Mumbai, India, September 5, 2025 – Edwards Lifesciences, a global leader in structural heart innovations, has announced the launch of its next-generation transcatheter heart valve platform in India, marking a significant milestone in the treatment of aortic stenosis. This advanced therapy is designed to meet the needs of patients who are not candidates for open-heart surgery, offering a durable, minimally invasive solution that supports long-term health and quality of life.
Aortic stenosis is a progressive, degenerative condition often linked to aging, caused by calcification of the aortic valve that restricts blood flow from the heart. Once symptoms appear, nearly 50% of patients face mortality within two years without timely intervention, underscoring the urgency of early diagnosis and treatment. According to the Global Burden of Disease study, in India, a large number of deaths are attributed to severe calcific non-rheumatic aortic stenosis.
Edwards’ latest-generation balloon-expandable transcatheter heart valve incorporates a proprietary calcification-resistant tissue technology that helps prevent calcium buildup on the valve leaflets, which is a primary cause of structural valve deterioration and the need for reintervention. The valve also features dry tissue storage, simplifying hospital workflows, and a taller, textured outer sealing skirt to reduce paravalvular leak.
Clinical data from one year’s experience with this platform versus its predecessors show:
● Lower all-cause mortality
● Reduced paravalvular leak
● Fewer life-threatening bleeding events
● Rare need for reintervention
The proprietary calcification-resistant tissue has demonstrated:
● 99.3% freedom from structural valve deterioration (SVD) at 7 years
● Significantly lower rates of SVD, reoperation due to SVD, and all-cause reoperation at 8 years compared to valves without calcification-resistant tissue
Central to Edwards’ approach is its ‘lifetime management’ principle, which prioritises comprehensive planning of a patient’s treatment journey from the initial procedure. A key component is the valve-in-valve technique, which enables the placement of a new transcatheter valve within an existing transcatheter valve or a degenerated surgical valve, should degeneration occur years later. This approach maintains a minimally invasive pathway and reduces the need for repeat open-heart surgery in patients requiring future interventions.
Commenting on the Edwards’ next-generation transcatheter heart valve platform, reputed cardiologists from India shared their perspectives. Dr. Ravinder Singh Rao, Interventional Cardiologist, Lilavati Hospital Mumbai said, “The newer transcatheter heart valve, which is more durable and long-lasting, will allow us to safely and effectively treat younger patients with severe aortic stenosis.”
“Durability is the key for evaluating any transcatheter heart valve. With a strong clinical record of proving to be the most durable valve in the market, the patients will benefit from long-term disease management with this launch,” remarked Dr. G. Sengottuvelu, Interventional Cardiologist, Apollo Hospital, Chennai.
Dr. A B Gopalamurugan, Interventional Cardiologist, MGM Healthcare, Chennai said, “We have waited a long time for this technology to reach India. With this launch, patients here will now have access to the best-in-class transcatheter heart valve technology, within the comfort of their own country.”
Mr. Parameswaran Nair, Country Leader of India and Southeast Asia at Edwards Lifesciences, commented: “At Edwards Lifesciences, we are deeply committed to pioneering innovations that redefine care for structural heart disease. By integrating minimally invasive techniques with exceptional durability, we are delivering therapies that meaningfully enhance survival and quality of life for patients with aortic stenosis in India. This milestone reflects our dedication to empowering
clinicians, expanding access to care, and addressing the distinct needs of younger patients requiring lifelong treatment strategies.”
As India faces rising cardiovascular disease rates and an aging population, Edwards Lifesciences continues to collaborate closely with clinicians and healthcare partners to expand access to transformative therapies. The company remains focused on helping patients live longer, healthier, and more active lives through cutting-edge cardiovascular solutions.
