PRNewswire
Singapore, May 4: Edwards Lifesciences, the leading global structural heart innovation company, recently announced 10-year results from the COMMENCE aortic trial, reinforcing the long-term durability and sustained performance of its proprietary RESILIA tissue. The data were presented at the 106th American Association for Thoracic Surgery Annual Meeting.
Valvular heart disease continues to pose a significant and growing burden on healthcare systems across the Asia-Pacific region. As clinical evidence increasingly supports earlier intervention in the valve disease pathway, the need for long-term durable valve solutions continues to grow.
"By extending the evidence base to 10 years, these data further support the long-term durability and performance of RESILIA tissue," said Vikram Jaisinghani, Senior Director, Medical Affairs, Asia-Pacific, Edwards Lifesciences. "The COMMENCE trial provides prospective, 10-year durability data that contribute to the evidence base supporting lifetime management for patients with aortic stenosis."
At 10 years, COMMENCE trial data showed that patients treated with Edwards' surgical valves featuring RESILIA tissue experienced:
- 97.9% freedom from structural valve deterioration (SVD)
- 97.8% freedom from reoperation due to SVD
- 98.6% freedom from non-structural valve dysfunction (other than PVL)
- Sustained hemodynamic performance, including stable gradients and effective orifice area over time
For patients, long-term durability matters because it can reduce the likelihood of repeat procedures over a lifetime, helping preserve quality of life as life expectancy increases. "As bioprosthetic valves are increasingly used in younger and lower-risk patients, many of whom lead active lifestyles and wish to avoid anticoagulation, plus their ascending life expectancy, long-term durability has become a central consideration in surgical decision-making," Dato' Seri Dr. Jeffrey Jeswant Dillon, Senior Consultant Cardiothoracic Surgeon at Institut Jantung Negara (IJN), Kuala Lumpur, Malaysia added. "From a clinical practice perspective, minimal structural valve deterioration observed at 10 years provides important confidence for long-term treatment planning and may help reduce the need for repeat interventions over a patient's lifetime."
Building on nearly 70 years of leadership in structural heart innovation, Edwards has established a strong body of clinical evidence supporting the evaluation of valve performance, durability and treatment options in severe aortic stenosis. Developed more than two decades ago to address the need for improved durability in bioprosthetic valves, RESILIA tissue technology is now incorporated across a broad range of Edwards' surgical and transcatheter platforms, supporting aortic and mitral surgical valve replacement, aortic valve conduit procedures, and transcatheter treatment in the aortic position.
Within this context, the COMMENCE trial builds on the totality of Edwards' clinical evidence, further reinforcing the durability of outcomes supporting its surgical and transcatheter therapies, alongside large, randomized, FDA-approved studies such as the PARTNER series of trials.
The PARTNER trial series advanced the field with long-term patient outcomes on treatment with Edwards TAVR and SAVR, with 10 years of follow-up data. The new COMMENCE trial data build on that foundation with the latest evidence on the long-term durability of RESILIA tissue.
To date, more than 500,000 patients worldwide, including over 30,000 in the Asia-Pacific region, have been treated with Edwards' surgical and transcatheter innovations featuring RESILIA tissue1.
"This significant advancement in tissue technology underscores Edwards' long-standing commitment to pioneering innovation and advancing long term patient outcomes across Asia-Pacific," said Amit Raheja, Senior Vice President, Asia-Pacific, Edwards Lifesciences. "As Asia-Pacific becomes an increasingly important region for Edwards, we continue to invest in clinical evidence and regional capabilities to support sustainable growth and improved patient care. The availability of robust 10-year clinical data helps ensure that clinicians in the region are equipped to make informed treatment decisions that benefit patients over their lifetime."
1. Based on cumulative internal sales data for Edwards surgical and transcatheter heart valves incorporating RESILIA tissue in the Asia Pacific region
About Edwards Lifesciences
Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.
Edwards, Edwards Lifesciences, the stylized E logo, COMMENCE, PARTNER and RESILIA are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
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