HEMASHIELD tHorAcIc rAngE WoVEn StrAIgHt AnD BrAncH...

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HEMASHIELD THORACIC RANGE WOVEN STRAIGHT AND BRANCH GRAFTS

Transcript of HEMASHIELD tHorAcIc rAngE WoVEn StrAIgHt AnD BrAncH...

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HEMASHIELD tHorAcIc rAngE WoVEn StrAIgHt AnD BrAncH grAFtS

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HEMASHIELD tHorAcIc rAngEWoVEn DoUBLE VELoUr StrAIgHt AnD BrAncH grAFtSA grAFt DESIgnED For EAcH tEcHnIQUE

HEMASHIELD Four Branch Graft

HEMASHIELD Angled Four Branch Graft

HEMASHIELD Three Branch Graft

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 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 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

Provides flexibility to adapt to arch anomalies and complications during

surgery2

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HEMASHIELD tHorAcIc rAngEWoVEn DoUBLE VELoUr StrAIgHt AnD BrAncH grAFtStHE MoSt USED, MoSt StUDIED VAScULAr grAFtS

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 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 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 Straight Graft

HEMASHIELD One Branch Graft

HEMASHIELD Thoraco Abdominal Aortic Graft

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HEMASHIELD tHorAcIc rAngEWoVEn DoUBLE VELoUr StrAIgHt AnD BrAncH grAFtSMorE oPtIonS. IMProVED oUtcoMES.

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. Graft-related complications after abdominal aortic aneurysm repair: reassurance from a 36-year population-based experience. J Vasc Surg. 1997;25:277-286.

InStrUctIonS For USE

PrEScrIPtIVE InForMAtIon: Refer to the operator’s manual for complete instructions for use. 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 replace-ment.

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.

HEMASHIELD PLAtInUM grafts – the most used, most

studied vascular grafts. Whether the procedure requires

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

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

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HEMASHIELD tHorAcIc rAngE grAFt SoLUtIonSProDUct InForMAtIon

StrAIgHt tUBES

UPn order number Diameter (mm)

Usable Length (cm)

Over 15cm Usable Length

M00202175112P0 175112P 12 15M00202175114P0 175114P 14 15M00202175116P0 175116P 16 15M00202175118P0 175118P 18 15M00202175120P0 175120P 20 15M00202175122P0 175122P 22 15M00202175124P0 175124P 24 15M00202175126P0 175126P 26 15M00202175128P0 175128P 28 15M00202175130P0 175130P 30 15M00202175132P0 175132P 32 15M00202175134P0 175134P 34 15M00202175138P0 175138P 38 15

Over 30cm Usable Length

M00202175206P0 175206P 6 30M00202175207P0 175207P 7 30M00202175208P0 175208P 8 30M00202175210P0 175210P 10 30M00202175412P0 175412P 12 30M00202175414P0 175414P 14 30M00202175416P0 175416P 16 30M00202175418P0 175418P 18 30M00202175420P0 175420P 20 30M00202175422P0 175422P 22 30M00202175424P0 175424P 24 30M00202175426P0 175426P 26 30M00202175428P0 175428P 28 30M00202175430P0 175430P 30 30M00202175432P0 175432P 32 30M00202175434P0 175434P 34 30M00202175438P0 175438P 38 30

Over 40cm Usable Length

M00202175306P0 175306P 6 40M00202175307P0 175307P 7 40M00202175308P0 175308P 8 40M00202175310P0 175310P 10 40

Over 60cm Usable Length

M00202175406P0 175406P 6 60M00202175407P0 175407P 7 60M00202175408P0 175408P 8 60M00202175410P0 175410P 10 60M00202175620P0 175620P 20 60M00202175622P0 175622P 22 60M00202175624P0 175624P 24 60M00202175626P0 175626P 26 60M00202175628P0 175628P 28 60M00202175630P0 175630P 30 60M00202175632P0 175632P 32 60M00202175634P0 175634P 34 60M00202175638P0 175638P 38 60

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.

BIFUrcAtIonS

UPn order number Diameter (mm)

Usable Length (cm)

Over 40cm Usable Length

M00202166126P0 166126P 12 x 6 40M00202166147P0 166147P 14 x 7 40M00202166148P0 166148P 14 x 8 40M00202166168P0 166168P 16 x 8 40M00202166169P0 166169P 16 x 9 40M00202166189P0 166189P 18 x 9 40M00202166180P0 166180P 18 x 10 40M00202166201P0 166201P 20 x 10 40M00202166211P0 166211P 20 x 11 40M00202166221P0 166221P 22 x 11 40M00202166241P0 166241P 24 x 12 40

onE BrAncH grAFtS

UPn order number thoracic Size (mm x cm)

Branch Diameters (mm)

M00202175820P0 175820P 20 x 50 10M00202175822P0 175822P 22 x 50 10M00202175824P0 175824P 24 x 50 10M00202175826P0 175826P 26 x 50 10M00202175828P0 175828P 28 x 50 10M00202175830P0 175830P 30 x 50 10M00202175832P0 175832P 32 x 50 10M00202175834P0 175834P 34 x 50 10

tHrEE BrAncH grAFtS

UPn Diameter(mm)

Usable Length (cm)

Branch Diameters (mm)

M002021759120 12 30 8M002021759140 14 30 10

FoUr BrAncH grAFtS

UPn order number thoracic Size (mm x cm)

Branch Diameters (mm)

M00202175920P0 175920P 20 x 50 10, 10, 8, 8M00202175922P0 175922P 22 x 50 10, 10, 8, 8M00202175924P0 175924P 24 x 50 10, 10, 8, 8M00202175926P0 175926P 26 x 50 10, 10, 8, 8M00202175928P0 175928P 28 x 50 10, 10, 8, 8M00202175930P0 175930P 30 x 50 10, 10, 8, 8M00202175732P0 175732P 32 x 50 12, 10, 10, 10M00202175734P0 175734P 34 x 50 12, 10, 10, 10

Angled Four Branch Graft

M00202175724AP0 175724AP 24 x 50 12, 10, 8, 8M00202175726AP0 175726AP 26 x 50 12, 10, 8, 8M00202175728AP0 175728AP 28 x 50 12, 10, 8, 8M00202175730AP0 175730AP 30 x 50 12, 10, 8, 8

tHorAco ABDoMInAL AortIc grAFtS

UPn Diameter(mm)

thoracic Size (mm x cm)

Branch Diameters (mm)

M00202175426T0 175426T 26 x 47 10, 10, 8, 8M00202175428T0 175428T 28 x 47 10, 10, 8, 8M00202175430T0 175430T 30 x 47 10, 10, 8, 8M00202175432T0 175432T 32 x 47 10, 10, 8, 8

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HEMASHIELD tHorAcIc rAngEWoVEn DoUBLE VELoUr StrAIgHt AnD BrAncH grAFtSMAQUEt – tHE goLD StAnDArD

A comprehensive, proven vascular graft portfolio

and exceptional professional support make MAQUET

Cardiovascular a valuable asset to cardiac, thoracic and

vascular surgeons and their teams. Sealed with a patented

collagen impregnation process without using a cross-linking

agent, HEMASHIELD pre-sewn branch grafts provide clinical

benefits such as reduced procedure time and improved

cerebral protection and hemostasis. MAQUET offers a range

of convenient and innovative clinical solutions for thoracic

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 strives to be the first choice to surgeons

performing vascular repair procedures by providing

products designed to help improve the lives of patients

with specific vascular therapy needs. Trusted for over 20

years, MAQUET's HEMASHIELD Grafts are the most used,

most studied vascular products available in the market

today. More than 2 million HEMASHIELD grafts have been

implanted worldwide, demonstrating clinical efficacy and

improved patient outcomes.

MAQUET – The Gold Standard.

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MCV00003886

MAQUET GmbH & Co. KGKehler Straße 31D-76437 Rastatt, GermanyPhone: +49 (0) 7222 932-0Fax: +49 (0) 7222 932-571Service-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.

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

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