Design and manufacture of heart valve bioprostheses and vascular grafts

UniLine Aortic

Biological Heart Valve Prosthesis

Юнилайн аорт изометрия

         

 

Юнилайн аорт. вид спереди

         

Юнилайн аорт вид сверху

 

Offers ease of implantation and optimal hemodynamic performance.

It has been used in clinical practice since 2011.

Статьи значок

Articles

Значок видео Video
  • Overview
  • Product Specifications
  • Biological Tissue Treatment
  • Ordering Information

UniLine Aortic is a stented valve with bovine pericardium leaflets, designed for supra-annular implantation in the aortic position.

Design and Materials

Valve design features a compound stent, comprising polypropylene form and superelastic shape-memory wire. Valve stent biological tissue cover allows to perform special treatment of the entire surface.

To ensure ease of implantation valve's sewing ring partly determines the loop, which conforms to native aortic annulus.

Valve leaflets are made of bovine pericardium. Biological material is preserved, sterilized and cross-linked with ethylene glycol diglycidyl ether. Biological material fixed under technique used in NeoCor demonstrates resilience to calcium uptake and durability with regard to long-term clinical performance.

Preserved biolmaterial is further treated to promote valve's own antibacterial activity or enhanced resilience to calcification.

Leaflets Precision Manufacture

- High precision leaflet laser-cutting prevents any separation of collagen fibres along the edge;
- Leaflet fabrication computer technology featuring pericardium thickness detection prior to cutting provides consistent quality of each prothesis' leaflet apparatus. Maximum thickness homogeneity of the leaflet apparatus facilitates even stress distribution across the entire leaflet surface;

Final Quality Inspection 

- Each UniLine Valve is tested with hydrodynamic testing system to ensure compliance with requirements, specified in GOST 31618.1-2012 Cardiac valve prostheses. General technical requirements and test methods. Hydrodynamic parameters, i.e. EOA, transprosthetic gradient and regurgitation are recorded in order to give this data to the surgeon via an identification card each valve is supplied with.

 

For surgeons' convinience each prosthesis is supplied with a valve holder for implantation procedure.

Юнилайн с держателем

Valve size

Юнилайн Аорт. чертеж.eng

Bore Diameter (size), mm

External Diameter, mm

Aortic Protrusion, mm

Height, mm

21±1

23±1

10.5±1.5

14.5±1.5

23±1

22±1

11.5±1.5

15.5±1.5

25±1

27±1

12.5±1.5

16.5±1.5

 

UniLine bioprostheses performance specifications, obtained upon bench tests (manufacturer's data)

Parameter

Bore Diameter (size), mm

21

23

25

Flow Rate, cm3/cycle

90+3

96+6

108+10

Regurgitation, cm3/cycle

3.027+1.19

2.98+0.63

3.73+0.89

 

UniLine Aortic Bioprostheses' Hemodynamic performance based on prosthesis diameter

Parameter

Bore Diameter (размер), мм

21

23

25

    EOA (cm2),

   min-max

1.79+0.2

1.77-1.81

1.97+0.09

1.88-2.06

2.07±0.10

1.97-2.17

    Max ∆P, mm Hg,

     min-max

18.1+5.3

8-31

17.9+5.0

9-33

18.4±6.2

6-32

    Mean ∆Р, mm Hg,

    min-max

13.8+4.1

6-27

10.0+3.6

4.6-30

8.0±3.1

3.8-13

Note: EOA - effective orifice area, max ∆P - maximum aortic valve gradient, mean ∆P - mean aortic valve gradient; upper line reads mean values, lower line reads minimum and maximum values.

Anticalcification treatment. Standard treatment performed if no treatment method was specified in the order.
(Article: Use of aminodiphosphonates for prophylaxis of calcification of epoxy-treated bioprostheses)

Antithrombotic treatment. Performed if relevant treatment method was specified in the order.
- Antibacterial. Performed if relevant treatment method was specified in the order.
(Article: The new generation of heart valve bioprostheses with high thromboresistance and antibacterial activity)

By design each manufactured NeoCor bioprosthesis for cardiac surgery features anticalcification treatment for patients, whose bioprostheses are prone to calcification (treatment of congenital heart disease in children and acquired heart disease in adults under 50). Use of aminodiphosphonates leads to statistically significant calcium-binding activity decrease, whilst having no negative effect on biological material structure or physical and mechanical properties.

At surgeons' request bioprostheses are treated with heparin to reduce the risk of clot formation. When performing a procedure in the setting of infective endocarditis it is advisable to order and apply NeoCor bioprostheses featuring antibacterial treatment.

When placing an order, please specify if any additional bioprosthesis treatment is required.

To place an order, please submit your requisition via email neocor@neocor.ru or use the website contact form.

You may consult our Sales Department for NeoCor medical devices by phone 9 AM to 5 PM (Moscow time +4)

Valve Models:

Bore Diameter, mm (permissible deviation ±1.0) Reference No

21

ULA21b(s)

23

ULA23b(s)

25

ULA25b(s)

   When placing an order, please specify:

  Sewing Ring Type

  b - Biological

  s - Synthetic

   Treatment Method

 - Anticalcification (standard);

 - Antithrombotic;

 - Antibacterial.

The package consists of the following items:

   Description

Amount, pcs.

  UniLine Valve

1

  Implantation Holder

 (Handle and holder)

1

  Individual Package with Storage Solution

1

  Instructions for Use

1

  Identification Card

1