Images Courtesy: Department of Science and Technology
Rheumatic heart disease, which leads to the damage of heart valves needing prosthetic replacement, is a challenge in India. In the 1980s, based on the estimate of the Indian Council for Medical Research (ICMR), 6 out of every 1000 children had rheumatic fever and the young population at risk for valvular disease was estimated at 12 lakhs. The valves, which are the solution to the disease, needed to be imported at a very high cost and were not affordable to all.
Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), an autonomous institute of the Department of Science and Technology (DST), assembled a multidisciplinary team to take on the development challenge in response to India’s need for low-cost domestic artificial heart valves.
One example of how a well-executed innovation ecosystem is assisting India in combating rheumatic heart disease and advancing the nation’s progress towards Swasth Bharat is the inexpensive Sree Chitra valve.
In 1990, the valve was designed and the first implant was performed. The valve has been enhanced throughout time to guarantee higher performance and durability, even though the patient has lived for around thirty years in a healthy state since then.
The ultrahigh molecular weight polyethylene (UHMW-PE) disc, the Haynes-25 alloy cage, and the sewing ring made of warp knitted polyethylene terephthalate (PET) were all features of the first-generation Chitra heart valve type.
The design’s primary characteristics included a planoconvex disc with an inlet side flat for improved hemodynamics, a free floating disc that could rotate on its central axis to reduce the issue of thrombosis formation around the hinge area and distribute wear produced during its functioning over a larger surface, lower levels of impact forced during the closure of the valve compared to other mechanical valves, which resulted in lower operation noise levels and less disruption in the tissue metal interface, and reduced cavitation damage potential achieved by selecting a soft UHMWPE disc material.
A small number of enhancements were found and included to the second-generation device based on feedback from the clinical trials of the previous model and post-market surveillance. These include improved thrombo-resistance and decreased bare metal exposure to the bloodstream by coating the frame surface with titanium nitride (TiN), larger effective orifice area (EOA) and hemodynamic performance achieved through design modifications, and enhanced MRI compatibility by incorporating titanium alloy instead of Haynes 25 used in the previous model.
It is anticipated that these will increase the patient’s quality of life through improved performance and decreased problems. In the past two years, forty valves have been implanted in patients as a result of the pilot clinical evaluation of this model TC2, which was started at SCTIMST after receiving the required regulatory clearances from the Central Drug Standards Control (CDSCO). There have been no specific issues noted, and the findings are seen as highly encouraging. A key clinical trial has been prepared and is anticipated to begin by the end of 2024 as a result of this encouraging outcome.
It is anticipated that within a few decades, degenerative illnesses would overtake rheumatic heart disease as the leading cause of heart valve replacement, if community-level prevention is reinforced. As a result, there will probably be a rise in the number of elderly patients in need of valve procedures. India would require more tissue-based heart valves as a result of this. Under the Technical Research Centre (TRC) for Biomedical Devices programme, the institute started a tissue valve development programme in 2019.
The prototyping and preliminary proof of concept studies have been completed. In order to get this product into a clinic by 2026, the institute has started the process of finding a suitable industrial partner.
According to a paper published in October last year in the journal, Product Innovation Management, the development and commercialisation journey of this frugal innovation is an example of how an ecosystem leader co-created the innovation ecosystem that led to the development of a low-cost heart valve by engaging in three types of configuration boundary work—establishing ecosystem configuration, modelling ecosystem configuration, and expanding ecosystem configuration. It is also a shining example of how India is advancing affordable innovations to provide universal health care.
