November 4, 2019
First-in-Human Study Evaluates Anaconda Biomed's Next-Generation Stroke Thrombectomy System
November 5, 2019—Anaconda Biomed, a company developing a next-generation thrombectomy system for the treatment of ischemic stroke, announced the completion of initial patient cases in a first-in-human study at Hospital Vall d’Hebron in Barcelona, Spain. Marc Ribo, MD, performed the study’s first case.
Anaconda stated that the prospective, multicenter study will be composed of 125 patients to assess system safety and reperfusion measured using the modified treatment in cerebral infarction (mTICI) score. The ongoing, in-human study aims to validate earlier testing that achieved statistically significant improvement in revascularization rates at both first and third pass. Study data will be used to support a regulatory submission to the FDA.
According to the company, the thrombectomy system consists of a delivery catheter, a funnel-shaped aspiration catheter, and a stent retriever. When deployed, the funnel self-expands and directly conforms to the artery diameter up to 5 mm. It is designed to locally arrest flow and allow full thrombus extraction without fragmentation. The company’s thrombectomy system is an investigational device and is not available for sale in the United States or the European Union.
Alejandro Tomasello, MD, Head of the Neurointerventional Department at Vall d’Hebron, serves as Principal Investigator of the study.
“With the first study participants completed, we are beginning to gather results that will enable us to establish an mTICI score for Anaconda’s thrombectomy system,” commented Dr. Tomasello in the company’s announcement. “This study is looking at how effective this system is in overcoming the limitations of other approaches. Typically, difficulties with distal blood flow arrest and clot fragmentation to no or low reperfusion at first pass have limited the success of other systems. As this study expands to additional centers and additional patients, we anticipate a robust and conclusive set of data.”