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

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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.