Venarum Medical, LLC (Venarum) proposes to verify the pre-clinical safety of the Endoscopic Venous Valve System (EVVS), a novel patent-pending valve-replacement solution for treatment and mitigation of serious complications of chronic venous disease (CVD) such as chronic venous insufficiency (CVI) and related dysfunctional venous valves. This endovascularly delivered device is intended to reduce the risk of edema, ulcers, amputation or other related complications. It is based on the principle that a novel Nitinol stent-like scaffold embedded in a biocompatible, thrombus-resistant polymer with a polymeric (same material as scaffold coating) inner-valve comprised of flexible valve leaflets, placed at/near the site of valve failure will significantly reduce reflux while allowing self-flushing (little/no blood stagnation) and adequate forward flow. CVI and related valve dysfunction is a costly long-term and progressive disease that afflicts approximately 2.5 million Americans per year. Associated venous valve reflux leads to blood clotting and/or fluid leakage into skin and other tissues in the legs and ankles. Resulting health issues are severe and costly to treat. CVI can manifest itself in both superficial and deep veins, but deep veins are the most crucial to circulation. Current clinical solutions treat only the symptoms of CVI but not the underlying physiological causes, so effective treatment of CVI in deep veins is an unmet clinical need. The past few decades have seen dramatic improvements in understanding the causes and course of CVI, and vast progress in the use of Nitinol stents and long dwelling polymer based devices. Armed with ?lessons learned? and a unique design approach, Venarum is developing a prosthetic endovascular venous valve comprising a stent-like Nitinol frame with an integral novel polymer leaflet valve securely attached to its inner structure. The implant operates at similar flow and pressure conditions as in the body with low opening and closing pressure differentials, provides adequate forward flow, minimizes reflux and thrombus formation, and is suitable for percutaneous endovascular delivery. Further, the valve prosthesis is designed for precise deployment, canalization of the vein lumen, migration resistance, and long-term durability post-deployment. Venarum has successfully completed the EVVS feasibility development and with that have completed all tasks proposed for Phase I. Successful Phase I development included: (1) Optimization of the best proof-of-feasibility valve structure and related test methodologies; (2) Bench and characterization function testing of the two best valves; and (3) Completion of acute non-GLP animal studies including proof of ease-of-use and positioning, device stability, proper flow including assessment of forward, flow, stagnation and reflux. For this Phase II proposal, Venarum proposes to (1) perform physical verification testing of final EVVS device; (2) perform bio- and hemo- compatability testing of final EVVS device; and (3) Perform in-vivo chronic animal studies of final EVVS device. All testing will be per the Product Definition and Product Input Specifications developed with the Venarum team of advisors. These documents will be used as a ?road map? during this Phase II but will also be revised as pre-submission meetings with the FDA progress and as ongoing risk assessments require. Concurrent to the proposed Specific Aims, Venarum will be working with its extended team to develop the US clinical protocol for submission to the FDA. With completion of each of these specific aims, Venarum will also prepare an IDE pre-sub for evaluation by the FDA towards US FDA feasibility trial readiness.
A serious complication of chronic venous disease (CVD), Chronic Venous Insufficiency (CVI), and related venous valve dysfunction, is a costly long-term and progressive condition that afflicts 2.5 million Americans. The resulting venous valve reflux in the legs leads to blood clotting or fluid/blood cell leakage into the skin and other tissues causing serious health complications. Venarum?s proposed prosthetic endovascular venous valve system may produce dramatic improvement in the technical and medical understanding of CVD problems, and could enable a treatment option for CVI patients that does not exist today.
