Stent and Graft Testing Equipment

Ten-year FDA in vitro test requirements now take only weeks with the Stent/Graft Tester. The tester represents a third generation design and has become the standard by which other systems are measured. Implementing high-performance electro-dynamic pump technology, laser-based measurement techniques and the WinTest Control System, the system's performance, accuracy and reliability are unmatched.

The Stent/Graft Tester tests intravascular prostheses such as stents and stent grafts under simulated physiological loading conditions. The IDE submission requirements for these devices include in-vitro accelerated durability testing to 400 million compliance cycles. Stents and grafts are spring, wire mesh or slotted tubes deployed inside the coronary vascular system, providing structural support following angioplasty and other major medical procedures. They are relatively new devices and require the approval of the Food and Drug Administration (FDA) prior to commercial marketing. Medical device manufacturers must submit animal, clinical and in vitro test data to support a design's safety and efficacy.

The Stent/Graft Tester is designed for precise testing and features volumetric, pressure and temperature transducers to provide accurate monitoring and control of test variables. The transducer calibrations are traceable to NIST standards and a battery back-up power supply Uninterruptible Power Supply (UPS) ensures data integrity and smooth system shutdown if power failure occurs.

These systems can be used to tests stents, stent grafts, AAA & bifurcated devices, filters, occluders and other coronary and peripheral devices under exacting test conditions.

EnduraTEC Systems Corporation, 5610 Rowland Road, Minnetonka, MN 55343. Tel: 952-933-7742; Fax: 952-933-7744.