Successful Clinical Trials of Congenital Heart Defect Device for Children Conducted in Russia

05 August 2019

GMP News

Russian scientists successfully conducted clinical trials of the world’s first congenital heart defect device for children. It is expected that the device will annually help over 2000 children who suffer from various heart conditions, including congenital heart defects.

According to Director of the Institute of Bionic Technologies and Engineering and one of the authors of the survey Dmitry Telyshev, the device was created for children from the age of 8, weighing over 14 kg who suffer from cardiomyopathy and other serious heart defects. At the moment, children whose heart is unable to pump the required amount of blood either receive medication therapy which is not very efficient or has to undergo heart transplantation abroad (pediatric heart transplantation is prohibited in Russia).

The new device consists of a pump and a turbine made from biocompatible materials including titan and bioprinted elements. The device installed into the thoracic cavity of a child drains a necessary amount of blood from the left ventricle of a heart and delivers it to the atrioventricular canal. The new cardiac device is due to be introduced into clinical practice at the beginning of next year after obtaining all the necessary patents and is expected to cost around 1.5 million roubles.



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