Research Project
9935592
Project Summary / Abstract 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 proposes the mentorship of an individual from a statistically underrepresented group in most bio- medical-relevant disciplines and in the corporate business environment. This candidate will develop strong and versatile engineering technical skills will cultivating appreciation, interest, and knowledge of aspects required to run a successful medical device business. 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. During Phase II of the EVVS, much of the test method development and final testing must be determined and executed. During this period, Venarum will also be submitting additional patent applications and the next phase of funding. The mentorship candidate has demonstrated both strong technical and writing abilities. As such, it is Venarum?s intention to involve the candidate in the business aspects as well as the engineering assignments necessary to the development of the EVVS.
