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The U.S. Food and Drug Administration approved a heart valve
from Atlanta-based CryoLife that might lower the risk of rejection.
CryoLife Inc's CryoValve SynerGraft pulmonary valve will be
the first heart valve made from human tissue that has had cells removed.
Removing the tissue’s cells and cellular debris, the heart is designed to lower
the risk of an immune response from the body and subsequent tissue rejection,
the FDA said in its statement.
The new valve will be used for the replacement of diseased,
damaged, malformed or malfunctioning pulmonary valves.
The valve “will offer an attractive valve replacement option
for many children born with heart defects. [It] may also be a good option for
patients who have undergone valve replacement surgery as young children, but
may require another valve replacement as they’ve grown into adulthood,” Steven
G. Anderson, CryoLife’s president and chief executive officer said quoted by the
local Atlanta Journal Constitution.
He also said the company might be able to begin shipping the
product late in the first quarter of this year.
Before giving its approval, the FDA evaluated data comparing
342 of CryoLife’s experimental valves with 1,246 patients with traditional
human heart valves sold by the company. The FDA said it found that the new valves
were as efficient as the traditional ones, the FDA said.
CryoLife shares rose as much as 14 percent on the New York Stock Exchange
before easing to $7.47, still up a sharp 10.7 percent.
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