HEMASHIELD tHorAcIc rAngE WoVEn StrAIgHt AnD BrAncH grAFtS

Transcription

HEMASHIELD THORACIC RANGE
WOVEN STRAIGHT AND BRANCH GRAFTS
HEMASHIELD THORACIC RANGE
WOVEN DOUBLE VELOUR STRAIGHT AND BRANCH GRAFTS
A graft designed for each technique
HEMASHIELD PLATINUM FOUR BRANCH GRAFT
Observed clinical advantages of the four branch arch graft replacement
include:
Dramatically reduced cerebral circulatory arrest times
(8.8 minutes compared to other similar procedures which
averaged 35 minutes)1,4-5
Significantly lowered risk of mortality and risk of neurologic dysfunction4
Negated the need for direct cannulation of brachiocephalic arteries, which
reduces the risk of embolization of air or atherosclerotic debris1,4
Provides an alternative technique to the Island Technique with retrograde
perfusion via femorals
HEMASHIELD Four Branch Graft
HEMASHIELD PLATINUM ANGLED FOUR BRANCH GRAFT
Observed clinical advantages of the angled four branch arch graft
replacement include:
Includes one branch for perfusion and three angled (60 degrees) branches
for repair or replacement of the head vessels
The head vessel branches mimic the natural anatomy of the head vessels
This angled version is an alternative to HEMASHIELD PLATINUM Four
Branch Graft
HEMASHIELD Angled Four Branch Graft
HEMASHIELD GOLD THREE BRANCH GRAFT
Observed clinical advantages aortic arch replacement using
Hypothermic Circulatory Arrest (HCA) with Selective Cerebral Perfusion
(SCP) using a 3 branch graft:
Clinical study showed superior results compared to HCA alone for
preventing embolic risk during operations on the aortic arch1
Reduced the amount of time and the associated complications of
cardiopulmonary bypass and/or selective cerebral perfusion1
Provided better clinical outcomes in clinical studies1 and is an alternative
to the Island Technique
Intended to provide superior operative support by allowing precise
construction of the Elephant Trunk anastomosis
HEMASHIELD Three Branch Graft
Provides flexibility to adapt to arch anomalies and complications during
surgery2
HEMASHIELD thoracic range
THE MOST USED, MOST STUDIED VASCULAR GRAFTS
HEMASHIELD PLATINUM THORACO ABDOMINAL AORTIC GRAFT
Designed for repair or replacement of the thoracic and abdominal portions
of the aorta
Branch grafts are pre-sewn and available for replacement of the right and
left renal arteries, as well as the SMA and celiac arteries
Reduces procedure time since branches are pre-sewn
HEMASHIELD Thoraco Abdominal Aortic Graft
HEMASHIELD PLATINUM STRAIGHT GRAFT
The straight and one branch grafts may be used for various procedures
including:
Ascending Thoracic Aortic Repair
Descending Thoracic Aortic Repair
Ascending and Innominate Repair (with single branch graft)
Island Technique for Arch Repair
HEMASHIELD Straight Graft
HEMASHIELD PLATINUM ONE BRANCH GRAFT
Clinical advantages of the one branch graft:
Designed to allow easier connection to the bypass
machine3
Helps to keep the bypass cannula out of the operating field3
May reduce time required for circulatory arrest since the graft is
preassembled
Helps preserve aortic graft integrity by providing cannula support for
bypass instead of puncturing the arch graft with the cannula
HEMASHIELD One Branch Graft
More options. Improved outcomes.
HEMASHIELD PLATINUM Grafts – the most used, most
INSTRUCTIONS FOR USE
studied vascular grafts. Whether the procedure requires
Prescriptive Information: Refer to the operator’s manual for complete
instructions for use.
a straight, one branch or multi-branch graft, HEMASHIELD
PLATINUM is the name that means history, hemostasis,
handling and healing.
Over 45 years textile graft technology experience
Over 8 million implanted textile grafts
Over 2 million HEMASHIELD implants
Clinical Benefits include:
Reduced procedure time1
Improved cerebral protection and hemostasis1-4
More technique options
Patient Benefits include:
Improved outcomes1-3
Significantly reduced complications1
Indications: All configurations of the HEMASHIELD PLATINUM Woven Double
Velour Vascular Graft are indicated for use in the replacement or repair of arteries
affected with aneurysmal or occlusive disease. The prosthesis is also recommended
for use in patients requiring systemic heparinization prior to, or during, surgery.
Contraindications: All configurations of the HEMASHIELD PLATINUM Woven
Double Velour Vascular Graft are not approved for use as a coronary artery replacement.
Warnings: DO NOT PRECLOT. With the treatment of HEMASHIELD PLATINUM
grafts, no preclotting is required. STERILE, DO NOT RESTERILIZE, SINGLE USE
ONLY. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft 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
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: Woven grafts should be cut with a low temperature, disposable cautery
(e.g., approximately 900 degrees F/approximately 500 degrees C) to prevent raveling.
The safety and effectiveness of this product in the extra-anatomic, A-V access and
pulmonary positions, and as a patch, have not been established.
Shortened intensive care and hospital stay1
Advanced Hemostasis:
Proprietary collagen impregnation reduces porosity to
improve hemostasis
Double-pass sewing technique provides improved
anastomotic seal
Advanced Handling5:
Soft, flexible woven material conforms to host vessel
for ease of anastomosis
Ease of suturing, smooth needle passage, snug
anastomosis
Advanced Healing:
Superb tissue ingrowth and long-term patency in
pre-clinical studies6
Excellent resorption rates facilitate superior,
uninterrupted healing6
Excellent long-term durability7
The information provided in this brochure is not intended to constitute medical advice.
Please reference entire paper for further information.
1. Strauch JT, Spielvogel D, Lauten A, Galla J, Lansman S, McMurtry K, Griepp
R. Technical advances in total aortic arch replacement. Ann Thorac Surg.
2004;77:581-590.
2. Spielvogel D, Etz CD, Silovitz D, Lansman SL, Griepp RB. Aortic arch replacement
with a trifurcated graft. Ann Thorac Surg. 2007; 83:S791-795.
3. Spielvogel D, Lansman SL, Griepp RB. Aortic Arch Replacement/Selective
Antegrade Perfusion. Operative Techniques in Thoracic and Cardiovascular Surgery:
A Comparative Atlas. 2005;10(1):23-44.
4. Kouchoukos NT, Masetti P. Total aortic arch replacement with a branched graft and
limited circulatory arrest of the brain. J Thorac Cardiovasc Surg. 2004;128:232-237.
5. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta
with collagen-impregnated woven Dacron grafts. J Thorac Cardiovasc Surg.
1993;106(3):427-433.
6. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. Comparative in vivo
study on the healing qualities of four different resealed vascular prostheses. J Vasc
Surg. 1993;17(3):538-545.
7. Hallett J, Marshall DM, Petterson TM, Gray DT, Bower TC, Cherry KJ, et al. Graftrelated complications after abdominal aortic aneurysm repair: reassurance from a
36-year population-based experience. J Vasc Surg. 1997;25:277-286.
HEMASHIELD thoracic range GRAFT SOLUTIONS
Product information
STRAIGHT TUBES
UPN
Order Number
BIFURCATIONS
Diameter
(mm)
Usable Length
(cm)
Over 15cm Usable Length
M00202175112P0
M00202175114P0
M00202175116P0
M00202175118P0
M00202175120P0
M00202175122P0
M00202175124P0
M00202175126P0
M00202175128P0
M00202175130P0
M00202175132P0
M00202175134P0
M00202175138P0
175112P
175114P
175116P
175118P
175120P
175122P
175124P
175126P
175128P
175130P
175132P
175134P
175138P
175206P
175207P
175208P
175210P
175412P
175414P
175416P
175418P
175420P
175422P
175424P
175426P
175428P
175430P
175432P
175434P
175438P
12
14
16
18
20
22
24
26
28
30
32
34
38
15
15
15
15
15
15
15
15
15
15
15
15
15
6
7
8
10
12
14
16
18
20
22
24
26
28
30
32
34
38
30
30
30
30
30
30
30
30
30
30
30
30
30
30
30
30
30
M00202175306P0
M00202175307P0
M00202175308P0
M00202175310P0
175306P
175307P
175308P
175310P
6
7
8
10
40
40
40
40
6
7
8
10
20
22
24
26
28
30
32
34
38
60
60
60
60
60
60
60
60
60
60
60
60
60
M00202175406P0
M00202175407P0
M00202175408P0
M00202175410P0
M00202175620P0
M00202175622P0
M00202175624P0
M00202175626P0
M00202175628P0
M00202175630P0
M00202175632P0
M00202175634P0
M00202175638P0
175406P
175407P
175408P
175410P
175620P
175622P
175624P
175626P
175628P
175630P
175632P
175634P
175638P
Order Number
Diameter
(mm)
Usable Length
(cm)
12
14
14
16
16
18
18
20
20
22
24
40
40
40
40
40
40
40
40
40
40
40
M00202175206P0
M00202175207P0
M00202175208P0
M00202175210P0
M00202175412P0
M00202175414P0
M00202175416P0
M00202175418P0
M00202175420P0
M00202175422P0
M00202175424P0
M00202175426P0
M00202175428P0
M00202175430P0
M00202175432P0
M00202175434P0
M00202175438P0
UPN
The C-code used for this product is C1768, Vascular grafts. C-codes are
used for hospital outpatient device reporting for Medicare and some private
payers. Medicare mandates certain C-code/CPT ® code combinations.
M00202166126P0
M00202166147P0
M00202166148P0
M00202166168P0
M00202166169P0
M00202166189P0
M00202166180P0
M00202166201P0
M00202166211P0
M00202166221P0
M00202166241P0
166126P
166147P
166148P
166168P
166169P
166189P
166180P
166201P
166211P
166221P
166241P
x
x
x
x
x
x
x
x
x
x
x
6
7
8
8
9
9
10
10
11
11
12
One Branch GraftS
UPN
Order Number
M00202175820P0
M00202175822P0
M00202175824P0
M00202175826P0
M00202175828P0
M00202175830P0
M00202175832P0
M00202175834P0
175820P
175822P
175824P
175826P
175828P
175830P
175832P
175834P
Thoracic Size
(mm x cm)
20 x 50
22 x 50
24 x 50
26 x 50
28 x 50
30 x 50
32 x 50
34 x 50
Branch
Diameters (mm)
10
10
10
10
10
10
10
10
Usable Length
(cm)
30
30
Branch
Diameters (mm)
8
10
Thoracic Size
(mm x cm)
20 x 50
22 x 50
24 x 50
26 x 50
28 x 50
30 x 50
32 x 50
34 x 50
Branch
Diameters (mm)
10, 10, 8, 8
10, 10, 8, 8
10, 10, 8, 8
10, 10, 8, 8
10, 10, 8, 8
10, 10, 8, 8
12, 10, 10, 10
12, 10, 10, 10
24
26
28
30
12,
12,
12,
12,
Three Branch GraftS
UPN
M002021759120
M002021759140
Diameter
(mm)
12
14
FOUR BRANCH GRAFTS
UPN
Order Number
M00202175920P0
M00202175922P0
M00202175924P0
M00202175926P0
M00202175928P0
M00202175930P0
M00202175732P0
M00202175734P0
175920P
175922P
175924P
175926P
175928P
175930P
175732P
175734P
Angled Four Branch Graft
M00202175724AP0
M00202175726AP0
M00202175728AP0
M00202175730AP0
175724AP
175726AP
175728AP
175730AP
x
x
x
x
50
50
50
50
10,
10,
10,
10,
8,
8,
8,
8,
8
8
8
8
THORACO ABDOMINAL AORTIC GraftS
UPN
M00202175426T0
M00202175428T0
M00202175430T0
M00202175432T0
Diameter
(mm)
175426T
175428T
175430T
175432T
Thoracic Size
(mm x cm)
26 x 47
28 x 47
30 x 47
32 x 47
Branch
Diameters (mm)
10, 10, 8, 8
10, 10, 8, 8
10, 10, 8, 8
10, 10, 8, 8
MAQUET – THE GOLD STANDARD
A comprehensive, proven vascular graft portfolio
MAQUET strives to be the first choice to surgeons
and exceptional professional support make MAQUET
performing vascular repair procedures by providing
Cardiovascular a valuable asset to cardiac, thoracic and
products designed to help improve the lives of patients
vascular surgeons and their teams. Sealed with a patented
with specific vascular therapy needs. Trusted for over 20
collagen impregnation process without using a cross-linking
years, MAQUET's HEMASHIELD Grafts are the most used,
agent, HEMASHIELD pre-sewn branch grafts provide clinical
most studied vascular products available in the market
benefits such as reduced procedure time and improved
today. More than 2 million HEMASHIELD grafts have been
cerebral protection and hemostasis. MAQUET offers a range
implanted worldwide, demonstrating clinical efficacy and
of convenient and innovative clinical solutions for thoracic
improved patient outcomes.
and abdominal aneurysms and peripheral vascular therapy
options that include a line of double velour straight and
branch grafts designed for a range of clinical applications.
MAQUET – The Gold Standard.
MCV Headquarters
MAQUET Cardiovascular LLC
45 Barbour Pond Drive
Wayne, NJ 07470
Phone: (+1)408-635-0700 or 888-880-2874
Fax:
(+1)408-635-0717 or 888-899-2874
Email: [email protected]
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. 08/10.
MAQUET GmbH & Co. KG
Kehler Straße 31
D-76437 Rastatt, Germany
Phone: +49(0)7222 932-0
Fax:
+49(0)7222 932-571
Service-Hotline: +49 (0) 7222 932-745
For local contact:
Please visit our website
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 and intensive care. MCV00003886
MCV00003886 RevA

HEMASHIELD tHorAcIc rAngE WoVEn StrAIgHt AnD BrAncH grAFtS

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