Edwards Releases 5-Year RESILIA Tissue Aortic Valve Study Data

Edwards released new COMMENCE clinical trial data that demonstrates Edwards’ surgical aortic valve with RESILIA tissue shows favorable safety and hemodynamic performance through five years of follow-up. The data was presented at the 57th annual meeting of the Society of Thoracic Surgeons.
 
“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 E. 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.”
 
There were no incidences of structural valve deterioration (SVD) at the five-year mark. SVD can be caused by a calcium buildup on the valve’s tissue or by other damage that impacts the valve’s long term durability. RESILIA tissue is formulated using a proprietary integrity-preservation technology that may eliminate a key calcification factor leading to valve deterioration.
 
“Beyond the COMMENCE study, Edwards continues to invest in research to examine different outcome measures to further validate the long-term performance and durability of RESILIA tissue,” said Daveen Chopra, Edwards’ corporate vice president, surgical structural heart. “Evidence from the COMMENCE trial adds to the growing body of research that demonstrates the value of innovative, RESILIA tissue-based technologies in transforming care for patients, especially more active patients.”
 
Current technologies utilizing this tissue include the INSPIRIS RESILIA aortic valve and the KONECT RESILIA aortic valved conduit, the first ready-to-implant solution for bio-Bentall procedures. In addition to its anti-calcification properties, RESILIA tissue also allows the valve to be stored under dry packaging conditions, facilitating ease of use in the operating room.
 
The COMMENCE study is a prospective, non-randomized, multicenter, single-arm investigational device exemption (IDE) trial comprised of 689 patients at 27 clinical sites across the United States and Europe. The trial evaluated the safety and effectiveness of Edwards’ RESILIA tissue aortic valve in patients ages 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. At this stage, the study has recorded data equivalent to 2,989 patient-years of follow-up.
 
Additional RESILIA tissue studies include:
 

• European feasibility study: a prospective, single-arm observational clinical trial that evaluated SVD in a cohort of 133 patients. There were no events of structural valve deterioration throughout the study period of five years.
• RESILIENCE clinical trial: an ongoing, first-of-its-kind study designed to assess calcium deposits as a way to potentially predict long-term bioprosthetic valve durability. The study will enroll up to 250 patients under the age of 65 at the time of surgery to examine incidence of valve deterioration from year five to 11 after surgery.