Tri-leaflet heart valve “TRICARDIKS”
Currently existing heart valve prosthesis products are divided into two major categories: mechanical and biological (tissue) valves.
Currently existing heart valve prosthesis products are divided into two major categories: mechanical and biological (tissue) valves. All biological valves, despite their advantageous hemodynamic properties, have one major limitation — durability. Average lifetime of a tissue valve is about 10 years. This prevents them from being implanted to patients with long life expectance or requires repeated implantations. Mechanical valves are highly durable and usually last for the life of the patient. However, they induce significant thrombosis in the patients, which requires lifelong consumption of anticoagulant drugs (or blood thinners), such as warfarin or heparin.
Additional side effects of mechanical valves include blood hemolysis (destruction of erythrocytes) and noise. Thus, none of the existing types of heart valve prosthesis is perfect and there is a large unmet medical need for the new generation of products.
New tri-leaflet mechanical heart valves “Tricardiks” developed by Roscardioinvest combine the best features of biological and mechanical valves.
The novel and unique engineering design of Roscardioinvest products offers a number of important advantages over existing products:
- valves “Tricardiks” are similar to natural heart valves. They have a tri-leaflet design, which ensures a true central flow with a decreased disturbance of blood due to steady movement of the leaflets.
- valves “Tricardiks” are designed to significantly improve patient’s quality of life. This will be achieved due to reduced consumption of anticoagulants by the patients, reduced noise, low blood hemolysis, and the elimination of the need for repeated implantations because of high reliability of the mechanical design.
- valves “Tricardiks” combine the best features of two major existing types of heart valve prosthesis: the durability of mechanical valves and the improved flow characteristics of tissue valves.
Clinical trials of new tri-leaflet heart valve TRICARDIKS are successfully finished in Russia. Trials were performed in 3 clinics:
- Bakulev Research Center for Cardiovascular Surgery
- Russian scientific center of surgery
- 3rd central clinic of Vishnevskiy, Russian Department of defense
On June 18th, 2007 the first implantation of new tri-leaflet heart valve “Tricardiks” was made by the main cardio surgeon of Russian Federation, member of the Academy Leo Bokeria in Bakulev Research Center for Cardiovascular Surgery. In all 41 tri-leaflet heart valves were implanted on may 2010.
Company Roscardioinvest got the registration and approval for manufacturing and marketing of tri-leaflet heart valve “Tricardiks” in Russian Federation.
DESCRIPTION OF TRI-LEAFLET HEART VALVE “TRICARDIKS”