Medical device manufacturers are actively developing cardiovascular stents where the stent platform is fabricated from absorbable materials that are intended to degrade. Recently, the first fully absorbable coronary stent was evaluated by an FDA Advisory Panel (March 15, 2016). There are great regulatory challenges associated with evaluating the mechanical durability of absorbable stents, because methods for permanent stents cannot be directly applied to absorbable versions.
We recently initiated a project with the FDA and Maureen L. Dreher, Center for Devices and Radiological Health (“CDRH”) on Bending Fatigue for Fully Absorbable Stents. This project will develop and evaluate a non-radial durability method specifically designed to address the challenges of testing absorbable stents.