The discussion and conclusions presented in this document are based on the results of preclinical studies and are not intended to represent any approved or commercially available device(s).

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Venous Valve — The VenoValve®

Lower Limb Chronic Deep Vein Insufficiency is a debilitating disease presently affecting millions of patients in the United States with approximately two million new cases worldwide annually. The hallmark of the disease is the failure of damaged venous valves to allow for lower limb venous blood to return to the heart. The resulting “backward flow” or reflux gives rise to pain, itching, severe and uncontrollable swelling which results in reduced mobility and severe prolonged skin ulcerations.

Presently, no medical or nonsurgical treatment other than compression “garments” are available for the care of these patients. Surgical procedures intended to repair, transplant or peel off venous tissue to create new valves are extremely complex with few centers performing these world wide. The refractory nature of deep vein disease treatment continues to be of major concern with the re-establishment of normal venous flow, reduction of reflux as the only considered remedy.

Chronic Deep Vein Insufficiency is primarily associated with three disparate etiologies: congenitally weak valves and/or vein walls, high venous pressure commonly referred to as venous hypertension and deep vein thrombosis.

Significant risk factors that predispose individuals to Chronic Deep Vein Insufficiency onset and progression include:

  • A history of deep vein thrombosis
  • A sedentary lifestyle
  • Standing for extended periods of time
  • Work related activity compromising lower limb position or bearing
  • Age
  • Obesity
  • Smoking

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.

Figure 1

This demonstrates opening and closing of the VenoValve® under low pressure and low cardiac output.

Figure 2A

This is an ascending venogram demonstrating patency of the VenoValve®, allowing normally directed blood flow to return to the heard.

Figure 2B

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.

Figure 1

Figure 3

Potential Benefits of the VenoValve®

…provide for a paradigm shift in the treatment of Lower Limb Chronic Deep Vein Insufficiency; improving venous reflux;

…provide a durable solution for the 10-35% of adults with lower limb deep vein dysfunction, reducing the 4-6 million workdays and billions of dollars lost annually to lower limb Chronic Deep Vein Insufficiency;

…placement of theVenoValve® may be determined with a standardized Doppler examination and subsequent to implant Doppler examination can confirm valve function;

…in contrast to complex surgical approaches the VenoValve® can be introduced using standard vascular surgery techniques, making it accessible to more patients;

…procedure may be performed under local or regional anesthesia.