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On-X
®
Prosthetic Heart Valve | Instructions for Use
7
8.4 Accessories
The On-X Prosthetic Heart Valve is designed to be used
only with On-XLTI On-X instruments. The instruments,
supplied separately, are provided as a set, which
includes sizers, rotators, an instrument handle, and a
leaflet probe. The instruments are reusable.
CAUTION: Sizers and instrument handles have
metallic regions that are bendable. Repeated
bending of these metallic regions can lead to fatigue
and fracture. To avoid instrument fracture during
use, the stem should be inspected for surface
cracks before and after each time it is bent. If metal
fatigue surface cracks are present, the sizer and/
or instrument handle should be discarded and
replaced. Contact On-XLTI Customer Service to order
replacements.
CAUTION: Leaflet probes and rotators are flexible,
but are not intended to be bent to a permanently
deformed state.
Sizer
The sizer is used to gauge the resulting tissue annulus
diameter after the annulus is prepared for implant. The
sizer has a bendable stem on each end. The sizers are
cylindrical for size 19 mm through 25 mm valves and
conical for size 27/29 mm and 31/33 mm valves (Figure 3a
and 3b). To facilitate sizer selection, refer to Table 2.
Sizer Choice
Position of sewing ring
Size
Valve Type
Sizer Type
Use Replicate Sizer
19
Aortic
Cylindrical
YES
Intrasupra-annular
21
Aortic
Cylindrical
YES
Intrasupra-annular
23
Aortic
Cylindrical
YES
Intrasupra-annular
25
Aortic
Cylindrical
YES
Intrasupra-annular
27/29
Aortic
Conical
YES
Intra-annular
19*
Aortic Conform-X
Cylindrical
YES
Intrasupra-annular
21*
Aortic Conform-X
Cylindrical
YES
Intrasupra-annular
23*
Aortic Conform-X
Cylindrical
YES
Intrasupra-annular
25*
Aortic Conform-X
Cylindrical
YES
Intrasupra-annular
27/29*
Aortic Conform-X
Conical
YES
Intra-annular
19*
Aortic Anatomic
Cylindrical
YES
Intrasupra-annular
21*
Aortic Anatomic
Cylindrical
YES
Intrasupra-annular
23*
Aortic Anatomic
Cylindrical
YES
Intrasupra-annular
25*
Aortic Anatomic
Cylindrical
YES
Intrasupra-annular
27/29*
Aortic Anatomic
Conical
YES
Intra-annular
23*
Mitral
Cylindrical
NO
Supra-annular
25
Mitral
Cylindrical
NO
Supra-annular
27/29
Mitral
Conical
NO
Supra-annular
31/33
Mitral
Conical
NO
Supra-annular
25/33
Mitral Conform-X
Cylindrical or Conical
NO
Supra-annular
Replica Sizers
Aortic replica sizers are provided for all aortic valve
sizes (Figure 3a). They model the On-X standard aortic
valve profile. They are used after sizing for standard,
Conform-X, and Anatomic sewing ring configurations
to assure fit of the aortic valve without obstruction of
the coronary arteries. The size 19 through 25 aortic
replica sizers shape is intended to model intrasupra-
annular positioning. The size 27/29 aortic replica sizer is
intended to model intra-annular positioning.
Table 2: Sizer Selections - Regardless of Aortic Holder Type
Figure 3a: Sizer and Replica Sizer
Figure 3b: Sizer
Cylindrical
Aortic Replica
Conical
* Not available in all markets
