A NEW HYPOTHERMIC STORAGE SOLUTION FOR VENOUS SEGMENTS

Organ Recovery Systems, Inc., Charleston SC

Investigators

Abstract

It is common practice to store autologous vein segments during vascular and cardiovascular reconstructive surgery for brief periods before implantation of vein grafts. Clinical studies have documented the sensitivity of these vein segments to handling, temperature and the solution employed. We propose feasibility testing of a new hypothermic storage solution, Unisol(TM), originally designed as a universal solution for tissue and organ preservation, for short-term storage of autologous vein segments during surgery. In a Phase I study, pre-implantation studies of histopathology and smooth muscle/endothelial cell physiology will be performed to compare fresh rabbit veins with veins stored in Unisol solutions, Viaspan, saline and autologous blood for varying periods of time at either 25 degrees C, or 4 degrees C. This study will determine the hypothermic storage conditions that enhance the endothelial structure and function of vein segments in vitro. Implantation experiments in established animal models will be proposed in a Phase II study. The optimized interactive variables of solution composition, time of storage and temperature will be further fine-tuned in a Phase II study designed to yield an effective and convenient paradigm for improved preservation of grafts for a large animal pre-clinical model and ultimately clinical application. PROPOSED COMMERCIAL APPLICATION: The US market for a hypothermic storage solution for veins is between 300,000 and 400,000 units annually, i.e., all coronary vein grafts and all free, reversed peripheral vein grafts performed.