I-Corps: Translation Potential of a Transcatheter Occlusion Device

Award ID: 2533589

This I-Corps project focuses on a minimally-invasive medical device designed to prevent strokes in individuals with irregular heart rhythms who are unable to take blood-thinning medications. As the U.S. population continues to age, the prevalence of irregular heart rhythms, particularly atrial fibrillation, is rising significantly. This condition increases the risk of stroke due to clot formation in a small outpouching of the heart known as the left atrial appendage. While oral medications to prevent clotting are effective for many, a substantial portion of patients (up to one in five) are ineligible due to contraindications such as high bleeding risk. Without a safe and effective alternative, these patients face elevated risks of life-threatening complications. Existing mechanical closure devices are rigid and metallic, often poorly suited to the highly variable anatomical structure of the left atrial appendage, and have been linked to adverse outcomes. This project explores a new approach involving a soft, adaptable closure method intended to improve patient safety, reduce healthcare costs, and increase access to life-saving stroke prevention for a vulnerable patient population. This I-Corps project utilizes experiential learning coupled with a first-hand investigation of the industry ecosystem to assess the translation potential of the technology. This solution is based on the development of a percutaneously delivered catheter system that accesses the heart through the vascular system and deposits a gel-based material into the left atrial appendage. Unlike traditional implantable metal devices, which are round and rely on mechanical fixation in an irregularly shaped structure, this system enables complete, conformal sealing by filling the space with a biocompatible gel that hardens in place. The design is engineered to minimize risks such as perforation, incomplete closure, and post-operative bleeding, while adapting to patient-specific anatomy. The technical advancement lies in the directional control of gel delivery, in-situ curing capability, and the elimination of long-term foreign metallic implants. 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.

NSF Program Director: Ruth Shuman