SBIR Phase II: Shape memory polymer AAA Endograft

This SBIR Phase II project aims to continue the development of novel endografts for percutaneous treatment of abdominal aortic aneurysms (AAA) using unique and proprietary shape memory polymer (SMP) technology. Abdominal aortic aneurysms are both common and lethal in the older population, affecting between 7 and 13 % of older persons (> 60 years), accounting for between 13,000 and 18,000 deaths per year in the US alone, and increasing in diagnostic prevalence as both diagnostic techniques improve and the population ages. Endovascular treatment using covered stainless steel or Nitinol stent-grafts is now the preferred option for AAA treatment. However, current devices are far from perfect, and complications from endovascular repair such as endoleaks, continued growth of the aneurysm, device migration, arterial dissections, and other problems persist at very high (> 25-35%) rates. Most if not all these problems can be traced to the inherent limitations of the materials used in current devices. We propose to continue the highly promising Phase I work with particular focus on four areas: finalize polymer formulation; develop methods to manufacture patient-specific endograft designs; finalize biocompatibility evaluation; and evaluate endografts in acute and chronic animal studies. Anticipated deliverables at the end of the Phase II project are a finalized polymer formulation particularly suitable for endografts, complete ISO 109993 biocompatibility evaluation, methods to manufacture patient-specific endografts, and comprehensive data on the acute and chronic vascular response of the shape memory polymer endografts. The broader impacts of this work lie in the development of the next generation of medical devices using advanced materials with characteristics that can be customized to the patient. The successful development of useful devices from such technologies should pave the way for a plethora of commercial opportunities including tissue-engineering applications whereby the seeds' of new tissues or organs can be incorporated into shape memory polymer devices and delivered using minimally invasive methods into the target site to eventually grow healthy tissue. The ability to fuse shape memory polymer technology with advanced three-dimensional imaging and automated manufacturing methods, such as rapid prototyping and stereo-lithography, promises to open up the exciting prospect of creating patient-specific devices within the operating suite; devices that once manufactured can be compacted in situ into a catheter and delivered immediately into the patient. Lastly, successful completion of the overall project should have immediate impact on a disease that is the 13th leading cause of death in the US, and consequently on human health.