Upgraded Chitra Heart Valve Implanted in 40 Patients in Pilot Project
Friday, 01 March 2024, 18:12 IST
The Ministry of Science & Technology announced the successful implantation of the second-generation Chitra heart valve in 40 patients over the past two years as part of a pilot clinical evaluation targeting Rheumatic heart disease. This disease poses a significant challenge in India, with the Ministry highlighting its impact on heart valves and the need for prosthetic replacement.
Rheumatic heart disease has been a longstanding concern, with estimates from the 1980s indicating a high prevalence among children, leading to valvular disease in a substantial young population. In response to the need for cost-effective indigenous artificial heart valves, the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) developed the Chitra Heart Valve.
Since the successful implantation of the first Chitra Heart Valve in 1990, continuous efforts to enhance and scale up the product have resulted in nearly 200,000 devices being clinically used. The second-generation Chitra Heart Valve, an upgraded model known as TC2, underwent pilot clinical evaluation with regulatory approvals from the Central Drug Standards Control (CDSCO), and 40 valves were implanted in patients at SCTIMST over the past two years.
The outcomes of the pilot clinical evaluation have been promising, with no reported complications. Building on this success, a pivotal clinical trial is planned to commence by the end of 2024. The Sree Chitra Tirunal Institute is actively seeking a suitable industrial partner to advance the product, aiming for clinical availability by 2026.
Rheumatic heart disease has been a longstanding concern, with estimates from the 1980s indicating a high prevalence among children, leading to valvular disease in a substantial young population. In response to the need for cost-effective indigenous artificial heart valves, the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) developed the Chitra Heart Valve.
Since the successful implantation of the first Chitra Heart Valve in 1990, continuous efforts to enhance and scale up the product have resulted in nearly 200,000 devices being clinically used. The second-generation Chitra Heart Valve, an upgraded model known as TC2, underwent pilot clinical evaluation with regulatory approvals from the Central Drug Standards Control (CDSCO), and 40 valves were implanted in patients at SCTIMST over the past two years.
The outcomes of the pilot clinical evaluation have been promising, with no reported complications. Building on this success, a pivotal clinical trial is planned to commence by the end of 2024. The Sree Chitra Tirunal Institute is actively seeking a suitable industrial partner to advance the product, aiming for clinical availability by 2026.
