Study backs Edwards aortic valve with Resilia tissue

17 May 2023
www.massdevice.com
Clinical ResultClinical StudyAACR
Data from the COMMENCE aortic trial demonstrated low rates of structural valve deterioration (SVD) in the bioprosthetic valves. It represents the longest clinical follow-up for Edwards’ valve with Resliia tissue at a mean of 7.7 years. The company presented data today at the 103rd annual meeting of the American Association for Thoracic Surgery. Resilia, a bovine pericardial tissue treated with anti-calcification technology, serves as the platform for Edwards’ new class of valves. Edwards launched the Sapien 3 valve with Reslia in September 2022. The company is using it while developing the next-generation Sapien X4 valve, which is currently undergoing clinical trials. The build-up of calcium may cause SVD, potentially impacting the long-term durability of bioprosthetic valves. Edwards says. It designed heart valves with Resilia tissue to address the calcification challenges of conventional tissue valves. The company’s Resilia technology could potentially enable valves to last longer. About the Edwards COMMENCE trial Edwards’ COMMENCE trial is a prospective, non-randomized, multi-center, single-arm investigational device exemption study. It evaluated 689 patients across 27 clinical sites in the U.S. and Europe, seeking to demonstrate safety and effectiveness of the valve with Resilia. The patients enrolled at 18 years old and up with diagnosed aortic valve disease, scheduled to undergo aortic valve replacement surgery. Edwards collected long-term follow-up data in a subset and plans to evaluate patients through 10 years. Data from the COMMENCE trial demonstrated low rates of SVD (99.3% freedom from SVD) and clinically stable gradients. It also showed freedom from reoperation — at a 97.2% clip — through seven years. “Edwards Lifesciences is committed to addressing the needs of patients with structural heart disease and our RESILIA tissue technology is designed for enhanced durability, supporting patients’ improved quality of life,” said Larry Wood, Edwards corporate VP and group president, transcatheter aortic valve replacement and surgical structural heart. “The latest COMMENCE aortic trial data emphasizes the value of RESILIA tissue-based offerings in helping patients and their physicians with lifetime management of valve disease.”
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-
Drugs
-
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.