The BDC team is involved in the ISO committee (WG8) that has been drafting the upcoming standard for Cardiac Occluders by contributing our years of experience in evaluating these technologies, including: Septal Occluders and Left Atrial Appendage (LAA) Occluders. BDC Laboratories experience can be brought-to-bare for both acute bench testing, such as acute particulate and radial force, as well as durability testing of the implant and associated covering. In addition, as experts in the field of testing stents and stent grafts, the BDC team can execute the frame fatigue and structural assessment requirements of cardiac occluder technologies.
Our cardiac occluder implant testing capabilities, per the published guidance documents are listed below. In addition to these outlined tests, BDC is capable of supporting all aspects of the device evaluation, including developing the testing strategy, establishing protocols, validating methods, performing data analyses and providing regulatory quality final reports. 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.