SBIR Phase II: Shape memory polymer AAA Endograft

Period of Performance: 01/01/2008 - 12/31/2008

$451K

Phase 2 SBIR

Recipient Firm

EndoShape Inc
2450 Central Avenue, Suite I
Boulder, CO 80301
Principal Investigator

Abstract

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