New Delhi: The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) has emerged as a beacon of innovation with its low-cost Chitra Heart Valve, aiding in the battle against Rheumatic Heart Disease (RHD) and marking a monumental step towards a Swasth Bharat.
Originating in the early 1990s, the Chitra Heart Valve has undergone continuous refinement, with the latest iteration witnessing commendable success rates, comparable to other heart valves available in the market. This development is crucial in addressing the challenge posed by RHD in India, where the prevalence of rheumatic fever among children and the population at risk for valvular diseases was alarmingly high in the 1980s.
To counter the prohibitive costs associated with importing artificial heart valves, SCTIMST, an autonomous institute under the Department of Science and Technology (DST), established a multidisciplinary team to create an indigenous, affordable solution.
The initial Chitra Heart Valve model, developed in 1990, marked the beginning of a transformative journey. The valve, featuring an ultrahigh molecular weight polyethylene (UHMW-PE) disc and a Haynes-25 alloy cage, showcased innovative design elements aimed at minimizing thrombosis formation and reducing operational sound levels. Subsequent iterations, driven by feedback from clinical trials and post-market surveillance, introduced enhancements like improved MRI compatibility, enhanced thrombo-resistance, and larger effective orifice areas.
Pilot clinical evaluations of the latest model, TC2, over the last two years have shown promising results, with no reported complications. Following regulatory approvals, a pivotal clinical trial is set to commence by the end of 2024.
With an eye on the future, as prophylaxis efforts strengthen at the community level, it is anticipated that the demand for heart valve replacements will shift from rheumatic heart disease to degenerative diseases. Acknowledging this shift, SCTIMST has initiated a tissue valve development program, with prototyping and preliminary proof of concept studies completed. A suitable industrial partner is being sought to bring this product to clinics by 2026.
This remarkable journey of development and commercialization is not only an exemplar of frugal innovation but also a testament to the success of an ecosystem leader co-creating an innovation ecosystem. The core team, led by Shri C.V. Muraleedharan, Dr. P.R. Umashankar, and Dr. Vivek V. Pillai, has played a pivotal role in India’s pursuit of inclusive healthcare through groundbreaking frugal innovations.
As India continues its march towards a healthier nation, the Sree Chitra Valve stands tall as a symbol of indigenous ingenuity and a key player in the country’s healthcare evolution.