Tri-leaflet 'TRICARDIKS' heart valve
Currently existing heart valve prosthetic devices are divided into two major categories: mechanical and biological (tissue) valves. All biological valves, despite their hemodynamic advantages, have significant limitation in durability. An average valve’s lifetime is about 10 years, what makes its implantation complicate to long lifespan patients, with possible re-implantations required. Mechanical valves are highly durable and remain intact for the whole patient’s life. However, they induce significant thrombosis in the patients, which requires lifelong consumption of anticoagulant drugs (or blood thinners), such as warfarin or heparin.
Side effects of mechanical valves include blood hematolysis (destruction of erythrocytes) and noise. Thus, none of the existing types of prosthetic heart valves is perfect and there is a large medical need for the generation new ones, which stays unmet.
New tri-leaflet mechanical ’Tricardiks’ heart valves developed by Roscardioinvest combine the best features of biological and mechanical valves.
Unique engineering design of ’Roscardioinvest’ valves has a wide range of advantages:
- 'Tricardiks' valves are similar to natural ones. They have a tri-leaflet design, which ensures central blood flow with a decreased disturbance of blood because of steady movement of the leaflets.
- 'Tricardiks' valves are designed to improve patient’s quality of life after implantation. This is achieved due to reduced consumption of anticoagulants by the patients, reduced noise, low blood haemolysis and the reduction of the need for re-implantations because of its high reliability.
- 'Tricardiks' valves combine the best features of two types of heart valve prosthesis: the durability of mechanical valves and the improved flow characteristics of tissue valves.
Clinical trials of new tri-leaflet 'Tricardics' heart valves have finished in Russia successfully. Trials have been carried out in 3 clinics:
- Bakulev Research Center for Cardiovascular Surgery
- Russian Scientific Center of Surgery
- Vishnevskiy 3rd Central Clinic at the Russian Defense Ministry
The first implantation of the 'Tricardiks' tri-leaflet heart valve was made in Bakulev Research Center for Cardiovascular Surgery on June 18th, 2007 by Leo Bokeria, cardio surgeon-in- chief in Russian Federation and member of the Russian Academy of Medical Sciences.41 tri-leaflet heart valves were implanted by May 2010.
Roscardioinvest’ got the registration and approval for manufacturing and marketing of tri-leaflet heart valve 'Tricardiks' in Russian Federation.
DESCRIPTION OF TRI-LEAFLET ’TRICARDIKS’ HEART VALVE