Pre-Clinical and Clinical Experience with Biodegradable Shape Memory Polyurethane Foam Occlusion Devices

Shape Memory Medical is a medical device startup located in Santa Clara, California that is commercializing a porous shape memory polyurethane (SMP) technology initially developed at Lawrence Livermore National Lab and Texas A&M University. These bi-stable materials can be delivered minimally invasively (via a catheter) in a compressed, programmed form factor for low friction delivery into blood vessels. Once deployed into the target anatomy, the shape memory effect causes the material to passively expand in the aqueous body temperature environment and conform to the vessel site for high volumetric filling. Acutely, the expanded porous foam structure causes the blood to slow down, and the high surface area foreign body material promotes rapid targeted clot formation. Chronically, the foam serves as a tissue scaffold to promote clot remodeling into healed tissue. As healing progresses, the material biodegrades and is replaced with native scar tissue. These unique material properties are being implemented in several commercial products for neurovascular vessel occlusion (aneurysms, fistulas, AVMS) and peripheral vessel occlusion (abdominal aneurysms, pelvic venous congestion, etc.). This presentation will outline the core technology principles, polymer degradation mechanisms, commercialization story, and pre-clinical/clinical implementation of SMP products.