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.

这个小企业创新研究 (SBIR) 第一阶段项目开发了一种新型医疗设备，可实现三尖瓣的微创手术翻修和修复。美国有超过 160 万患者患有中度至重度三尖瓣反流 (TR)，到 2028 年，市场规模将超过 24 亿美元。这种修复的患病率随着年龄的增长而增加，女性受影响的可能性是女性的 4 倍以上与TR相比男性。目前尚无美国食品药品监督管理局 (FDA) 批准的用于 TR 治疗的经皮设备。由于大手术与术后并发症相关的固有风险，导致严重 TR 患者的发病率和死亡率高达 36.1%，因此很少进行孤立 TR 手术。因此，目前美国所有中度至重度 TR 患者中只有约 8,000 名接受手术治疗。 这个小企业创新研究 (SBIR) 第一阶段项目开发了一种新型经皮导管设备和程序，用于对患有三尖瓣反流 (TR) 的患者进行三尖瓣修复手术。三尖瓣是四个心脏瓣膜中最大的一个，由于其复杂的解剖结构（包括 3 个薄瓣叶和位置）而面临着独特的挑战。使用传统的股静脉通路很难进入瓣膜。该项目旨在提供一种新型、薄型的导管和通过颈静脉的植入装置。第一阶段的目标包括展示抓取瓣叶的能力，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，以及进行经导管三尖瓣边缘到边缘修复（t-TEER）在实验室环境中通过颈静脉进行手术。来自技术开发、台架测试的结果。临床前模型将进一步推动该系统最终用于人类。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。