONDA”) clinical trial, a 125-patient, prospective study that will assess system safety and reperfusion measured using the modified treatment in cerebral infarction (mTICI) score.
Hospital Vall d’Hebron investigators followed 35 consecutive patients, with published results as follows:
- The primary endpoint, defined as successful reperfusion (mTICI 2b-3) within three passes without rescue therapy, was achieved in 91.4% of patients, with a rate of complete reperfusion (mTICI 2c-3) of 65.7%
- The rate of first-pass complete recanalization (mTICI≥2c) was 42.9%
- The rate of sudden recanalization was 82.9%
- Median number of ANA Catheter System passes was 1
“The ANA device showed promising high rates of first pass complete recanalization,” said Lead Author and Principal Investigator, Dr. Alejandro Tomasello. “We hope that the device completes the regulatory process soon.”
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.
“Vall d’Hebron’s early results are fulfilling our expectations for the safety and efficacy of the ANA System,” said Francois Salmon, CEO of Anaconda Biomed. “Its performance in this study, which was designed with great clinical rigor, is a testament to the system’s potential to benefit physicians and patients.”
About Anaconda Biomed
Anaconda Biomed is a medical technology company dedicated to developing next-generation thrombectomy systems for the treatment of ischemic stroke. Its flagship product is the Advanced Thrombectomy System. 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 Enisa, CDTI (Neotec), Ministry of Science and Innovation (Emplea and Retos), ACCIÓ (Nuclis) and EIT Health public grants. The ANA Catheter System is an investigational device and is not available for sale in the United States or the European Union. For more information, visit https://anaconda.bio/.
