What is Cardiosol?
This is a chemical reagent — a sterile solution of modified glutaraldehyde. It is used for surface chemical stabilization of soft collagen-containing connective tissues (for example, for the treatment of autopericardium during the reconstruction of valve cusps using the Shigeyuki Ozaki method).
Cardiosol is a medical device?
No. According to article 38 p.1 and p.2 No. 323-FZ of the Federal law dated November 21, 2011 (ed. dated May 29, 2019) "On the basics of public health protection in the Russian Federation" Cardiosol does not fall under the definition of a medical device and cannot be classified as a medical device depending on the potential risk of use.
Is Cardiosol a drug?
No. According to article 4, p.1 No. 61-FZ of the Federal law dated April 12, 2010 (ed. dated August 2, 2019) "On the circulation of medicines" Cardiosol does not fall under the definition of a medicinal product (or pharmaceutical substance or medicinal product).
Is Cardiosol a chemical reagent?
Yes. This is a chemical reagent, which in its composition has: glutaric aldehyde, distilled water and HEPES (4-(2-hydroxyethyl)-1-piperazinethanesulfonic acid). The reagent is used in the production of medical devices based on biological materials in industrial conditions at manufacturing plants or in a clinic for the manufacture of a medical device (for example, an autoswitch for valve plastics) during surgery.
On the basis of what the clinic can buy the Cardiosol solution?
For example, for the treatment of autopericardium in the plastic of valve flaps according to the "Ozaki method" — based on the Resolution of the Government of the Russian Federation No. 1506 dated December 10, 2018 "On the program of state guarantees of free medical care to citizens for 2019 and for the planning period of 2020 and 2021" (Resolution). In the Annex of this document, there is a Section II with a list of types of high-tech medical care. The group 38 (page 185 of the Annex to the Resolution) includes the high-tech medical care under the following name: "Surgical treatment of congenital, rheumatic and non-rheumatic heart valve defects, heart tumors". The patient's model is "lesion of the valvular heart apparatus of various genesis". The method of treatment is "plastic valves in the conditions of artificial blood circulation". The average standard of financial costs per unit volume of this type of high-tech medical care includes the cost of purchasing reagents and chemicals.