FDA Clears CryoLife’s ‘Decellularized’ Heart Valve

By Anna Boyd
12:55, February 8th 2008
65 votes
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FDA Clears CryoLife’s ‘Decellularized’ Heart Valve

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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