EVVS: Endoscopic Venous Valve System

EVVS：内窥镜静脉瓣膜系统

基本信息

批准号：
9622320
负责人：
Janet Galtes
金额：
$ 116.54万
依托单位：
VENARUM MEDICAL, LLC
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-07-01 至 2020-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9622320
关键词：
Activated Partial Thromboplastin Time measurement Acute Affect Aging American Amputation Animals Ankle Benchmarking Biological Blood Blood Cells Blood Circulation Blood coagulation Certification Chronic Clinical Clinical Engineering Clinical Protocols Collection Comorbidity Complement Activation Complication Corrosion Data Deep Vein Thrombosis Development Device Safety Devices Disease Edema Embolism Evaluation Extravasation Failure Family suidae Fatigue Feasibility Studies Femoral vein Finite Element Analysis Flushing Formulation Functional disorder Guidelines Health Hemolysis Iliac Vein Implant In Vitro Individual Leg Legal patent Liquid substance Lung Magnetic Resonance Imaging Maps Medical Medical Device Methodology Methods Miniature Swine Modification Obstruction Pathologic Patients Performance Phase Physiological Polymers Positioning Attribute Process Progressive Disease Prospective Studies Prosthesis Readiness Reflux Resistance Review Literature Risk Risk Assessment Safety Secure Series Site Skin Stents Structure Structure of superficial vein Sudden Death System Testing Thrombus Time Tissues Toxic effect Ulcer Veins Venous Venous Insufficiency Walking Work aged arm base biomaterial compatibility cohort cost cytotoxicity deep vein design effective therapy experience feasibility trial flexibility in vivo irritation meetings migration nitinol novel persistent symptom phase 2 study preclinical safety pressure product development prototype scaffold valve replacement

项目摘要

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 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.

项目概要/摘要 Venarum Medical, LLC（Venarum）提议验证内窥镜静脉瓣膜的临床前安全性系统 (EVVS)，一种正在申请专利的新型瓣膜置换解决方案，用于治疗和缓解严重的慢性静脉疾病（CVD）的并发症，例如慢性静脉功能不全（CVI）及相关这种血管内输送装置旨在降低水肿的风险，它基于一种新型镍钛诺支架样的原理。支架嵌入生物相容性、抗血栓聚合物中，具有聚合物（与支架材料相同）涂层）内瓣膜由柔性瓣膜小叶组成，放置在瓣膜失效部位/附近将显着减少反流，同时允许自冲洗（很少/没有血液停滞）和足够的前向流动。 CVI 和相关的瓣膜功能障碍是一种昂贵的长期进展性疾病，影响约 2.5 每年有数百万美国人因静脉瓣膜反流而导致血液凝固和/或液体渗漏。腿部和脚踝的皮肤和其他组织会出现严重的健康问题，并且治疗费用昂贵。浅静脉和深静脉都有表现，但深静脉对循环最重要。临床解决方案仅治疗 CVI 的症状，而不治疗潜在的生理原因，因此有效深静脉 CVI 的治疗是一个未得到满足的临床需求。人们对 CVI 的原因和病程的了解有所提高，镍钛诺支架的使用取得了巨大进展，基于长聚合物住宅的设备，Venarum 拥有“经验教训”和独特的设计方法。正在开发一种人工血管内静脉瓣膜，该瓣膜包含一个类似支架的镍钛诺框架，该框架具有一体式新型聚合物小叶瓣膜牢固地附着在其内部结构上，并且以相似的流量和速度运行。压力条件如体内具有较低的打开和关闭压差，提供了足够的向前流动，最大限度地减少反流和血栓形成，适合经皮血管内手术此外，瓣膜假体设计用于精确部署、静脉腔疏通、抗迁移性和部署后的长期耐用性。 Venarum 已成功完成 EVVS 可行性开发并完成所有任务提议第一阶段。第一阶段的成功开发包括： (1) 最佳可行性证明的优化 (2) 两个最佳的基准和表征功能测试 (3) 完成急性非 GLP 动物研究，包括易用性和定位证明，装置稳定性、适当的流动，包括评估前进、流动、停滞和回流。对于第二阶段提案，Venarum 建议 (1) 对最终 EVVS 设备进行物理验证测试； (2) 对最终 EVVS 装置进行生物和血液相容性测试；以及 (3) 进行体内慢性动物测试；最终 EVVS 设备的研究将按照产品定义和产品输入规范进行。与 Venarum 顾问团队一起开发的这些文件将在此期间用作“路线图”。第二阶段，但也将被修订为 FDA 进展的提交前会议以及持续的风险在实施拟议的具体目标的同时，Venarum 将与其扩展一起工作。团队制定美国临床方案并提交给 FDA。 Venarum 还将准备一个 IDE pre-sub 供 FDA 评估，以进行美国 FDA 可行性试验准备状态。