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.

这项小型企业创新研究（SBIR）I期项目的更广泛的影响/商业潜力是治疗静脉血栓主义（VTE）的新型系统，该系统是患者深静脉或肺动脉中的凝块，以更有效的方式阻止血液流动。每年有120万美国人受VTE的影响，导致100,000人死亡，100亿美元的直接医疗费用以及690亿美元的经济影响。尽管现代疗法和程序中的一半以上的所有被诊断为VTE的患者将遭受长期并发症，包括后栓性综合征，导致功能障碍，并且无法在诊断后的10年内重返工作岗位。提出的系统旨在通过拆卸衣服和恢复流通，从而提高机械血栓切除术程序的临床有效性，从而改善患者的结果并降低长期患者护理成本。这项小型企业创新研究（SBIR）I阶段项目的旨在证明基于新型导管的系统，用于确保基于新型导管的系统，以确保基于机械和拆卸机械的机械式润滑型式趋训练型。该技术的目的是有效地删除部分，同时既有最小的失血量都对血管进行了影响，以显着改善现有的凝块夹带或去除方法。活动的范围包括开发第一代原型，并证明该原型可以摄入大凝块体积，而不会插入，而不会造成其他血管结构的损害。该设备将在适合临床接受导管尺寸的尺寸内进行设计和原型，并使用临床前台式和动物模型在各种凝块尺寸，形状和机械属性上进行了验证。该奖项反映了NSF的法规任务，并被认为是通过基金会的知识优点和更广泛的cribia criperia criperia criperia criperia criperia criperia criperia criperia criperia the Insportion the Pression。