CryoLife Announces First Implantation Of CryoValve SG

(RTTNews) - Monday, CryoLife, Inc. (CRY | news | PowerRating | PR Charts ), a biomaterials, medical device and tissue processing company, announced the implantation of the first CryoValve SG pulmonary human heart valve since the product was cleared by the Food and Drug Administration, or FDA, in February.

CryoValve SG is indicated for the replacement of diseased, damaged, malformed or malfunctioning native pulmonary valves in pediatric and adult patients.

The company also noted that the valve could be used in conjunction with right ventricular outflow tract reconstruction procedures, commonly performed in children with congenital heart defects, and for pulmonary valve replacement during the Ross Procedure.

Further, at the FDA's request, CryoLife is planning a post-clearance study to seek evidence for the potential and implied long-term benefits of the SynerGraft process. Data to be collected is expected to include long-term safety and hemodynamic function, immune response and explant analysis.

CryoLife believes that this information may help it ascertain whether the SynerGraft process reduces the immunogenicity or potential for rejection of the transplanted heart valve and whether the valve recellularizes with the recipients' own cells.

CryoValve SG is processed with the company's proprietary SynerGraft technology, which removes allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix.

Charles Huddleston, who performed the implantation surgery, remarked, "The new technology was used in the patient in an effort to limit additional valve operations. We are very hopeful that the outcome with the CryoValve SG implant will last longer than the previous valve surgeries."

CryoLife, Inc. closed Thursday's regular trading session at $8.65.

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