The COMMENCE study shows that bioprosthetic surgical aortic valves with RESILIA tissue platform continue to demonstrate favorable safety and hemodynamic performance through four years follow-up. Edwards Lifesciences.

Edwards Lifesciences Corporation announced results from the COMMENCE clinical study. The data show that Edwards' bioprosthetic surgical aortic valves featuring the company's novel RESILIA tissue platform continued to demonstrate favorable safety and hemodynamic performance through a median of four years follow-up, with no events of structural valve deterioration (SVD).

The COMMENCE study enrolled 694 patients, 144 (21 percent) of which were under the age of 60 when they had surgical valve replacement. The data were presented at the American Association for Thoracic Surgery's (AATS) 99th annual meeting.There were no cases of early or late structural valve deterioration or valve thrombosis.

The trial enrolled 694 patients age 18 and older with diagnosed aortic valve disease and scheduled to undergo aortic valve replacement with or without coronary artery bypass graft (CABG). The COMMENCE trial is a PMA-approved study designed to evaluate the safety and effectiveness of surgical aortic heart valves with RESILIA tissue in this patient population for up to five years, with a subset of patients being evaluated through 10 years. At this stage, the study has recorded 2,533 patient-years of follow-up. Additional five-year data from a European feasibility study of a bioprosthetic aortic valve with RESILIA tissue were presented last month at the Heart Valve Society Annual Meeting. This study, a prospective, single-arm observational clinical trial of 133 patients conducted at two clinical sites in Europe, also yielded positive results. There were no events of structural valve deterioration throughout the study period.