The Supervisory Council of Russian Corporation of Nanotechnologies has approve project to produce bicuspid and develop tricuspid artificial heart valves. Total budget for the project is 1.488 billion rubles of which RUSNANO will provide 930 million rubles. The coinvestor, Moskovskaya Venchurnaya Kompaniya, a company of the Government of Moscow, will invest 186 million rubles.
As a result of project realization, current production of bicuspid heart valves will be expanded and small-batch production of innovative tricuspid heart valves will be initiated. The tricuspid heart valve, based on developmental work by company-applicant Roskardioinvest, has characteristics that closely resemble natural valves, particularly its ability to provide low resistance to blood flow and its low level of trombogenicity.
In addition to distinctions in the valve’s construction, the technology for measured nanolayered implantation of carbon in a titanium ring makes the tricuspid valves unique. The precision composite carbonaceous layer has excellent biocompatibility. Moreover, it lowers thrombosis and provides a barrier that keeps metal ions of the titanium ring from getting into the organism.
The project is expected to run for 10 years. Production of the bicuspid valve is to begin in the second quarter of 2010. In the second quarter of 2011, production of the tricuspid valve with pyrolytic carbon cusps will start. In the second half of 2012, the project company plans to produce a tricuspid valve whose cusps are made of polyamide.
Production of valves within the project will rise from 500 units in 2010 to more than 40,000 in 2019. Sales will be oriented toward the domestic market and markets in CIS and European Union countries, China, and India. About 75 percent of the valves that are produced will be sold as exports in 2019.
The annual need for prosthesis of heart valves in Russia is estimated at 30,000 to 60,000 operations. Today only about 10,000 to 11,000 operations are carried out each year.
“Production of valves will be organized in Moscow and conducted in compliance with standards of good manufacturing practices for medical devices,” RUSNANO Managing Director Olga Shpichko noted. ”The project will engage international specialists to ensure that it meets those standards. Reconstruction of facilities that comply with GMP standards will be finished in July 2010.”
“We are going to create the world’s first artificial tricuspid heart valve that corresponds to the design of a natural valve,” Alexander Samkov, founder and general director of Roskardioinvest, said. “It will reduce the amount of drugs a patient must take, lower the coagulability of his blood, and greatly improve the quality of his life. We plan to sell the valves at a moderate price, affordable to a broad range of the population of the Russian Federation.”