About FDA
Research Project: Preclinical Test Methods for Bioabsorbable Polymer Strength Retention
Bioabsorbable polymers are currently being used as raw materials for new orthopaedic and cardiovascular medical devices such as stents, spinal cages, and tissue engineered products that all experience complex mechanical loading. Despite the increased use of bioabsorbable materials in medical devices that provide structural support, current testing standards to evaluate degradation profiles do not specifically account for important physiologic factors such as mechanical load, media type, or cell exposure. Improved test methods would offer a test environment that more closely mimics in vivo factors. The primary objective for this project is to quantify the effect of mechanical load on the degradation and strength retention of bioabsorbable implants. To accomplish this goal, we are working to develop test methods that characterize the mechanics and chemical characteristics in bioabsorbable medical device forms exposed to mechanical loads and simulated degradation.







