English
On-X
®
Prosthetic Heart Valve | Instructions for Use
4
orifice internal diameter (D)
orifice internal diameter (D)
tissue annulus (mounting) diameter (A)
external sewing ring diameter (S)
profile height open (H)
profile height closed (h)
orifice internal diameter (D)
tissue annulus (mounting) diameter (A)
external sewing ring diameter (S)
profile height open (H)
profile height closed (h)
orifice internal diameter (D)
external sewing ring diameter (S)
orifice internal diameter (D)
tissue annulus (mounting) diameter (A)
external sewing ring diameter (S)
tissue annulus (mounting) diameter (A)
external sewing ring diameter (S)
profile height open (H)
profile height closed (h)
tissue annulus (mounting) diameter (A)
profile height open (H)
profile height closed (h)
profile height open (H)
profile height closed (h)
INSTRUCTION FOR USE
CAUTION: Federal law (USA) restricts this device to
sale by or on the order of a physician.
1. DEVICE DESCRIPTION
The On-X
®
Prosthetic Heart Valve (Figure 1) is a bileaflet
mechanical heart valve, which consists of an orifice
housing and two leaflets. The orifice inflow area has a
flared inlet designed to reduce flow turbulence, and
the outflow rim consists of leaflet guards designed to
protect the leaflets while in the closed position. The
leaflets rotate around tabs located within the inner
circumference of the orifice ring. In the closed position,
each leaflet forms a nominal angle of 40º relative to the
plane of the orifice. In the open position, the plane of
each leaflet forms a nominal angle of 90º relative to the
plane of the orifice. The leaflets have a travel arc of 50º
to the closed position.
The orifice is composed of graphite substrate coated
with On-X
®
Carbon, a pure unalloyed form of pyrolytic
carbon. The leaflets consist of On-X
®
Carbon deposited
on a graphite substrate, which is impregnated with 10
weight% tungsten to provide radiopacity.
The sewing ring is constructed of
polytetrafluoroethylene (PTFE) fabric mounted on the
orifice using titanium retaining rings and 5-0 suture
material. This form of sewing ring attachment to the
orifice allows for rotation of the sewing ring in situ during
implantation. Orientation reference marks are provided
on the sewing ring for valve orientation.
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, 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.
2. INDICATIONS FOR USE
The On-X Prosthetic Heart Valve is indicated for the
replacement of diseased, damaged, or malfunctioning
native or prosthetic heart valves in the aortic and mitral
positions.
3. CONTRAINDICATIONS
The On-X Prosthetic Heart Valve is contraindicated for
patients unable to tolerate anticoagulation therapy.
Figure 1: Aortic and Mitral Profiles
(See Table 1 for corresponding dimensions)
(C) AORTIC ANATOMIC (ONXAN, ONXANE)
(B) AORTIC CONFORM-X
®
(ONXAC, ONXACE)
(A) AORTIC (ONXA, ONXAE)
(D) MITRAL (ONXM)
(E) MITRAL CONFORM-X
®
(ONXMC)
