New Delhi, March 1 The second-generation Chitra heart valve has been implanted in 40 patients in the last two years as part of the pilot clinical evaluation in order to tackle Rheumatic heart disease, the Centre said on Friday.
Rheumatic heart disease, which leads to the damage of heart valves needing prosthetic replacement, is a challenge in India, the Ministry of Science & Technology said.
In the 1980s, based on the estimate of the Indian Council for Medical Research (ICMR), six out of every 1,000 children had rheumatic fever and the young population at risk for valvular disease was estimated at 12 lakh.
The first Chitra Heart Valve was successfully implanted in a patient in 1990, and subsequent efforts to improve upon and scale up the product have led to the clinical use of close to 2,00,000 devices. Based on the feedback from the clinical trials of the earlier model, and post-market surveillance, few improvements were identified and implemented in the second-generation device.
Responding to India's requirement for low-cost indigenous artificial heart valves, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), an autonomous institute of the Department of Science and Technology (DST), has developed the valve. After obtaining necessary regulatory approvals from the Central Drug Standards Control (CDSCO), the pilot clinical evaluation of the upgraded model TC2 was initiated in SCTIMST in the last two years and 40 valves were implanted in patients.
"The results are observed to be very promising and no specific complications were reported. Based on this positive outcome, a pivotal clinical trial has been planned and is expected to start by the end of 2024," the department said.
The prototyping and preliminary proof of concept studies have been completed.
The institute has initiated the identification of a suitable industrial partner for taking this product to the clinic which is expected by 2026.
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