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ATLANTA, June 30 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), a biomaterials, medical device and tissue processing company, has announced that positive mid-term performance data on the CryoValve(R) SG decellularized pulmonary human heart valve were presented on June 28th at the 34th Annual Western Thoracic Surgical Association Meeting in Kona, Hawaii. The data, used earlier this year to support the marketing clearance for the valve, were presented by John W. Brown, M.D., professor of Cardiothoracic Surgery, Indiana University School of Medicine.
For the study, 342 patients who received a CryoValve SG processed using CryoLife's proprietary SynerGraft(R) technology were compared to 1,246 patients who received a conventionally processed CryoValve pulmonary heart valve. All patients received the valves in conjunction with either a right ventricular outflow tract (RVOT) reconstruction or as part of the Ross Procedure, which is described below. Average follow-up time was 3.9 years for the CryoValve SG RVOT procedure patients, and 4.7 years for the Ross Procedure patients. The average follow-up times were comparable for patients who received the conventionally processed CryoValve.
The results showed that there was a statistically significant reduction
in structural valve deterioration -- SVD (71 percent actuarial freedom from
SVD at five years for CryoValve SG versus 55 percent for CryoValve) and
valvular insufficiency (48 percent of patients with trivial or less
valvular insufficiency at last follow-up for CryoValve SG versus 30 percent
for CryoValve) in patients who received the CryoValve SG for RVOT
reconstruction as compared to the conventionally processed valve. Valvular
insufficiency occurs when the valve leaflets do
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