HEMASHIELD GOLD KNITTED VAScuLAr GrAfTS

HEMASHIELD GOLD
KNITTED VASCULAR GRAFTS
HEMASHIELD GOLD
KNITTED straight and bifurcated VASCULAR GRAFTS
Experience makes the difference
Experience Superb Healing:
„ „ Designed to provide initial blood-tight seal for improved
hemostasis5
„ „ Promotes formation of a smooth, thin pseudointima1
„ „ Enhances graft patency1
„ „ Provides controlled resorption for uniform tissue ingrowth1
Advancing Graft Technology:
„ „ First machine-made vascular graft
„„ First warp knitted graft to resist unraveling
„„ First bifurcated graft with anatomically correct limbs
„„ First crimped graft to resist kinking when pressurized
MAQUET Cardiovascular utilizes an exclusive patented
collagen impregnation process without using a crosslinking agent.
„„ First double velour graft for improved sealing, handling,
and healing
„„ First knitted, collagen impregnated zero pre-clot graft
Experience Exceptional Handling. HEMASHIELD Gold
grafts have improved handling characteristics without
compromising graft performance.**
„ „ Soft, flexible material is designed to conform to host
vessel for easier anastomosis
„ „ Smooth needle passage and excellent suture retention
are designed to reduce bleeding at the anastomosis
„ „ Highly compliant material promotes a snug fit at the
Double velour enhances graft incorporation to the vessel
wall and helps to improve pseudointimal formation.
anastomosis
HEMASHIELD Gold Grafts – Experience the Difference:
„ „ Over 20 years of experience
„ „ Over 8 million implanted textile grafts
„ „ Over 2 million HEMASHIELD implants
Caution: Federal (US) law restricts this device to sale by or on the order of a
physician.
Knitted material allows smooth needle passage and ease
of suturing creating a snug anastomosis
HEMASHIELD GOLD
KNITTED straight and bifurcated VASCULAR GRAFTS
the most trusted vascular grafts
Excellent Tissue Ingrowth
Highest Patency
100
Lumen Diameters
90
Gelatin A
Gelatin B
At placement
8mm
8mm
8mm
7.12mm
5.44mm
5.22mm
Gelatin A
80
% Tissue Ingrowth at 6 Weeks
Hemashield Collagen
6-months
post-placement
Hemashield Collagen
Gelatin B
70
60
50
40
30
20
10
0
HEMASHIELD Gold grafts have been shown to provide more complete tissue
ingrowth compared to competitive grafts1
HEMASHIELD Gold grafts have been shown to preserve a significantly larger
lumen diameter
Excellent Biocompatibility
HEMASHIELD Gold: Proven Efficacy
„„ “…proven record of safety and remarkable durability in the
12,000
Hemashield Collagen
LEUKOCYTE COUNT
Gelatin B
aortic position for AAA repair."3
„„ Recommended as “the prosthetic conduit of choice for
above-knee popliteal bypass.”4
10,000
8,000
6,000
Preoperative
Day 1
Postoperative
Day 7
Day 14
Day 21
HEMASHIELD Gold grafts have been shown to provide an earlier return to normal leukocyte levels compared to competitive grafts2
HEMASHIELD GOLD GRAFT SOLUTIONS
Product information
BIFURCATIONS
STRAIGHT TUBES
UPN
Order Number
M002020851260
M002020851270
M002020851470
M002020851480
M002020851680
M002020851690
M002020851890
M002020851800
M002020852010
M002020852110
M002020852210
M002020852410
085126
085127
085147
085148
085168
085169
085189
085180
085201
085211
085221
085241
Diameter
(mm x mm)
12 x 6
12 x 7
14 x 7
14 x 8
16 x 8
16 x 9
18 x 9
18 x 10
20 x 10
20 x 11
22 x 11
24 x 12
Usable Length
(cm)
40
40
40
40
40
40
40
40
40
40
40
40
AXILLO-BIFEMORAL
UPN
Order Number
095588
095589
095500
095501
Order Number
Diameter
(mm)
Usable Length
(cm)
6
7
8
10
12
14
16
18
20
22
24
15
15
15
15
15
15
15
15
15
15
15
6
7
8
10
12
14
16
18
20
22
24
30
30
30
30
30
30
30
30
30
30
30
6
7
8
40
40
40
6
7
8
10
12
60
60
60
60
60
6
7
8
10
100
100
100
100
Over 15cm Usable Length
M002020951060
M002020951070
M002020951080
M002020951100
M002020951120
M002020951140
M002020951160
M002020951180
M002020951200
M002020951220
M002020951240
095106
095107
095108
095110
095112
095114
095116
095118
095120
095122
095124
Over 30cm Usable Length
Diameter
(mm)
Side Branch
Over 100cm Length with 60cm Side Branch†
M002020955880
M002020955890
M002020955000
M002020955010
UPN
8
8
10
10
Right
Left
Right
Left
† Usable Length: 100cm, Side Branch Usable Length: 60cm
* Data on file, MAQUET Cardiovascular.
** Improved from previous HEMASHIELD product
M002020954060
M002020954070
M002020954080
M002020954100
M002020954120
M002020952140
M002020952160
M002020952180
M002020952200
M002020952220
M002020952240
095406
095407
095408
095410
095412
095214
095216
095218
095220
095222
095224
Over 40cm Usable Length
Specifications for all HEMASHIELD Gold Microvel Knitted Double Velour
Vascular Grafts: Porosity = <10 mL/min/cm 2
MAQUET Cardiovascular also makes available all these grafts in a woven
material. Refer to the HEMASHIELD Platinum™ product line.
M002020953060
M002020953070
M002020953080
095306
095307
095308
Over 60cm Usable Length
INSTRUCTIONS FOR USE
Prescriptive Information: Refer to the operator’s manual for
complete instructions for use.
Indications: All configurations of the HEMASHIELD Gold Microvel
Knitted Double Velour Vascular Graft are indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Contraindications: All configurations of the HEMASHIELD Gold
Microvel Knitted Double Velour Vascular Graft are not approved for use as
a coronary artery replacement.
Warnings: DO NOT PRECLOT. With the treatment of HEMASHIELD
Gold grafts, no preclotting is required. STERILE, DO NOT RESTERILIZE,
SINGLE USE ONLY.
The HEMASHIELD Gold Microvel Knitted Double Velour Vascular Grafts
cannot be resterilized. This graft should not be implanted in patients with
a known sensitivity to products of bovine origin.
Potential Adverse Effects: Bleeding, thrombosis, embolism, graft
infection, aneurysm, and pseudoaneursym even with the proper use of
medical devices. Accordingly, this device should only be used by persons
qualified in the procedures for which it is indicated.
Cautions: The safety and effectiveness of this product in the extraanatomic, a-v access and pulmonary positions, and as a patch, have not
be established.
M002020952060
M002020952070
M002020952080
M002020952100
M002020952120
095206
095207
095208
095210
095212
Over 100cm Usable Length
M002020955060
M002020955070
M002020955080
M002020955100
095506
095507
095508
095510
The information provided in this brochure is not intended to constitute
medical advice. Please reference entire paper for further information.
1. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. Comparative in vivo
study on the healing qualities of four different presealed vascular prostheses. J Vasc
Surg. 1993;17:538-45.
2. Utoh J, Goto H, Hirata T, Hara M, Kitamura N. Postoperative inflammatory
reactions to sealed Dacron prostheses: A comparison of Gelseal and
HEMASHIELD ® . J Cardiovasc Surg. 1997;38:287-90.
3. Hallett J, Marshall DM, Petterson TM, Gray DT, Bower TC, Cherry KJ, Gloviczki
P, Pairolero PC. Graft-related complications after abdominal aortic aneurysm
repair: Reassurance from a 36 year population-based experience. J Vasc Surg.
1997;25:277-86.
4. Abbott WM, Vignati JJ. Prosthetic Grafts: When are they a reasonable alternative?
Seminars in Vasc Surg. 1995;8:236-245.
5. Freischlag JA, Moore WS. Clinical Experience with a Collagen-Impregnated Knitted
Dacron Vascular Graft. Ann Vasc Surg. 1990;4:449-454.
HEMASHIELD GOLD
KNITTED straight and bifurcated VASCULAR GRAFTS
MAQUET – THE GOLD STANDARD
The MAQUET group is the global market leader for
improve the lives of patients with specific vascular therapy
Medical Systems, focusing on the Operating Room (OR)
needs. MAQUET graft solutions are designed for optimal
and Intensive Care Unit (ICU). The integrated products of
patient outcomes and feature technologies to improve
MAQUET are specially designed to deliver the best
hemostasis, encourage tissue in-growth, promote natural
medical treatment within acute care hospitals. With 170
healing and provide long-term durability. Trusted for over 20
years of experience, MAQUET strives to be the gold
years, HEMASHIELD Grafts are the most used, most studied
standard in devices, disposables, and surgical workplaces
vascular products available in the market today. More than 2
for customers around the globe.
million HEMASHIELD grafts have been implanted worldwide,
With a comprehensive, proven portfolio of vascular surgery
demonstrating clinical efficacy and improved outcomes.
implant solutions, MAQUET is a market leader in vascular
grafts. MAQUET offers a full range of market leading
treatment options to help cardiac and thoracic surgeons
MAQUET – The Gold Standard.
® MAQUET Registered Trademark of MAQUET GmbH & Co. KG · Copyright MAQUET Cardiovascular LLC or its affiliates. All rights reserved. 10/11.
MAQUET Cardiovascular LLC
170 Baytech Drive
San Jose, CA 95134
Phone: +1 (408) 635-6800
Toll-free: +1 (888) 880-2874
Fax:
+1 (888) 899-2874
www.maquet.com
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.
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