The ongoing clinical study is intended to validate the earlier testing that showed significant improvement in revascularisation rates at both first and third pass
Image: Thrombectomy System is used in treatment of ischemic stroke. Photo: Courtesy of Anaconda Biomed.
Spanish medical technology firm Anaconda Biomed has completed the initial patient cases in the first human trial of its thrombectomy system for the treatment of ischemic stroke, at Hospital Vall d’Hebron in Barcelona, Spain.
The prospective, multi-centre clinical study, involving 125 patients has been designed to evaluate the system safety and reperfusion, measured by the modified treatment in cerebral infarction (mTICI) score.
Vall d’Hebron neurointerventional department head and principal investigator of the study Alejandro Tomasello said: “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. 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.”
Features of Anaconda Biomed’s advanced Thrombectomy System
The company has designed the advanced Thrombectomy System featuring a delivery catheter, funnel-shaped aspiration catheter, and a stent retriever.
When the system is deployed, the funnel expands itself and directly adapts to the artery diameter up to 5mm, to locally seize the flow and facilitate thrombus extraction completely without any fragmentation.
The ongoing clinical study is intended to validate the earlier testing that showed significant improvement in revascularization rates at both first and third pass. The company plans to use the study data for regulatory submission to the US FDA.
Anaconda Biomed CEO Francois Salmon said: “This first-in-human study is an important step forward for Anaconda Biomed as we look to demonstrate the efficacy of our Advanced Thrombectomy System. 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.
“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.”