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.

这个小型企业创新研究(SBIR)第一阶段项目开发了一种新型医疗设备，能够对三尖瓣进行微创手术翻修和修复。在美国，超过160万患者患有中到重度的三尖瓣反流(TR)，导致到2028年市场规模超过24亿美元。这种修复的患病率随着年龄的增长而增加，超过4岁的女性患TRR的可能性是男性的4倍。目前还没有食品和药物管理局(FDA)批准的经皮吸收治疗装置。由于与大手术相关的固有风险和术后并发症，单独的TR手术很少进行，在严重的TR患者中，其发病率和死亡率高达36.1%。因此，目前只有大约8000名美国中度至重度TR患者接受了手术治疗。这个小型企业创新研究(SBIR)第一阶段项目开发了一种新颖的经皮导管为基础的装置和程序，用于外科手术修复三尖瓣反流患者的三尖瓣。三尖瓣是四种心脏瓣膜中最大的，由于其复杂的解剖结构，包括3个薄叶和位置，提出了独特的挑战。使用传统的股静脉通路很难接触到这种瓣膜。该项目旨在提供一种新的、低轮廓的经颈静脉导管和植入装置。第一阶段的目标包括展示掌握瓣叶的能力，使用模拟人体条件的台式模型验证设计，进一步设计、开发和验证动物模型，以及在实验室环境中通过颈静脉执行经导管三尖瓣边缘到边缘修复(t-TEER)程序。结果由技术开发、台架试验得出。临床前模型将推动系统走向最终的人类使用。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，认为值得支持。