For Immediate Release:
BDC Laboratories Releases Transcatheter Heart Valve Device Testing Technologies
May 20, 2011, Wheat Ridge, Colorado
Positive clinical outcomes for transcatheter aortic valve implantation (TAVI) from clinical trials presented at the American Association for Thoracic Surgery and the EuroPCR 2011 annual meetings were significant for the high-risk patient, ineligible for surgery with aortic valve stenosis. Further research and product development is currently ongoing worldwide to address complications associated with TAVI. To assist with this research effort, BDC Laboratories has released several technologies aiding medical device companies with their product testing for transcatheter heart valve devices.
Heart valve mechanical and functional design testing provides the ability to evaluate critical device characteristics and design parameters in a predictable, controlled, and reproducible manner to demonstrate how a device may perform in-vivo. Heart valve and endovascular stent device testing guidelines are outlined in greater detail in the ISO 5480 and ISO 25539 guidance documents, respectively.
Craig Weinberg PhD, one of the principals of BDC Labs said “These technologies will assist the medical device industry with effective, functional design assessment of TAVI implants. Our heart valve test equipment, coupled with BDC’s simulated use test systems can offer a comprehensive platform aiding in device durability, hydrodynamic performance, and delivery system evaluation.”