The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to introduce a new approach to cranial aneurysm treatment. Brain aneurysms affect ~2% of United States population. Ruptured brain aneurysms accounts for 75-80% of non-traumatic subarachnoid hemorrhage which are associated with high mortality rate in ~50% of cases. Due to serious consequences of aneurysm rupture, there is a pressing need for new treatments. This project will develop a product to aid in the healing of brain aneurysms. The expected outcomes of this grant is the production of the an aneurysm device that is optimal for feasibility and usability. In terms of clinical use, optimal feasibility translates to improved occlusion rates and aneurysm healing. For physicians, improved usability leads to device preference, shortened training time, and shortened procedure time. This Small Business Innovation Research Program (SBIR) Phase I project advances translation of a solution that takes into account the shape of the aneurysm, a different concept that separates this product from other intrasaccular flow disruptors. These specialized shapes conform to the geometry of brain aneurysms, providing better fit. This project will address three objectives: 1) Enhancement of the product system for safety and effectiveness. In this objective, the design characteristics of the product will be systematically tested to achieve optimal performance. 2) Test the product for usability and function, along with development of user focused sizing matrix. Neurosurgeons will test the product in a silicone model. Users will grade the system on performance. Flow dynamics will also be measured. 3) Characterize implantation and downstream effects in vivo. A study in rabbits will be conducted. If successful, results will be used as supporting evidence for human trials.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.
