Hancock Jaffe Laboratories has submitted an application to the US FDA to market its ProCol vascular bioprosthesis as a conduit for haemodialysis access. The premarket approval application follows the completion of US multicentre clinical trial that, according to the firm, provided "very encouraging results in an extremely challenging cohort of patients". The bioprosthesis offers patency rates similar to those commonly experienced by patients without a history of multiple prosthetic graft failures, noted the Irvine, California company. The product, which is already available in Europe, is made from a bovine mesenteric vein, which is processed to render it inert and fully biocompatible.
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