Medical devices and tissue processing company CryoLife Inc (CRY) has reportedly secured 510 (k) approval from the U.S. Food and Drug Administration (FDA) for a five-year shelf-life extension on its CryoPatch SG pulmonary human cardiac patch. The patch is indicated for the repair or reconstruction of the right ventricular outflow tract (RVOT) in children with congenital heart defects. The product was approved by the FDA for marketing in August 2009.
CryoPatch has been processed leveraging CryoLife’s proprietary SynerGraft technology, which is designed to remove allogeneic (genetically distinct) donor cells and cellular remnants from tissue. Since its launch, this specially processed tissue has broadened the application of the SynerGraft technology in additional human tissues and cells.
In contrast to conventionally processed pulmonary cardiac tissues, CryoPatch SG mitigates the risk of alloantibodies (an intrinsic component of the immune response to organ transplants) as measured by the Panel Reactive Antibody (PRA) blood test conducted on patients awaiting a transplant.
Patients with high PRA score are less likely to receive transplants given the high risk of rejection. As such, prevention of high PRA is critical for receivers of CryoPatch SG, who eventually require a heart transplant.
CryoLife is a leader in the processing and distribution of implantable human tissues for use in cardiac and vascular surgeries across the U.S. and Canada. Increased shipment of its heart valve products and cardiac patches contributed to a mid single-digit growth in cardiac revenues for first-half fiscal 2010.
The self-life expansion of CryoPatch SG should broaden its addressable market by means of covering additional patients. Moreover, this will facilitate the hospitals to streamline tissue inventory management and simplify their purchase decisions. The U.S. market for CryoPatch SG and related products for the repair or reconstruction of RVOT is estimated at roughly $15 million.
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In contrast to conventionally processed pulmonary cardiac tissues, CryoPatch SG mitigates the risk of alloantibodies (an intrinsic component of the immune response to organ transplants) as measured by the Panel Reactive Antibody (PRA) blood test conducted on patients awaiting a transplant.
Patients with high PRA score are less likely to receive transplants given the high risk of rejection. As such, prevention of high PRA is critical for receivers of CryoPatch SG, who eventually require a heart transplant.
CryoLife is a leader in the processing and distribution of implantable human tissues for use in cardiac and vascular surgeries across the U.S. and Canada. Increased shipment of its heart valve products and cardiac patches contributed to a mid single-digit growth in cardiac revenues for first-half fiscal 2010.
The self-life expansion of CryoPatch SG should broaden its addressable market by means of covering additional patients. Moreover, this will facilitate the hospitals to streamline tissue inventory management and simplify their purchase decisions. The U.S. market for CryoPatch SG and related products for the repair or reconstruction of RVOT is estimated at roughly $15 million.
CRYOLIFE INC (CRY): Free Stock Analysis Report
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