The BDC Laboratories’ technical experts are active members of AAMI/ISO 25539 Standard Workgroup (WG3) which covers Endovascular Prostheses (Part 1) and Vascular Stents (Part 2). In addition, the team participates in the ASTM Endovascular Prosthesis Standards Committee that is continuously working toward establishing testing methods aimed at Stent Testing and Stent Graft Testing.
Our comprehensive internal stent & stent graft testing capabilities, per the respective published guidance documents, are presented below. In addition to the noted tests, BDC Labs excels in developing custom test methods specific to novel and unique endovascular technologies. Finally, all test programs can be executed at a level consistent with the data’s application to optimize efficiency in time and cost, ranging from abbreviated early stage development studies to final, formal regulatory submission studies.