ATLANTA, Jan. 11 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), a biomaterials, medical device and tissue processing company, announced today that it has been notified that a lawsuit will be filed against it in the Superior Court of Cobb County, Georgia relating to a meniscal allograft.
The lawsuit concerns an individual who contracted an infection following a transplant of a meniscal allograft in December 2006. Meniscal transplants are commonly used for patients with significant damage to the knee, who have already undergone several previous knee operations. A meniscal transplant is often recommended as the last resort before total knee replacement surgery. When a meniscal transplant is contemplated, it is routine medical procedure for the patient to be informed of the risks of transplant surgery, including the risk of infection from the transplanted tissue.
After receiving notice of the individual's infection, CryoLife conducted an immediate and thorough investigation of the manner in which the transplanted tissue was recovered and handled. As a result of this investigation, CryoLife believes that it handled the tissue in accordance with its procedures and in accordance with all applicable industry standards and regulatory requirements. Shortly after the infection was discovered, CryoLife notified the FDA of the incident, as it was required to do.
"We regret that this recipient experienced a problem following implant
of our aseptically-processed tissue. We wish him the best; however, it is
our understanding that his knee function was severely compromised prior to
his meniscal transplant. Regrettably, the lawyers representing this
individual have chosen to make untrue public statements against our company
|SOURCE CryoLife, Inc.|
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