SBIR Phase I: Novel Self-Closing, Transcatheter, Edge-to-Edge Repair Device to Percutaneously Treat Tricuspid Valve Regurgitation Using Jugular or Femoral Vein Access

SBIR 第一阶段：新型自闭合、经导管、边对边修复装置，利用颈静脉或股静脉通路经皮治疗三尖瓣反流

• 批准号: 2322197
• 负责人: Raghuveer Basude
• 金额: $ 27.5万
• 依托单位: MEDFREE, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2024
• 资助国家: 美国
• 起止时间: 2024-01-15 至 2024-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2322197&HistoricalAwards=false
• 关键词: SBIR; Phase; Novel; Self; Closing

This Small Business Innovation Research (SBIR) Phase I project develops a novel medical device enabling minimally invasive surgical revision and repair of the tricuspid valve. More than 1.6 million patients in the U.S. suffer from moderate to severe tricuspid valve regurgitation (TR) resulting in a market-size exceeding $2.4 billion by 2028. The prevalence of this repair increases with age, with women over 4 times more likely to be affected with TR than men. There are no Food and Drug Administration (FDA)-approved percutaneous devices for TR treatment. Isolated TR surgery is rarely performed due to the inherent risks associated with major surgery with post-operative complications resulting in high morbidity and mortality rates of 36.1% among severe TR patients. Hence, only about 8,000 of all U.S. patients with moderate to severe TR currently receive surgical treatment. This Small Business Innovation Research (SBIR) Phase I project develops a novel, percutaneous, catheter-based device and procedure for surgically revising the tricuspid Valve in patients suffering from Tricuspid Regurgitation (TR). The tricuspid valve is the largest of the four heart valves presenting unique challenges due to its complex anatomy including 3 thin leaflets and location. The valve is difficult to access using traditional femoral vein access. This project aims to provide a novel, low-profile catheter and implant device via the jugular vein. The Phase I objectives include demonstrating the ability to grasp valve leaflets, validating the design using a benchtop model simulating human conditions, further designing, developing and validating an animal model, and performing a transcatheter tricuspid edge-to-edge repair (t-TEER) procedure via the jugular vein in a lab setting. The results from the technology development, bench testing. and preclinical models will further the system towards eventual human use.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这项小型企业创新研究（SBIR）I阶段项目开发了一种新型的医疗设备，实现了三尖瓣的微创手术修订和修复。在美国，超过160万名患者患有中度到重度三尖瓣反流（TR），到2028年，市场规模超过24亿美元。随着年龄的增长，这种维修的患病率增加，女性受TR的影响超过4倍。没有食品药物管理局（FDA）批准的经皮设备用于TR处理。由于严重的TR患者的高发病率和死亡率高36.1％，因此很少进行分离的TR手术，因此很少进行大手术的固有风险。因此，目前有大约8,000名中度至重度TR的美国患者中只有8,000名接受外科手术治疗。 这项小型企业创新研究（SBIR）I阶段项目开发了一种新型，经皮，基于导管的设备和手术，以通过手术修改患有三尖瓣反流（TR）患者的三尖瓣。三尖瓣是四个心脏瓣膜中最大的，由于其复杂的解剖结构包括3个薄片和位置，因此提出了独特的挑战。使用传统的股静脉进入很难进入阀门。该项目旨在通过颈静脉提供一种新型的低调导管和植入设备。 I期目标包括证明能够掌握阀门传单的能力，使用模拟人类条件的台式模型验证设计，进一步的设计，开发和验证动物模型，并在实验室设置中通过Jugular静脉执行经Tricuspid Tricuspid Tricpid Edge-Edge-Edge-Edge-Edge-Edge Repair（T-TEER）程序。技术开发，台式测试的结果。临床前模型将进一步迈向最终人类使用的系统。该奖项反映了NSF的法定任务，并被认为是值得通过基金会的知识分子优点和更广泛影响的评论标准来评估值得支持的。