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EndoShunt has developed fully functional manufactured prototypes of its length-adjustable endovascular shunt, with proven efficacy in benchtop and simulated traumatic vascular injury studies. The company is preparing for FDA 510(k) clearance and plans pilot launches at trauma centers following regulatory approval. No human clinical trial results have been published yet, but preclinical data support the product’s effectiveness at controlling hemorrhage while maintaining distal perfusion during trauma surgery[2][3][5].
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