CryoLife nets 510(k) clearance for cardiac patch

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CryoLife, an implantable biological medical device and cardiovascular tissue processing company, has received 510(k) clearance from the FDA for its CryoPatch SG pulmonary cardiac patch.

The patch is processed with the company's SynerGraft technology designed to remove allogeneic donor cells and cellular remnants from tissue without compromising the integrity of the underlying collagen matrix, according to the Atlanta-based CryoLife.

CryoPatch SG is indicated for the repair or reconstruction of the right ventricular outflow tract, which is a surgery commonly performed in children with congenital heart defects, such as tetralogy of Fallot, truncus arteriosus and pulmonary atresia. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch.