est™ temporary Total Artificial Heart (TAH-t). The TAH-t is the only temporary total artificial heart in the world that has both FDA and CE approval for the treatment of severely ill patients with end-stage biventricular failure. SynCardia anticipates increased demand for the TAH-t upon FDA approval of its portable driver technology. Recent shifts in reimbursement policy by the Centers for Medicare and Medicaid Services (CMS) are also anticipated to increase demand for the TAH-t. SynCardia has contracted PADT to provide engineering services on the development of the next-generation of implants. According to Mike Gaul, Chief Operating Officer of SynCardia;
“PADT is providing engineering expertise to help us develop our next-generation of total artificial hearts. Their medical device testing and CFD fluid-flow modeling capabilities are providing valuable insight into the performance of these products.”
SynCardia has a small 50cc TAH-t, under development, which is targeted for patients with a body surface area (BSA) of 1.0 to 1.7, to complement the existing 70cc TAH-t, which is generally used for patients with a BSA of 1.7 or greater. In addition, SynCardia is developing Pediatric Ventricular Assist Devices (VADs). The 10cc and 30cc VADs are intended to be short term devices that in some cases allows the native heart to fully recover.
PADT is well equipped to develop innovative cardiovascular medical devices. These devices have a host of challenging design requirements including biocompatibility, fluid dynamics, and difficult geometric constraints. PADT’s experience with these challenges is proving valuable to customers like SynCardia. Contact us for more information about PADT’s expertise in the development of cardiovascular related medical devices.
