No VTE/DVT Study Published to Date Has Had an Initial Goal of Demonstrating Efficacy in a Single Session Setting, Without the Crutch of Post-Procedural Lytic Infusion
A groundbreaking VTE study was presented by Dr. Jean Cournoyer-Rodrigue, MD (CHUM Research Center, Montreal, Canada), during The Cardiovascular and Interventional Radiology Society of Europe’s Annual Meeting (CIRSE 2018). The news was announced by Walk Vascular, LLC.
The study: Assessment of the safety and efficacy of the JETI-8 Peripheral Thrombectomy System for the treatment of acute deep vein thrombosis is significant for both its treatment intent and impressive results.
David Look, President of Walk Vascular told Medical Device News Magazine, “To our knowledge, no venous thromboembolism (VTE) or deep venous thrombosis (DVT) study published to date has had an initial goal of demonstrating efficacy in a single session setting, without the crutch of post-procedural lytic infusion (CDT).” He added, “It is well understood that avoidance of ICU lytic surveillance would be not just significant in its cost reduction, but most importantly for reducing exposure of patients to unnecessary risk. This was the clarity offered by the ATTRACT trial. If somehow lytic, or bleed risk could be eliminated from the intervention equation, then VTE intervention calculus changes.”
The company reports that Jeti was tested in 23 VTE procedures, resulting in 83% technical success — restoration of antegrade flow with the elimination of any obstructing lesion, without overnight CDT. In addition, 4/23 procedures required post procedure lytic infusion before achieving procedural and technical success, with overnight CDT. Relative to current thrombectomy market leaders, i.e. Angiojet, who have only demonstrated single session success 34% in their seminal Pearl registry, this is a quantum leap in performance. No complication, hemolysis, or blood transfusion was reported. Mean thrombus removal across all patients was 93%. “David Look concluded, “Overall JETi’s new technology has shown great promise and has become a welcome addition to the tools interventionists require to face one their most daunting clinical challenges.”
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