Extrapolation of Data from the Vascular Literature reveals that…
…the present prevalent population demonstrates that 40% of all adult individuals suffer with Chronic Venous Insufficiency and this is one of the most debilitating disease entities, worse than angina and arthritis.
…the incidence of Chronic Deep Vein Insufficiency as a consequence of Deep Vein Thrombosis is approximately 500,000 cases per year; with the incidence of hospitalization for Deep Venous thrombosis at 100,000 patients per year.
…for the U.S, the candidate patient population for the VenoValve® is at present approximately 2.0 million with the potential candidate incidence rate at over half a million annually.
Based on management’s broad experience related to the design, safety and efficacy and clinical commercialization of bioprosthetic cardiac valves, Hancock Jaffe Laboratories has developed a bioprosthetic venous valve, the VenoValve®, to correct or reduce the venous reflux within the deep venous system. The device comprises a biologic valve mounted in a supporting metal frame that will allow for a straightforward surgical insertion of the bioprosthesis into the deep femoral vein.
Preclinical prototype testing, including in vivo animal studies and in vitro hemodynamic studies, have demonstrated that the VenoValve® is remarkably similar to normal venous valve function. Figure 1 shows the movement of the valve in physiologic testing under changes in pressure and cardiac output. Figure 2 demonstrates an ascending and descending venogram in a sheep of an implanted. The descending venogram (figure 2 A) demonstrates patency of the VenoValve® and the ascending venogram (figure 2b) demonstrating function of the valve in preventing venous reflux. Figure 3 demonstrates implantation of the VenoValve® in sheep external jugular vein.
This demonstrates opening and closing of the VenoValve® under low pressure and low cardiac output.
This is an ascending venogram demonstrating patency of the VenoValve®, allowing normally directed blood flow to return to the heard.
This is a descending venogram demonstrating closure of the VenoValve® in preventing reflux or allowing blood to pool in the lower extremity. This demonstrates the normal function of a venous valve.