CryoLife, a biomaterial, medical device and tissue processing company, has reported positive mid-term performance data on the CryoValve SynerGraft decellularized pulmonary, human heart valve, which 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, MD, professor of cardiothoracic surgery at the Indiana University School of Medicine in Indianapolis.
For the study, 342 patients who received a CryoValve SG were processed using CryoLife's proprietary SynerGraft (SG) technology, and compared to 1,246 patients who received a conventionally processed CryoValve pulmonary heart valve, Brown said. All patients received the valves in conjunction with either a right ventricular outflow tract (RVOT) reconstruction, or as part of the Ross Procedure.
The 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 Atlanta-based CryoLife reported. The average follow-up times were comparable for patients who received the conventionally processed CryoValve.
The company said its results showed that there was a statistically significant reduction in structural valve deterioration (SVD). Seventy-one 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, the researchers said.
Brown reported that the data also indicated that there was a statistically significant reduction in valvular insufficiency in patients who received the CryoValve SG as part of the Ross Procedure as compared to the conventionally processed valve (67 percent of patients with trivial or less valvular insufficiency at last follow-up for CryoValve SG versus 51 percent for CryoValve).
For all other measured mid-term clinical endpoints, the investigators said that there was no statistical difference between the CryoValve SG and the CryoValve recipients, including actuarial freedom from SVD at five years in patients undergoing Ross procedures, and for all patient groups there was no statistical difference between recipient groups for actuarial freedom from valve-related death at five years.
CryoLife said its proprietary SynerGraft technology is designed to remove allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix.