Jun 15 2011
Endovascular stents, stent grafts, and transcatheter heart valve (TAVI) devices provide enhanced methods for clinical treatment of cardiac and vascular disease. Further research and product development is currently ongoing worldwide to address complications associated with these devices. BDC Laboratories has released new technology to aid the medical device industry with their product design testing by providing physiologic simulated use test systems.
Simulated use testing provides the ability to study critical stent, stent graft, and TAVI heart valve device delivery system characteristics and design parameters in a predictable, controlled, and reproducible manner. BDC Laboratories' simulated use test systems aid in the evaluation of product designs and delivery system parameters by emulating physiological hemodynamics and vascular or cardiac anatomy and compliance.
Key device attributes that can be evaluated with simulated use testing include pulsatile flow device interactions, stent, stent graft, and cardiac device implant positioning, implant deployment accuracy, implant sizing, conformability of the implant to the vessel wall, heart valve in valve deployment, delivery system trackability, pushability, and torquability as outlined in the ISO 25539 and ISO 5840 guidance documents.
Craig Weinberg, Ph.D., one of the principals of BDC Labs said, "Our technology will assist the medical device industry with their functional design testing for stents, stent grafts, and transcatheter heart valve devices. BDC's simulated use test systems provide an easy, controlled, and cost-effective means for R&D engineers to assess their technologies in a clinically relevant manner."