Non FDA-approved devices

[ChouDoufu]

for upcoming avr, procedure will be performed outside the us, so fda approval
of implant is not necessarily required. yes, i know, approval is a good thing.

as the approval process is so long and complicated, many things including drugs, therapies, implants, etc., become available elsewhere before making
it to the us, if they ever do.

anyone know of new, or not available in the us, aortic valves? currently
leaning towards the edwards perimount magna, but if i can find something
better, i should at least look into it.

 

[dtread]

Sorin Biomedica, www.sorinbiomedica.com makes mechanical valves called Bicarbon Fitline, Bicarbon Slimline, Bicarbon Overline, and Carbonart. None of these mechanical valves are approved for use in U.S. Sorin Biomedica also makes several biological (i.e., Bovine) valves, including the Freedom Solo, Pericarbon Freedom Stentless, Soprano, and the Pericarbon More Aortic and the Pericarbon More Mitral. None of these biological valves are approved for use in the U.S. either.