Sutra TMVR delivery system development and V&V testing

项目总结 二尖瓣返流(MR)是美国最常见的心脏瓣膜病。 美国有410万中重度MR患者需要治疗。然而，只有 由于担忧，美国每年约有5万名患者接受MR手术 关于程序的复杂性和病人的安全。在心脏瓣膜中有很大的热情 业界和临床医生将开发经导管二尖瓣修复术(TMVRep)和置换 (TMVR)，为MR患者提供侵入性较小的治疗选择。经过十多年的 在开发过程中，只有一种设备MitraClip获得了FDA的批准，并正在商业化 可用。虽然MitraClip是安全的，具有已证实的临床益处，但在消除MR方面并不有效 在所有患者中，即使是轻微的MR也会增加发病率和死亡率。TMVRep 而正在开发中的TMVR设备只对精心挑选的患者安全有效。 在这份提案中，杜拉生物科技公司提出开发新型佛经半瓣式TMVR 该系统结合了外科MV置换、TMVR和TMVRep的最佳方面 为植入的经半瓣膜先生提供优雅而有效的解决方案的方法 TMVR系统用一种新型的三叶人工瓣膜取代天然的二尖瓣后叶 在设计和功能上模仿天然的二尖瓣后叶，以提供可预测和 一致的MR减影。因为经半瓣TMVR系统只覆盖后部 MV的一部分，它消除了常见的左心室流出道梗阻 替换设备，并实现更小的设备配置文件，以实现安全的跨间隔访问和 送货。通过实验验证了经半阀TMVR的可行性 严格的实验台和临床前动物试验。 此CRP项目的目标是最终确定后期开发和 新型佛经半阀TMVR系统的商业化。为了实现这一目标，在目标1 在这个项目中，佛经递送系统将通过GLP体内动物实验进行优化。在……里面 目标2，将对最终的Sutra系统设计进行验证和确认测试，并 将根据数据向FDA提交早期可行性研究(EFS)申请。 这个CRP项目的成功完成将帮助杜拉跨越 开发和商业化有助于将佛经半阀TMVR系统推向市场 并为数百万患有MR的患者提供几乎没有治疗选择的服务。

PROJECT SUMMARY Mitral regurgitation (MR) is the most prevalent valvular heart disease in the U.S. There are 4.1 million patients in the US with moderate to severe MR requiring treatment. However, only approximately 50,000 patients in the U.S. undergo surgery for MR each year due to concerns about procedural complexity and patient safety. There is great enthusiasm among the heart valve industry and clinicians to develop transcatheter mitral valve repair (TMVRep) and replacement (TMVR), offering less invasive treatment options for MR patients. After more than a decade of development, only one device, the MitraClip, has been approved by the FDA and is commercially available. While safe with proven clinical benefits, the MitraClip is not effective in eliminating MR in all patients, and even mild MR is associated with increased morbidity and mortality. TMVRep and TMVR devices in development are only safe and effective for carefully selected patients. In this proposal, Dura Biotech proposes to develop the novel Sutra Hemi-valve TMVR system which combines the best aspects of surgical MV replacement, TMVR, and TMVRep approaches to pose an elegant and effective solution for MR. The implanted Sutra Hemi-valve TMVR system replaces the native posterior mitral leaflet with a novel tri-leaflet prosthetic valve that mimics the native posterior mitral leaflet in design and function, to provide predictable and consistent MR reduction. Because the Sutra Hemi-valve TMVR system only covers the posterior portion of the MV, it eliminates left ventricular outflow tract obstruction seen commonly with other replacement devices, and enables a smaller device profile for safe, trans-septal access and delivery. The feasibility of the Sutra Hemi-valve TMVR system has been demonstrated through rigorous bench and preclinical animal testing. The goal of this CRP project is to finalize the late stage development and commercialization of the novel Sutra Hemi-valve TMVR system. To achieve this goal, in aim 1 of this project, the Sutra delivery system will be optimized through GLP in vivo animal studies. In aim 2, verification-and-validation tests will be performed on the final Sutra system design, and the data will be complied for submission of an Early Feasibility Study (EFS) application to the FDA. Successful completion of this CRP project will help Dura cross the “valley of death” between development and commercialization to help bring the Sutra Hemi-valve TMVR system to market and serve millions of patients suffering from MR with little-to-no treatment options.