Novel Fatigue-to-Fracture Technology for Super-Elastic Alloy in Cardiac Pulsatile Loading Mode

With regulatory scrutiny of medical devices on the rise, increased attention is being placed on the long-term safety and performance of permanent implants. State-of-the-art standards like ASTM F2477, Standard Test Methods for In Vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses, and ISO 25539-2, Cardiovascular Implants—Endovascular Devices—Part 2: Vascular Stents, for example, provide historical frameworks for empirically demonstrating adequate durability of vascular stents. Subsequent guidances have been published, which are gaining traction as complementary tools supporting the collective framework of long-term permanent implant understanding. ASTM F3211, Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices, for example, outlines elegant methodologies for fatigue-to-fracture of cardiovascular medical devices. Some challenges that ensue, however, are apparent in exceptionally durable super-elastic alloys, like nitinol, where equipment limitations become rate limiting. Furthermore, once hyperphysiological loading levels are achieved, the subsequent challenge of fracture detection arises. Partnering with Dynatek Labs, Inc., Cook Medical presents a novel pulsatile fatigue testing platform capable of both applying hyperphysiological load levels, which induce fracture, as well as detecting fractures when they occur. Coupled with sophisticated statistical analysis projections, these pulsatile fatigue-to-fracture data align with cutting-edge standards like ASTM F3211 and provide confirmatory evidence of long-term permanent implant durability predictions associated with state-of-the-art standards of ASTM F2477 and ISO 25539-2.