Percutaneous venous valve bioprosthesis: initial observations

Chronic deep venous insufficiency remains a major health problem in the United States and worldwide. Selected patients benefit from direct deep vein valve repair or valve transplantation; however, most are not candidates for these procedures. Experience with the bovine monocusp venous valve surgically inserted into the common femoral vein (CFV) demonstrates potential benefit and good long-term patency. A venous valve placed distal to the CFV via percutaneous access has great appeal and potential for further improving venous hemodynamics, as well as reducing ambulatory venous hypertension and ulceration. Two patients were treated with a percutaneous venous valve bioprosthesis as part of a Phase I trial. The primary objective was to evaluate the safety, patency, and efficacy of the percutaneous venous valve bioprosthesis to restore competency to the deep venous system.