|All materials used in the TTK Chitra Heart Valve go through a painstaking evaluation process. Finished valves are subjected to performance evaluation trials such as:
A specially designed computerized accelerated durability test system is used to validate the mechanical performance and wear of the valve in simulated use conditions for above 380 million cycles - which is equal to 10 years in actual use.
The TTK Chitra Heart Valve is also tested for its haemodynamic performance, which is an important factor in artificial heart valves. A comprehensive evaluation is also done through a computerized special purpose pulse duplicator and steady state and dynamic measurements are made for all sizes of the valve.
The results of all the tests conducted are comparable with the best international brands of mechanical Heart Valves and the TTK Chitra Heart Valve has been proven to equal the best international brand of mechanical heart valves.
All the materials used in the valve have undergone extensive toxicological and implant evaluation that is applicable to permanent implants.As per the ISO protocol for artificial heart valves, the TTK Chitra Heart Valve has passed through rigorous in vivo animal trials in sheep. During the trial, the valves were implanted in the mitral position without any anticoagulation regimen for the animals. The long time survival of these animals even under these difficult conditions was uneventful.
Based on the data obtained from the evaluations and trials, the ethics committee of the Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, chaired by a sitting judge of a high court of the land gave formal permission for controlled clinical trials in 1990. The TTK Chitra Heart Valve was implanted in a human for the first time in December 1990.
Six institutions in India took part in a multicentric trial that lasted till 1995. The trials were monitored by a national level monitoring committee, and the results were periodically presented at the annual conference of the society of the Indian Association of Cardiovascular Thoracic Surgeons. The ethics committee cleared the valve for commercial production during 1995.
Till August 2006, over 18,000 TTK Chitra Heart Valves has been implanted with excellent results. The valve has clocked over 40,000 cumulative patient years.