Arizona-based SynCardia Systems announced this week that it won FDA approval for its SynHall valves, which the company called "the last key component to manufacture the Total Artificial Heart."
The SynHall devices are largely identical to the tilting-disk valves always used in the SynCardia heart, but the FDA win gives the company control over the valves themselves as well as the proprietary formula for materials necessary to manufacturing.
The Total Heart system relies on segmented polyurethane solution (SPUS), a material that SynCardia acquired in June 2011 when it purchased the formula, reactor and exact manufacturing equipment for making the material.
"Fatigue resistance, strength and biocompatibility make SPUS ideally suited for the blood contacting and flexing components of the SynCardia Heart and other medical devices," according to SynCardia. "For over 30 years it has been used for the housings, diaphragms and connectors of the Total Artificial Heart."
"SynCardia is the only source of SPUS in the world," the company noted.
The artificial heart maker is on a roll, having just won FDA approval for its Freedom driver, a portable power driver that allows patients to take their artificial heart systems out of the hospital. SynCardia is also pursuing approval for the SynCardia total artificial heart as a destination therapy rather than just a bridge to transplant. The company late last year also raised $14 million to support efforts to develop a smaller artificial heart system.