Rago A, Duggan MJ, Hannett P, Brennecke LH, LaRochelle A, Khatri C, Zugate GT, Chang Y, SharmaU, King DR. Chronic safety assessment of hemostatic self-expanding foam: 90-day survival study and intramuscular biocompatibility.
Summary: Noncompressible hemorrhage is a significant cause of preventable death in trauma, with no effective presurgical treatments. We previously described the efficacy and 28-day safety of a self-expanding hemostatic foam in swine models. We hypothesized that the 28-day results would be confirmed at a second site and that results would be consistent over 90 days. Finally, we hypothesized that the foam material would be biocompatible following intramuscular implantation.