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Edwards Lifesciences launches transcatheter heart valve platform in India

Edwards’ balloon-expandable transcatheter heart valve incorporates a proprietary calcification-resistant tissue technology that helps prevent calcium buildup on the valve leaflets

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Edwards Lifesciences has announced the launch of its transcatheter heart valve platform in India for the treatment of aortic stenosis. This advanced therapy is designed to meet the needs of patients who are not candidates for open-heart surgery.

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 per cent 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’ 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.

The proprietary calcification-resistant tissue has demonstrated 99.3 per cent freedom from structural valve deterioration (SVD) at 7 years and significantly lower rates of SVD, reoperation due to SVD, and all-cause reoperation at 8 years compared to  valves without calcification-resistant tissue.

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.

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.”

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