Enrolling 125 participants, a prospective first-in-human SOLONDA study (NCT04095767) will assess safety and efficacy of a new thrombectomy system (Advanced Thrombectomy System; Anaconda Biomed, Barcelona, Spain). Efficacy will be measured by reperfusion achieved, using the modified treatment in cerebral infarction (mTICI) score The thrombectomy system consists of a delivery catheter, a funnel-shaped aspiration catheter, and a stent retriever. When deployed, the funnel self-expands and conforms to the artery diameter up to 5mm. The system is designed to locally arrest flow and allow full thrombus extraction without fragmentation.
The ongoing study aims to the validate previous testing that achieved statistically significant improvement in revascularization rates. Study data will be used to support a regulatory submission to the Food and Drug Administration (FDA).
“We are hoping this study will clinically replicate in vitro testing that has shown our system enables a quick, effective yet safe endovascular treatment for patients suffering from a major ischemic stroke,” explained Francois Salmon, CEO, Anaconda Biomed. “Our mission is to minimize the risk of death and disability following a stroke, and we look forward to using the study results to move us closer to bringing this new alternative to patients.”
“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,” said Alejandro Tomasello, MD head of Neurointerventional department, Vall d’Hebron University Hospital. “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.”