The Tianox device was developed by Sarov scientists from FSUE RFNC-VNIIEF (an enterprise of the Rosatom State Corporation). It allows you to safely synthesize inhaled nitric oxide in a gas discharge directly from the ambient air, at the patient's bedside, while purifying the gas from the admixture of a by–product of therapy - nitrogen dioxide.
Inhalations with nitric oxide are extremely effective in intensive therapy of critical conditions caused by pulmonary hypertension in children and adults. In such clinical situations, the use of the device can be considered as a life-saving method of treatment, says Andrey Bautin, head of the NIL of Anesthesiology and Resuscitation of the Almazov NMIC, under whose guidance clinical trials are being conducted.
Now nitric oxide is obtained chemically at special stations and delivered to medical institutions in high-pressure cylinders. This has significant drawbacks: cylinders need to be purchased periodically, they are difficult to transport, the shelf life of nitrogen oxide in such a "package" is limited.
"The device has already passed technical tests in the laboratories of Roszdravnadzor and Rostest, sanitary-chemical and toxicological tests – in accredited centers. Tests of "Tianox" for compliance with more than 230 parameters were carried out. The results confirmed that it meets the requirements for safe use," said Alexander Shirshin, one of the developers, a leading researcher at the RFNC–VNIIEF.
Clinical trials of a new type of medical device using unique technologies are carried out in accordance with the order of the Ministry of Health of the Russian Federation dated 09.01.2014 No. 2n "On approval of the procedure for assessing the conformity of medical devices in the form of technical tests, toxicological studies, clinical trials for the purpose of state registration of medical devices". The necessary permits of the Ethics Committee of the Ministry of Health and the local Ethics Committee of the Almazov Center have been obtained.
A source: medvestnik.ru