English
On-X
®
Prosthetic Heart Valve | Instructions for Use
6
8. HOW SUPPLIED
8.1 Available Models and Sizes
The On-X Prosthetic Heart Valve is available in 3 aortic
and 2 mitral sewing ring configurations. All aortic
configurations are available in sizes 19, 21, 23, 25, and
27/29 mm. The standard mitral sewing ring is available
in sizes 23, 25, 27/29 and 31/33 mm, while the Mitral
Conform-X sewing ring is available in size 25/33 only.
Aortic valves, size 19 mm through 25 mm, are designed
for intrasupra-annular sewing ring position, while the
valve size 27/29 mm is designed for intra-annular sewing
ring position. All mitral valve sizes are designed for the
supra-annular sewing ring position.
Aortic valves are available with either standard or
extended valve holders (Figure 2).
The dimensional and model specifications for all
available sizes of the On-X Prosthetic Heart Valve are
shown in Table 1 and Figure 1. The symbol SZ mm on
the box, container labels, and implant registration card
refers to the tissue annulus diameter of the valve in
millimeters.
8.2 Packaging
The On-X Prosthetic Heart Valve is provided sterile,
mounted on a holder, in a double-sealed plastic
container. The package consists of the following items:
• Outer box
• Patient record card
• Plastic valve container
• Implant registration card
• Plastic valve holder
• Valve serial number tag
• Instructions for use
Instruments for implantation of the On-X Prosthetic
Heart Valve are supplied separately,
NON-STERILE
, and
must be cleaned and sterilized prior to use as outlined in
section 8.5.
8.3 Storage
The On-X Prosthetic Heart Valve has been qualified
for a maximum storage life of 5 years from the date of
manufacture for the twist-off lid design, or 6 years for
the peel-off lid design. The sterility expiration date of
the On-X Prosthetic Heart Valve is recorded on the outer
package label. Appropriate inventory control should be
maintained so that prostheses with earlier expiration
dates are preferentially implanted and expiration is
avoided. To protect the valve, it should be stored in its
outer box until used. The storage environment should
be clean, cool, and dry.
Figure 2: Standard or Extended Aortic Valve Holders
Extended Holder
Standard Holder
Model Designator
Size/Type
Tissue Annulus
(mounting)
Diameter
(A)
Orifice Internal
Diameter
(D)
External
Sewing Ring
Diameter
(S)
Profile Height
(closed)
(h)
Profile Height
(open)
(H)
Internal Orifice
Area
(mm²)
Extended Holder
Standard Holder
ONXAE-19*
ONXA-19
19 Aortic
19
17.4
23
10.8
13.3
228
ONXAE-21*
ONXA-21
21 Aortic
21
19.4
26
11.9
14.7
284
ONXAE-23*
ONXA-23
23 Aortic
23
21.4
29
13.1
16.1
344
ONXAE-25*
ONXA-25
25 Aortic
25
23.4
32
14.2
17.8
411
ONXAE-27/29*
ONXA-27/29
27/29 Aortic
27-29
23.4
34
14.2
17.8
411
ONXACE-19*
ONXAC-19*
19 Aortic Conform-X
19
17.4
27
10.8
13.3
228
ONXACE-21*
ONXAC-21*
21 Aortic Conform-X
21
19.4
30
11.9
14.7
284
ONXACE-23*
ONXAC-23*
23 Aortic Conform-X
23
21.4
33
13.1
16.1
344
ONXACE-25*
ONXAC-25*
25 Aortic Conform-X
25
23.4
34
14.2
17.8
411
ONXACE-27/29*
ONXAC-27/29*
27/29 Aortic Conform-X
27-29
23.4
36
14.2
17.8
411
ONXANE-19*
ONXAN-19*
19 Aortic Anatomic
19
17.4
27
10.8
13.3
228
ONXANE-21*
ONXAN-21*
21 Aortic Anatomic
21
19.4
30
11.9
14.7
284
ONXANE-23*
ONXAN-23*
23 Aortic Anatomic
23
21.4
33
13.1
16.1
344
ONXANE-25*
ONXAN-25*
25 Aortic Anatomic
25
23.4
34
14.2
17.8
411
ONXANE-27/29*
ONXAN-27/29*
27/29 Aortic Anatomic
27/29
23.4
36
14.2
17.8
411
ONXM-23**
23 Mitral
23
21.4
31
13.1
16.1
344
ONXM-25
25 Mitral
25
23.4
33
14.2
17.8
411
ONXM-27/29
27/29 Mitral
27-29
23.4
34
14.2
17.8
411
ONXM-31/33
31/33 Mitral
31-33
23.4
36
14.2
17.8
411
ONXMC-25/33
Mitral Conform-X
25-33
23.4
39
14.2
17.8
411
Table 1: On-X Valve Specifications (millimeters)
* Not available in all markets
** Not available in the USA
Refer to Figure 1 for location of measured dimensions. Values given are nominal within the tolerance band.
