LeMaitre XenoSure Mode D'emploi page 5

0.6BV8
0.8BV8
1BV6
1BV10
1.5BV10
1BV14
2BV9
4BV4
4BV6
6BV8
8BV14
10BV16
Alternate Patch Size Rinse Procedure
For any patch size not listed in the table, use the following rinse instruc-
tions.
Patch length (cm) x Patch width (cm) = Patch area (cm
If the patch has an area less than or equal to 24cm
rinse time of 2 minutes in 500ml of saline.
If the patch has an area greater than 24cm
160cm , the patch requires a rinse time of 3 minutes in 1000ml of saline.
2
Note: The patch area is based on one side of the patch. This calculation has
been formulated intentionally. Please follow the instructions.
Implantation
Cut and/or trim the XenoSure Biologic Patch to the desired shape. Any
excess XenoSure Biologic Patch material should be treated as biological
waste and discarded according to hospital procedure.
During implantation, irrigate the XenoSure Biologic Patch tissue frequently
with sterile physiologic saline to prevent drying.
Surgical Technique
It is beyond the scope of this Instructions for Use booklet to instruct the
surgeon in specific repair procedures. LeMaitre Vascular, Inc. assumes that
any surgeon performing the above operations has received adequate train-
ing and is thoroughly familiar with the pertinent scientific literature.
Clinical Experience
Bovine pericardial patches have been successfully used in intracardiac repair
procedures for the past 25 years with excellent clinical results. Published
data on such use may be found in medical literature.
At this time, the long term durability of fixed bovine pericardial tissue is
unknown. The clinical advantages in using this material along with its
known characteristics must be weighed against its current undetermined
long-term durability.
Limited Product Warranty; Limitation of Remedies
LeMaitre Vascular, Inc. warrants that reasonable care has been used in the
manufacture of this device. Except as explicitly provided herein, LEMAITRE
VASCULAR (AS USED IN THIS SECTION, SUCH TERM INCLUDES LEMAITRE
VASCULAR, INC., ITS AFFILIATES, AND THEIR RESPECTIVE EMPLOYEES,
OFFICERS, DIRECTORS, MANAGERS, AND AGENTS) MAKES NO EXPRESS OR
IMPLIED WARRANTIES WITH RESPECT TO THIS DEVICE, WHETHER ARISING BY
OPERATION OF LAW OR OTHERWISE (INCLUDING, WITHOUT LIMITATION, ANY
Model
e0.6BV8
e0.8BV8
e1BV6
e1BV10
e1.5BV10
e1BV14
e2BV9
e4BV4
e4BV6
e6BV8
e8BV14
e10BV16
Size (cm)
0.6x8
0.8x8
1x6
1x10
1.5x10
1x14
2x9
4x4
4x6
6x8
8x14
10x16
2
and less than or equal to
2
Rinse Procedure
500ml for 2
minutes
1000ml for 3
minutes
)
2
, the patch requires a