FOR CHEMICAL STABILIZATION OF TISSUES

THE CARDIOSOL SOLUTION
THE CARDIOSOL SOLUTION
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The Cardiosol solution is a chemical reagent – a sterile solution of modified glutaraldehyde. Cardiosol is intended for surface chemical stabilization of soft collagen-containing connective tissues of humans or animals. The patented technology of modification of glutaraldehyde based on photo-and thermal polymerization allows to obtain a solution of the agent that prevents the adhesion and crystallization of insoluble calcium salts. This is an ideal solution for autopericardial treatment when performing valve cusp reconstruction using the Shigeyuki Ozaki technique. The result of processing the pericardium is the fixation of the material, which makes it more convenient to cut out the cusps (the biotissue does not slip, it is easy to model) and also significantly increases the strength characteristics of the biological tissue.

The study of the calcium-binding activity of biomaterials in the "in vitro" experiment showed a decrease in the calcium content by 44% in samples after treatment of biotissues in a solution of Cardiosol compared to a solution of unmodified (normal) glutaraldehyde.
Indications for use
  • Chemical stabilization of biological tissues (treatment of autopartage)
Recommendations for use
  1. A nurse with non-sterile hands should treat the vial with a disinfectant.
  2. Inspect the bottle and the cap of the bottle for the safety of the locking cone of the first opening. If the cone is not damaged, open it.
  3. Pre-mechanically fix the fragment of biological tissue, if this is required by the operation technique and put it in a sterile container.
  4. Unscrew the cap of the bottle and pour the Cardiosol solution into a sterile container with biotissue.
  5. Make sure that the solution completely covers the biotissue.
  6. Process the biotissue in the solution for at least 10 minutes, gently swaying the container with the solution.
  7. Pour into a sterile container 200-250 cm3 of a sterile 0.9% sodium chloride solution.
  8. Place the treated biotissue in a sterile container with 0.9% sodium chloride solution.
  9. Wash the biotissue from the solution for 10 minutes with intensive stirring with a change of 0.9% sodium chloride solution every 5 minutes.
Properties of the solution
After treatment with a solution, the biomaterial becomes convenient for cutting out the cusps (the biotissue does not slip, it is easy to model and cut out). In addition chemical stabilization significantly increases the strength properties of the fabric.
Delivery form
The solution is placed in a bottle, hermetically sealed with a lid with the control of the first opening. The solution in a capped bottle (1 pcs.) and instructions for use (1 pcs.) are placed in a cardboard box. Cardboard boxes must be placed in transport containers.
Storage conditions
Storage conditions of the solution in a sealed bottle, packed in protective and transport containers: in heated and ventilated warehouses, warehouses with air conditioning located in any macroclimatic areas at air temperatures from plus 5°C to plus 25°C; the value of relative humidity: upper — 80% at plus 25°C, average annual – 60% at plus 20°C; no solar radiation exposure.
Shelf Life
The guaranteed shelf life of the solution corresponds to the "good to" date indicated on the labels and is 1 year. After the expiration date the solution must be disposed of. The solution and its packaging are disposed of in accordance with the requirements of SanPiN 2.1.7.2790-10 as medical waste of class A.
Information for lawyers of healthcare institutions
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.