Almazov Centre is carrying out clinical trials of the Tianox nitric oxide device.
The device was developed by Sarov scientists from the Russian Federal Nuclear Centre – All-Russia Research Institute of Experimental Physics (a ROSATOM’s company) and is intended for the production of nitric oxide from atmospheric air and inhaled nitric oxide therapy for various diseases in children and adults.
Clinical trials are conducted in accordance with the Order of the Russian Ministry of Health. The medical device of a new type using new unique technologies is tested in humans. The necessary permits were obtained from the Federal Service for Supervision in Healthcare, the Ethics Committee of the Russian Ministry of Health and the local ethics committee of Almazov Centre.
Currently, nitric oxide is generated chemically at stationary sites and delivered to healthcare facilities in pressurized cylinders. It has a number of significant drawbacks: the need for periodic purchase of nitric oxide cylinders, complicated logistics and a limited shelf life of nitric oxide in cylinders.
The Tianox device is able to generate nitric oxide directly from atmospheric air during therapy. It eliminates the use of cylinders and significantly increases the availability of this treatment method in practical medicine.
“The device has successfully passed technical tests in the laboratories of Federal Service for Supervision in Healthcare and the Russian Testing and Certification Authority, sanitary-chemical, as well as toxicological tests in accredited centres. The results confirmed that the device meets the requirements for safe use,” explained Alexander Shirshin, one of the developers representing the Russian Federal Nuclear Centre – All-Russia Research Institute of Experimental Physics.
The developers train doctors to work with the device and monitor the use of the device in real setting.
“Tianox implements a unique opportunity for a safe bedside generation of inhaled nitric oxide. Besides, the by-product of therapy, nitrogen dioxide, is removed from nitric oxide. Nitric oxide inhalation is highly effective in the intensive care of critical conditions caused by pulmonary hypertension in children and adults. In these clinical cases, the use of this device can be considered as a life-saving treatment method,” says Andrey Bautin, the principal investigator and Head of Anesthesiology and Intensive Care Research Laboratory at Almazov Centre.
The device can be used in intensive care units, anesthesiology departments, cardiology centres, neonatal units and perinatal centres. It is protected by five Russian patents.