SBIR Phase I: A novel clot removal system for improved Venous Thromboembolism (VTE) thrombectomy outcomes

SBIR 第一阶段：一种新型血栓清除系统，可改善静脉血栓栓塞 (VTE) 血栓切除术的结果

• 批准号: 2233665
• 负责人: Michael Schaller
• 金额: $ 27.5万
• 依托单位: XTRACT MEDICAL, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2233665&HistoricalAwards=false
• 关键词: SBIR; Phase; novel; clot; removal

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel system for treating Venous Thromboembolism (VTE), a clot in the patient’s deep veins or pulmonary arteries which blocks blood flow, in a more effective manner. Each year 1.2 million Americans are affected by VTE resulting in 100,000 deaths, $10 billion of direct medical costs, and $69 billion of economic impact. Despite modern treatments and procedures over half of all patients diagnosed with VTE will suffer long-term complications including Post-Thrombotic Syndrome, resulting in functional disabilities and the inability to return to work within 10 years of diagnosis. The proposed system aims to improve the clinical effectiveness of mechanical thrombectomy procedures by removing clots and restoring circulation, thereby improving patient outcomes and reducing long term patient care costs.This Small Business Innovation Research (SBIR) Phase I project aims to demonstrate the feasibility of a novel catheter-based system for securing and removing clots during mechanical thrombectomies. The technology aims to effectively remove clots while being both atraumatic to the vessel with minimal blood loss, in order to significantly improve upon existing clot entrapment or removal approaches. The scope of activities includes developing a first-generation prototype and demonstrating the prototype enables the ingestion of large clot volumes without clogging nor causing damage to other vascular structures. The device will be designed and prototyped within the dimensions needed to fit within a clinically accepted catheter size and validated using preclinical bench-top and animal models across a wide variety of clot sizes, shapes and mechanical properties.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.

小型企业创新研究（SBIR）I期Boombolism（VTE）的更广泛的影响/商业潜力，这是患者深静脉或肺动脉中的凝块，可阻止血液流血，每年以更有效的方式1.2毫米美国人是1.2毫米的美国人。 IS是100,000人死亡，100亿美元的直接医疗费用，尽管有现代的受信任和一半的被诊断为VTE的患者的经济性，但经济上有690亿美元。恢复工作的功能性悬念10年诊断10年。在机械血栓切除术期间，新型导管固化和去除凝块。堵塞或造成其他血管结构的损坏，将设计和原型化，以适应临床上可接受的导管大小的尺寸尺寸，并在各种各样的凝块尺寸上进行动物模型。使用Toundation的智力优点和更广泛的影响审查标准。