FDA okays Edwards' stentless bioprosthesis:
This article was originally published in Clinica
The US FDA has approved for sale Edwards Lifesciences' Prima Plus stentless tissue heart valve for replacing diseased or malfunctioning aortic heart valves. The Irvine, California-based company claims that approval of the porcine bioprosthesis provides Edwards with "the most complete line of tissue valve products in the US. "Stentless valves represent approximately 10% of all tissue valve replacements in the US," says Michael Mussallem, Edwards' chairman and CEO.
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