On-X Ascending Aortic Prosthesis, Instructions For Use Manual

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On-X
®
Ascending Aortic Prosthesis IFU 4
English
Please note: All Figures and Tables are displayed in the last pages of
this booklet. Please refer to the final pages for illustrations and data.
1. DEVICE DESCRIPTION
Manufactured by On-X Life Technologies, Inc. TM (On-X LTI), the On-X ®
Ascending Aortic Prosthesis combines the On-X
®
Prosthetic Heart Valve
and the Gelweave Valsalva TM Vascular Prosthesis (Figure 1). The prosthesis
is available in sizes 19, 21, 23, 25, and 27/29 mm. The Gelweave Valsalva™
Vascular Prosthesis is incorporated into the cuff structure of the On-X valve
to create the ascending aortic prosthesis. Orientation reference marks are
provided on the exterior of the graft to aid implantation.
The On-X ® Prosthetic Heart Valve is a bileaflet mechanical heart valve,
which consists of an orifice and two leaflets. The orifice inflow area has a
flared inlet designed to reduce flow turbulence, and the outflow rim con-
sists of leaflet guards designed to protect the leaflets while in the closed
position. The leaflets rotate around tabs located within the inner circumfer-
ence 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 a graphite substrate coated with On-X
®
Carbon,
a pure unalloyed form of pyrolytic carbon. The leaflets consist of On-X ®
Carbon deposited on graphite substrates, which are impregnated with 10
weight% tungsten to provide radiopacity. The sewing cuff is constructed of
polytetrafluoroethylene (PTFE) fabric mounted on the orifice using titanium
retaining rings and 5-0 polyester suture material. This form of sewing cuff
attachment to the orifice allows for rotation of the sewing cuff in situ during
implantation.
The Gelweave Valsalva™ Vascular Prosthesis is a woven polyester prosthe-
sis designed to mimic the geometry of the sinus of Valsalva. The graft is
impregnated with an absorbable protein (modified mammalian gelatin) to
eliminate preclotting of the graft in surgery. The gelatin has been cross-
linked to a set level to control its rate of removal. After implant, the gelatin
is hydrolyzed within approximately 14 days and is replaced by normal tissue
incorporation. Gelatin is a non-antigenic and non-toxic protein as reflected
in its use as a safe plasma expander.
The gelatin used in the graft is manufactured from animals native to and
exclusively raised in Australia.
2. INDICATIONS
The On-X ® Ascending Aortic Prosthesis is indicated for the replacement of
a diseased, damaged, or malfunctioning native or prosthetic heart valve in
the aortic position in cases that involve an ascending aortic aneurysm or
other associated aortic disease.
3. CONTRAINDICATIONS
The On-X
®
Ascending Aortic Prosthesis is contraindicated for patients
unable to tolerate anticoagulation therapy or who exhibit sensitivity to
polyester or materials of bovine origin.