CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and cardiovascular tissue processing company, today announced that it has received a Humanitarian Use Device (HUD) designation from the Food and Drug Administration (FDA) for its CryoValve® SG aortic human heart valve. The HUD designation is the first step in obtaining a Humanitarian Device Exemption (HDE) for the CryoValve SG aortic human heart valve, which is processed with the Company's proprietary SynerGraft® technology. An approved HDE would allow the Company to market the CryoValve SG aortic human heart valve. The patented SynerGraft technology serves as the foundation for the next generation of implantable biological tissues and is designed to remove allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix.
An HUD is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States (U.S.) per year. An HUD can be granted when no comparable device with the same intended use is marketed through the premarket approval (PMA) process or the premarket notification (510(k)) process.
The CryoValve SG aortic human heart valve is intended to be used for the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic aortic valves in children from 0 to 21 years of age. The Company estimates that up to 1,500 children per year could benefit from this technology if the Company is successful in obtaining an HDE, which is the next step in making these valves commercially available in the U.S.
"The CryoValve SG aortic human heart valve may offer an attractive valve replacement option for many children with aortic valve disease. We plan to immediately begin conducting the bench and animal studies, as well as collecting the human clinical data necessary to apply for the HDE," said Steven G. Anderson, CryoLife's president and chief executive officer. "This HUD designation is an important first step toward expanding the use of our SynerGraft technology platform, which we believe is the foundation for the next generation of implantable biological tissues."
In February 2008, the Company received a 510(k) clearance from the FDA for its CryoValve® SG pulmonary human heart valve. The CryoValve SG pulmonary human heart valve is indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. The valve can be used in conjunction with right ventricular outflow tract reconstruction procedures (RVOT), commonly performed in children with congenital heart defects. In addition, the valve can be used for pulmonary valve replacement during the Ross Procedure, an operation in which a patient's defective aortic valve is removed and replaced with his own pulmonary valve. The CryoValve SG pulmonary human heart valve is then surgically implanted in place of the removed native pulmonary valve.
In August 2009, the Company received a 510(k) clearance from the FDA for its CryoPatch® SG pulmonary human cardiac patch. CryoPatch SG is indicated for the repair or reconstruction of the right ventricular outflow tract (RVOT), 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.
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