Development of Novel Intra-aneurysmal Rapid Occlusion Device

PROJECT SUMMARY Intracranial aneurysms are present in approximately 6-10 million Americans. These aneurysms frequently result in rupture—a devastating outcome which is fatal in roughly 50% of cases. The standard technique for aneurysm treatment involves minimally invasive, endovascular treatment using platinum coils. While endovascular coiling of aneurysms is a proven method that is associated with better outcomes than open brain surgery, serious shortcomings remain. The most critical of these failures is due to insufficient packing of the aneurysm, resulting in “compaction” of the coil mass, a phenomenon which facilitates reopening of the aneurysm over time and necessitates retreatment. Another serious drawback of current coils relates to the inert nature of platinum which fails to promote endothelial growth. This significantly prolongs healing time and increases the likelihood of complications such as inflammation and recurrence. To address these issues and improve aneurysm healing, we have developed a device composed of a highly- fibered polymer jacket containing a radiopaque coil which is designed to provide an optimal platform for endothelialization: the ThromboTube. In our Phase I SBIR proposal, we validated the first generation ThromboTube in a well-established rabbit aneurysm model using Axium MicroFX Nylon fibered coils as the predicate device. The results were promising, demonstrating safety equivalence, higher neck healing score, no sign of compaction, greater endothelialization at the neck/parent vessel interface, and thrombus formation and cell growth over the entirety of the device rather than just at the points of contact with the aneurysm. In light of these promising results, we propose a Phase II SBIR application to expand upon our previous work and achieve commercialization of the ThromboTube. To meet these goals, we will carry out the following objectives: 1) prepare for 510(k) submission of the ThromboTube and begin small-scale manufacturing for a limited product launch; 2) establish a second generation device—the Gen2 ThromboTube—based on physician feedback from our Phase I SBIR; 3) compare the safety and efficacy of the Gen2 ThromboTube to Axium MicroFX fibred coils in an elastase-induced rabbit aneurysm model; and 4) submit a 510(k) application of the Gen2 ThromboTube. Completion of this proposal will result in a portfolio of commercially viable devices capable of accelerating healing and improving outcomes of both unruptured and ruptured intracranial aneurysms.PROJECT NARRATIVE Intracranial aneurysms are present in roughly 2% of citizens in the United States and frequently result in rupture—a catastrophic event that has a mortality rate of roughly 50%. Endovascular coiling is the most common method for treating intracranial aneurysms, but current methods promote aneurysm healing very slowly and are associated with alarming rates of recurrence and often require retreatment. To address this gap in clinical care and promote better patient outcomes, Neurogami Medical has designed a novel, highly-fibred coil system that promotes better endothelial coverage and faster aneurysm healing than the leading fibered coil system.