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Don Marlowe discusses procedures for durability testing of prosthetic
heart valves with Committee F04 Vice Chairman Dan Chwirut in OST's
engineering laboratories. Since the long-term durability of medical
implants can never be determined a priori by clinical trials,
most implants are subjected to accelerated bench testing prior
to FDA approval. Mechanical heart valves, while expected to last
indefinitely in vivo, are tested at severely elevated pressures
for 600 million cycles (15 years equivalent). Manufacturers generate
the data, for FDA review and approval, in accordance with test
methods developed as consensus standards.
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