Valve-containing stents for the correction of heart defects

Specifications

The prosthesis is made of three wings and three fixing ears made of cattle pericardium, with a supporting metal frame (self-expanding nitinol stent), to correct defects of the aortic valve of the heart.

Due to its design features, the prosthesis provides the functional viability of the natural aortic valve of the heart, i.e. It has high reliability, cycle resistance and durability over the entire service life.

The main advantage of these prostheses is the “seamless” implantation technique, i.e. no need for suturing, which reduces the time of cardiopulmonary bypass and time of clamping of the aorta. The nitinol stent makes it easy to fold the structure and position the valve during implantation. Biological material is subjected to preliminary processing and subsequent preservation according to the original method using epoxy compounds (diepoxide).

The use of biological material from cattle provides a number of advantages compared with the bioprostheses made from pork aortic valve valves:

  • the pericardium contains less fluid (as a percentage of the mass) than the flaps of the porcine aortic valve, and therefore more structural material;
  • the pericardium contains 5 times more collagen fibers, which determines its greater strength,
  • the pericardium contains 3 times less phospholipids that contribute to calcification;
  • the structure of the valve flaps reproduces the tubular structure of the intrauterine development of the valve.

Description

Valve-containing stents for the correction of heart defects are designed to replace the aortic valve.

The valve-containing stent is supplied with a STERILE patented solution for transportation and storage. Re-sterilization of the prosthesis is prohibited.

Indications for use

The valve-containing stent is intended for use in patients in whom the aortic valve defect is expressed by a degree sufficient to justify the replacement of the native valve with a prosthesis. Typical cases of severe defect are aortic valve stenosis, aortic valve insufficiency, or a combination thereof.

Contraindications

Do not use a valve-containing stent for patients with active endocarditis. Do not use the single guiding suture technique in patients with a native bicuspid aortic valve, deformities, an aortic valve fibrous ring, or an irregular ascending aorta, which may or may not require aortic reconstruction.

Do not use a valve-containing stent unless the patient is clinically beneficial. Do not use a valve-containing stent to replace a pulmonary valve, tricuspid or mitral valve.

The use of this device is possible only by those doctors who participated in a special training on implantation of a valve-containing stent. Improper surgical implantation techniques can adversely affect this biological valve prosthesis. Physicians performing implantation should be familiar with methods for selecting patients, determining the condition of the ring, and measuring the valve.

Warnings

■ This device is intended for use only for one patient. It is forbidden to reuse, process or sterilize this product. Reuse, handling, or sterilization may compromise the structural integrity of the device and / or create a risk of contamination, which may result in injury, illness, or death to the patient.

■ The valve-containing stent and solution for transporting storage are supplied STERILE. VALVE DOES NOT BE SUBJECT TO RE-STERILIZATION BY ANY METHOD. Exposure to a biological prosthesis and container of exposure, steam, ethylene oxide or other chemical sterilizing agents makes the biological prosthesis completely unusable.

■ During the folding of the valve-containing stent, it MUST be immersed in a bath with cooled saline (freeze). The valve-containing stent can be folded immediately after immersion. Exposure to excessive load and tension on the nitinol framework may increase the risk of rupture of the framework.