Edwards Lifesciences’ five-year follow-up data for its bioprosthetic surgical aortic valve show favorable safety and hemodynamic performance.
The Irvine, CA-based company presented study results from the COMMENCE clinical trial during the 57th annual meeting of the Society of Thoracic Surgeons.
The COMMENCE trial is a study of Edwards’s Resilia tissue aortic valve in 689 patients at 27 clinical sites across the U.S. and Europe. Patients in the trial were 18 and older with diagnosed aortic valve disease and scheduled to undergo aortic valve replacement surgery. Data were collected for a total of five years and a subset of these patients will continue to be evaluated through 10 years.
Results show there were no incidences of structural valve deterioration (SVD) at the five-year review mark, a key safety outcome.
Edwards said the RESILIA tissue is specially formulated using a proprietary integrity-preservation technology that may eliminate a key factor in calcification leading to valve deterioration.
"There continues to be a significant focus placed on tissue valve durability given the increase in life expectancy and lifestyle implications for more active patients who historically would receive mechanical valves," said Joseph Bavaria, M.D., lead enroller and site principal investigator for the COMMENCE study and the Brooke Roberts-William M. Measey professor of surgery and vice chief of the division of cardiovascular surgery, University of Pennsylvania. "The latest data from the COMMENCE study are encouraging and speak to the promise of RESILIA tissue as a significant advancement in technology for patients with valve disease."
The COMMENCE data could be viewed as refreshing news for Edwards as it reported recently missing Wall Street Expectations for its 4Q20 earnings. Edwards posted quarterly earnings of .50 cents per share missing a consensus of .53 cents per share. The TAVR pioneer noted COVID-19 caused earnings challenges.
“We expect continuing COVID-related challenges early in 2021, turning to a more normalized growth environment in the second half of the year,” Edwards Chairman and CEO Mike Mussallem said according to a Seeking Alpha transcript of the earnings call.