Research Project
9408948
Project Summary / Abstract Venarum Medical, LLC (Venarum), proposes to validate the ?Endoscopic Venous Valve System? (EVVS), a novel patent-pending valve-replacement solution for serious complications of chronic venous disease (CVD) such as chronic venous insufficiency (CVI) and specifically, dysfunctional venous valves. This device is based on the principle that a nitinol stent-like scaffold embedded in a biocompatible, thrombus-resistant polymer with a similar polymeric inner-valve comprised of flexible valve leaflets, placed at the site of valve failure (i.e. dysfunctional valve) will provide improved forward flow, and reduce risk of edema, ulcers, and amputation. Chronic venous insufficiency (CVI), often caused by venous 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 polymer valves. Armed with ?lessons learned? and a unique design approach, Venarum will develop an endovascular prosthetic venous valve comprising a stent-like Nitinol frame with an integral novel polymer leaflet valve securely attached to its inner structure. Venarum expects to create a valve that operates 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 will be designed for precise deployment, canalization of the vein lumen, and non- migration post-deployment. Venarum will employ a proven Nitinol prosthesis design team using detailed performance requirements to develop the proposed valve system design. An advanced prototype frame and valve will be developed using an iterative approach which refines candidate designs using 2D & 3D modeling, numerical strain analysis, rapid prototyping and precision in vitro testing. Resulting prototypes will then be evaluated and refined for fluid flow performance, endoscopic delivery, and durability. Bench test evaluations including those for radial strength, crimping, forward flow, leak/reflux, flow stagnation, burst pressure, tear resistance, and fatigue will be conducted. Hemocompatibility, related in vitro tests, and an in vivo acute animal study will be the culmination of Phase I. Venarum?s proposed prosthetic venous valve could greatly alleviate complications related to CVI, produce dramatic improvement in the technical and medical understanding of CVI problems, and may one day enable an affordable treatment option for CVI that does not exist today.
