SBIR-STTR Award

Hemorrhagic stroke following aneurysmal rupture represents 15% to 30% of all strokes, with greater than 40,000 deaths per year attributed to acute aneurysmal rupture in the United States alone. Additionally, another 28,000 to 36,000 acutely ruptured aneurysms are treated per year in the U.S. The incidence of an intracranial aneurysm in the general population has been estimated to be between 1.5% to 8%. Current treatment options for cerebral aneurysm fall into two categories: surgical and interventional. Surgical procedures involves a long, delicate operation that has significant risk and a long period of postoperative rehabilitation and critical care. Recently, with the advent of neuro-interventional devices such as the Guglielmi detachable platinum coils (GDCs), a new endovascular modality for the treatment of cerebral aneurysms has become available. Our goal is to develop an endovascularly placed polymer aneurysm filler technology for treatment of aneurysms that is designed to address the shortcomings of interventional aneurysm treatment with platinum coils. We are developing a polymer filler material to be delivered in much the same way that a metallic coil is implanted. We anticipate that a packing density of at least 70% can be achieved. This substantially greater filling capability combined with the polymeric surface and surface coating technologies will allow for permanent healing at the neck of the aneurysm. PROPOSED COMMERCIAL APPLICATIONS: The new polymer aneurysm filler device proposed here is founded on a novel concept for the polymeric filling and healing of aneurysms. It will serve as a next generation interventional treatment for aneurysms. The market for detachable metallic aneurysm coils is currently $170 million per year. Our device system would represent a significant new product in this marketplace. Furthermore, as the treatment of aneurysms matures, we anticipate a greater penetration of treatment of the 1.5% to 8% aneurysms in the population rather than just those acutely symptomatic aneurysms.

Hemorrhagic stroke following aneurysmal rupture represents 15% to 30% of all strokes, with greater than 40,000 deaths per year attributed to acute aneurysmal rupture in the United States alone. Additionally, another 28,000 to 36,000 acutely ruptured aneurysms are treated per year in the U.S. The incidence of an intracranial aneurysm in the general population has been estimated to be between 1.5% to 8%. Current treatment options for cerebral aneurysm fall into two categories: surgical and interventional. Surgical procedures involve a long, delicate operation that has significant risk and a long period of postoperative rehabilitation and critical care. Recently, with the advent of neuro-interventional devices such as the Guglielmi detachable platinum coils (GDCs), a new endovascular modality for the treatment of cerebral aneurysms has become available. Our goal is to develop an endovascularly placed polymer aneurysm filler technology for treatment of aneurysms that is designed to address the shortcomings of interventional aneurysm treatment with platinum coils. We are developing a polymer filler material to be delivered in much the same way that a meallic coil is implanted. We anticipate that a packing density of at least 70% can be achieved. This substantially greater filling capability combined with the polymeric surface and surface-coating technologies will allow for permanent healing at the neck of the aneurysm.

Thesaurus Terms:
biomaterial development /preparation, cerebral aneurysm, implant, polymer, stroke therapy biomaterial interface interaction, biomedical equipment development, cerebrovascular occlusion, disease /disorder model, nonhuman therapy evaluation, surface coating medical implant science, swine