CryoLife Inc., a life-science company involved in the development and commercialisation of cryo-preserved and tissue-engineered implantable heart valves, vascular and orthopaedic reconstruction grafts, and surgical adhesives, has filed a Premarket Approval Application (PMA) with the US Food and Drug Administration (FDA) for the CryoLife-O’Brien stentless porcine heart valve. The CryoLife-O’Brien heart valve is directed toward the adult aortic valve replacement market, currently estimated at over USD 250 million in the United States and complements the estimated USD 60 million per year pulmonary heart valve replacement market, of which CryoLife is the leading provider. The PMA is based upon the results of several hundred human implants performed in the European Union and Australia. The O’Brien stentless heart valve has been implanted in Europe since 1991. CryoLife Inc. has distributed the CryoLife-O’Brien heart valve in Europe since 1996 after the company was awarded a CE (product certification) Mark. The CryoLife-O’Brien stentless aortic heart valve was designed by the cardiac surgeon Mark F. O’Brien.