1. No category

knitted vascular products
hemagard
Atrium Medical Corporation
5 Wentworth Drive
Hudson, NH 03051
Phone: (+1)603-880-1433
Fax: (+1)603-880-6718
www.atriummed.com
ATRIUM HAS JOINED MAQUET GETINGE GROUP
| 2 | Knitted Vascular Products | Cardiovascular |
KNITTED VASCULAR PRODUCTS
HEMAGARD KNITTED
Material:
Healing:
C ollagen-coated polyester graft
Excellent graft healing and tissue incorporation
Reverse locknit knitting technique
K nitted construction designed to promote optimal healing
Water permeability : ≤ 5ml . cm -2 . min -1
and significantly reduce the potential for postoperative
1
dilatation
HEMAGARD Knitted properties:
S uperior proprietary textile design: reverse locknit knitting
Handling:
technique produces burst strength, radial tensile strength
Reverse locknit construction with excellent handling and
and suture pull-out strength characteristics which are
suturing characteristics
significantly greater than corresponding material, which
utilize a tricot knit 1
HEMAGARD locknit construction demonstrated long term
Hemostasis:
No suture hole bleeding
stability and resistance to post-operative dilatation
PHYSICAL AND MECHANICAL PROPERTIES*
Coated polyester fabric
Construction
Water permeabilit y
Wall thickness**
Burst strength**
45°suture retention**
Knitted
Cross-linked Type I bovine collagen
Knitted, reverse locknit
≤ 5ml • cm -2 • min -1@120 mmHg
0.49 mm
32.7 kg/cm 2
3.37 kg
* Testing performed per ANSI/AAMI ISO 7198:1998/2001.
** Test results are for customer evaluation only and do not represent a product
specification.
Reverse Locknit
Tricot Knit
(Collagen impregnated graft)
| Cardiovascular | Knitted Vascular Products | 3 |
KNITTED VASCULAR PRODUCTS
HEMAGARD KNITTED
A randomized clinical trial compared the dilatation charac-
knit construction. A significantly lower degree of dilatation
teristics of the INTERGARD* Knitted collagen coated graft,
was found for the reverse locknit construction compared to
which incorpates a reverse locknit construction, with both a
the warp/tricot knitted grafts. 2
collagen impregnated and uncoated graft with a warp/tricot
Mean Aortic Body Dilatation:
Femoral Level Mean Dilatation:
6.8% – INTERGARD* REVERSE
LOCKNIT POLYESTER
2.5% – INTERGARD* REVERSE
LOCKNIT POLYESTER
31.0% – TRICOT KNITTED POLYESTER
COLLAGEN IMPREGNATED
23.8% – TRICOT KNITTED POLYESTER
COLLAGEN IMPREGNATED
37.8% – TRICOT KNITTED POLYESTER
UNCOATED
0
10
20
30
40
50
60
70
80
90
100
31.7% – TRICOT KNITTED POLYESTER
UNCOATED
0
10
20
30
% dilatation
A clinical study to evaluate the performance of the
patency rate for the INTERGARD* knitted graft.3
* F ormally known as the established brand “INTERGARD”, this knitted
prosthesis is now rebranded as “HEMAGARD”.
1. Data on file, InterVascular
2. Swartbol P, Albrechtsson U, Parsson H, Norgren L. Dilatation of aortobifemoral
grafts after a mean implantation of 5 years. International Angiology 1996 Vol. 15
No. 3 pp. 236-239.
3. INTERGARD Collagen Coated Knitted Vascular Grafts: Results of the U.S. Clinical
Trial
60
70
80
90
100
summary of one-year results
marketed collagen impregnated control graft was conducted
demonstrated fewer complications and a higher primary
50
% dilatation
INTERGARD* knitted vascular graft versus a currently
at five investigational centers in the United States. The results
40
Acturial Survival Rate
Safet y
Mortality
Explant
Amputation
Wound/Graft Infection
Bleeding
Thrombosis/Occlusion
Embolism
Ef fectiveness
Primary Patency
INTERGARD*
N=311
89.5% (247)
Control
N=153
80.8% (73)
10.5%
2.3%
0.4%
3.4%
1.4%
8.4%
0.0%
19.2%
4.2%
1.4%
7.1%
3.2%
19.8%
2.1%
91.6%
80.0%
| 4 | Knitted Vascular Products | Cardiovascular |
KNITTED VASCULAR PRODUCTS
HEMAGARD KNITTED
Straight
20 cm length:
Diameter
6 mm
7 mm
8 mm
10 mm
12 mm
14 mm
18 mm
20 mm
22 mm
24 mm
40 cm length:
Reference
HGK0006-20
HGK0007-20
HGK0008-20
HGK0010-20
HGK0012-20
HGK0014-20
HGK0018-20
HGK0020-20
HGK0022-20
HGK0024-20
Diameter
6 mm
7 mm
8 mm
10 mm
12 mm
14 mm
16 mm
18 mm
20 mm
22 mm
24 mm
Reference
HGK0006-40
HGK0007-40
HGK0008-40
HGK0010-40
HGK0012-40
HGK0014-40
HGK0016-40
HGK0018-40
HGK0020-40
HGK0022-40
HGK0024-40
60 cm length:
Diameter
12 mm
8 mm
6 mm
8 mm
6 mm
8 mm
8 mm
Proximal/
Distal Length
40/15 cm
35/15 cm
35/15 cm
25/15 cm
25/15 cm
20/20 cm
Diameter
6 mm
7 mm
8 mm
10 mm
8x8 mm
10x10 mm
8x8 mm
8x8 mm
8x8 mm
10x8x8 mm
8x6x6 mm
Distal Length
body/branch
20/35 cm
20/25 cm
20/25 cm
25/35 cm
25/35 cm
Diameter
6 mm
7 mm
10 mm
Reference
HGK0006-70
HGK0007-70
HGK0008-70
HGK0010-70
Bifurcated
Supported
Length
15 cm
20 cm
20 cm
30 cm
30 cm
45 cm
Total
Length
70 cm
70 cm
70 cm
70 cm
70 cm
85 cm
Reference
Total
Length
body/branch
100/60 cm
100/60 cm
85/55 cm
85/55 cm
100/55 cm
85/55 cm
85/55 cm
Reference
HGK0008RS15
HGK0006RS20
HGK0008RS20
HGK0006RS30
HGK0008RS30
HGK0008RS45
AXILLO BIFEMORAL grafts
Diameter
Reference
HGK0012-60
70 cm length:
radially supported
Diameter
100 cm length:
Supported
Length
body/branch
45/20 cm
45/30 cm
60/30 cm
35/20 cm
35/20 cm
HGK A X0808
HGK A X1010
HGK A X0808RS45/20
HGK A X0808RS45/30
HGK A X0808RS60/30
HGKAX100808RS35/20
HGKAX080606RS35/20
50 cm length:
Diameter
12 mm x 6 mm
12 mm x 7 mm
14 mm x 7 mm
14 mm x 8 mm
16 mm x 8 mm
16 mm x 9 mm
18 mm x 9 mm
18 mm x 10 mm
20 mm x 10 mm
20 mm x 11 mm
22 mm x 11 mm
24 mm x 12 mm
Reference
HGK1206
HGK1207
HGK1407
HGK1408
HGK1608
HGK1609
HGK1809
HGK1810
HGK2010
HGK2011
HGK2211
HGK2412
Reference
HGK0006-100
HGK0007-100
HGK0010-100
| Cardiovascular | Knitted Vascular Products | 5 |
KNITTED VASCULAR PRODUCTS
HEMAGARD KNITTED ultrathin:
the ultimate small caliBER graft
Material:
Healing:
C ollagen-coated polyester graft
K nitted construction designed to promote optimal healing
T hinnest knitted polyester collagen-coated graft on the
Provide alternative for peripheral bypass procedures when
market
vein is not available 1, with comparable patency rates to
Reverse locknit knitting technique
other prosthetic materials
Water permeability : ≤ 5ml . cm -2 . min -1
E xcellent host vessel conformability
2
Wall thickness of 0.35mm
Handling:
HEMAGARD Knitted Ultrathin properties:
Proprietary Ultrathin wall technology designed to over-
Reverse locknit construction with excellent handling and
suturing characteristics
come complications such as hyperplasia, host vessels
T hinner and highly compliant graft due to its radial and
mismatch, and suture hole bleeding.
longitudinal pulsatility
Available in radially supported configuration for kink and
compression resistance.
Hemostasis:
No suture hole bleeding
PHYSICAL AND MECHANICAL PROPERTIES*
Coated polyester fabric
Construction
Water permeabilit y
Wall thickness**
Burst strength**
45°suture retention**
Ultrathin
Cross-linked Type I bovine collagen
Knitted, reverse locknit
≤ 5ml • cm -2 • min -1@120 mmHg
0.35 mm
35.3 kg/cm 2
1.83 kg
* Testing performed per ANSI/AAMI ISO 7198:1998/2001.
** Test results are for customer evaluation only and do not represent a product specification.
1. INTERGARD*** Collagen Coated Knitted Vascular Grafts:
Results of the U.S. Clinical Trial
2. Manougian S. Prosthetic below-knee femoropopliteal bypass
grafting. Late results with the INTERGARD Ultrathin vascular
prosthesis. Zentralbl Chir 2000; 125:280-285
*** F ormally known as the established brand “INTERGARD”,
this knitted prosthesis is now rebranded as “HEMAGARD”.
| 6 | Knitted Vascular Products | Cardiovascular |
KNITTED VASCULAR PRODUCTS
HEMAGARD KNITTED ultrathin graft
ULTRATHIN radially supported STRAIGHT
Diameter
6 mm
7 mm
8 mm
6 mm
7 mm
8 mm
Proximal /
Distal Length
35/15 cm
35/15 cm
35/15 cm
25/15 cm
25/15 cm
25/15 cm
Supported
Length
20 cm
20 cm
20 cm
30 cm
30 cm
30 cm
Total
Length
70 cm
70 cm
70 cm
70 cm
70 cm
70 cm
Reference
HGKUT0006RS20
HGKUT0007RS20
HGKUT0008RS20
HGKUT0006RS30
HGKUT0007RS30
HGKUT0008RS30
ULTRATHIN straight
40 cm length:
Diameter
6 mm
7 mm
8 mm
70 cm length:
Reference
HGKUT0006-40
HGKUT0007-40
HGKUT0008-40
Diameter
6 mm
7 mm
8 mm
Reference
HGKUT0006-70
HGKUT0007-70
HGKUT0008-70
| Cardiovascular | Knitted Vascular Products | 7 |
KNITTED VASCULAR PRODUCTS
HEMAGARD PATCH KNITTED
Material:
HEMAGARD PATCH properties:
C ollagen-coated polyester patch
S uperb handling and suturability
Reverse locknit knitting technique
Water permeability : ≤ 5ml . cm . min
-2
No suture hole bleeding
-1
PHYSICAL AND MECHANICAL PROPERTIES*
Coated polyester fabric
Construction
Water permeabilit y
Wall thickness**
HEMAGARD Patch Knitted
Cross-linked Type I bovine collagen
Knitted, reverse locknit
≤ 5ml • cm -2 • min -1@120 mmHg
0.65 mm
* Testing performed per ANSI/AAMI ISO 7198:1998/2001.
** Test results are for customer evaluation only and do not represent a
product specification.
Wide range of sizes
KNITTED
Dimensions
25 mm x 50 mm
25 mm x 75 mm
25 mm x 150 mm
25 mm x 100 mm
50 mm x 50 mm
50 mm x 75 mm
50 mm x 150 mm
75 mm x 75 mm
100 mm x 100 mm
Reference
HGK25/50P(1)
HGK25/75P(1)
HGK25/150P(1)
HGK25/100P(1)
HGK50/50P(1)
HGK50/75P(1)
HGK50/150P(1)
HGK75/75P(1)
HGK100/100P(1)
| 8 | Knitted Vascular Products | Cardiovascular |
KNITTED VASCULAR PRODUCTS
HEMAGARD CAROTID PATCH KNITTED
Material:
C ollagen-coated polyester patch
Reverse locknit knitting technique
Water permeability : ≤ 5ml . cm -2 . min -1
HEMAGARD CAROTID patch properties:
S uperb handling and suturability
N o suture hole bleeding
PHYSICAL AND MECHANICAL PROPERTIES*
Coated polyester fabric
Construction
Water permeabilit y
Wall thickness**
HEMAGARD CAROTID Patch Knitted
Cross-linked Type I bovine collagen
Knitted, reverse locknit
≤ 5ml • cm -2 • min -1@120 mmHg
0.65 mm
* Testing performed per ANSI/AAMI ISO 7198:1998/2001.
** Test results are for customer evaluation only and do not represent a product
specification.
KNITTED
Dimensions
6 mm x 75 mm
8 mm x 75 mm
10 mm x 75 mm
12 mm x 75 mm
14 mm x 75 mm
6 mm x 75 mm
8 mm x 75 mm
10 mm x 75 mm
12 mm x 75 mm
14 mm x 75 mm
Tapered
Yes
Yes
No
No
No
Yes
Yes
No
No
No
Reference
HGKTP06/75CP(1)
HGKTP08/75CP(1)
HGK10/75CP(1)
HGK12/75CP(1)
HGK14/75CP(1)
HGKTP06/75CP(10)
HGKTP08/75CP(10)
HGK10/75CP(10)
HGK12/75CP(10)
HGK14/75CPy(10)
Units Per Box
1 unit per box
1 unit per box
1 unit per box
1 unit per box
1 unit per box
10 units per box
10 units per box
10 units per box
10 units per box
10 units per box
| Cardiovascular | Knitted Vascular Products | 9 |
KNITTED VASCULAR PRODUCTS
HEMAGARD CAROTID PATCH KNITTED ULTRATHIN
Material:
C ollagen-coated polyester patch
Reverse locknit knitting technique
Water permeability : ≤ 5ml . cm -2 . min -1
Wall thickness of 0.41mm
HEMAGARD CAROTID PATCH properties:
Proprietary Ultrathin wall technology
D esigned to enhance patch performance
O ffers superb handling and conformability to host vessels
E xcellent healing with no suture hole bleeding
PHYSICAL AND MECHANICAL PROPERTIES*
Coated polyester fabric
Construction
Water permeabilit y
Wall thickness**
Burst strength**
HEMAGARD CAROTID Patch Ultrathin
Cross-linked Type I bovine collagen
Knitted, reverse locknit
≤ 5ml • cm -2 • min -1@120 mmHg
0.41 mm
35.3 kg/cm 2
* Testing performed per ANSI/AAMI ISO 7198:1998/2001.
** Test results are for customer evaluation only and do not represent a product
specification.
KNITTED ULTRATHIN
Dimensions
6 mm x 75 mm
8 mm x 75 mm
8 mm x 150 mm
10 mm x 75 mm
12 mm x 75 mm
14 mm x 75 mm
6 mm x 120 mm
8 mm x 120 mm
25 mm x 75 mm
25 mm x 150 mm
6 mm x 75 mm
8 mm x 75 mm
10 mm x 75 mm
12 mm x 75 mm
14 mm x 75 mm
Tapered
Yes
Yes
Yes
No
No
No
Yes
Yes
No
No
Yes
Yes
No
No
No
Reference
HGKTP06/75CPUT(1)
HGKTP08/75CPUT(1)
HGK TP08/150CPUT(1)
HGK10/75CPUT(1)
HGK12/75CPUT(1)
HGK14/75CPUT(1)
HGKTP06/120CPUT(1)
HGKTP08/120CPUT(1)
HGK25/75CPUT(1)
HGK25/150CPUT(1)
HGKTP06/75CPUT(10)
HGKTP08/75CPUT(10)
HGK10/75CPUT(10)
HGK12/75CPUT(10)
HGK14/75CPUT(10)
Units Per Box
1 unit per box
1 unit per box
1 unit per box
1 unit per box
1 unit per box
1 unit per box
1 unit per box
1 unit per box
1 unit per box
1 unit per box
10 units per box
10 units per box
10 units per box
10 units per box
10 units per box
NOTES
GETINGE GROUP is a leading global provider of products and
systems that contribute to quality enhancement and cost efficiency
within healthcare and life sciences. We operate under the three
brands of ArjoHuntleigh, GETINGE and MAQUET. ArjoHuntleigh
focuses on patient mobility and wound management solutions.
GETINGE provides solutions for infection control within healthcare
and contamination prevention within life sciences. MAQUET
specializes in solutions, therapies and products for surgical
interventions, interventional cardiology and intensive care.
0568 Rev A
MAQUET Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 www.maquet.com/vascular
Additional Contact Address Label Here
® MAQUET Registered Trademark of MAQUET GmbH & Co. KG · Copyright MAQUET Cardiovascular LLC or its affiliates. All rights reserved. 004/12.
Atrium Medical Corporation
5 Wentworth Drive
Hudson, NH 03051
Phone: (+1) 603-880-1433
Fax:
(+1) 603-880-6718
www.atriummed.com