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 WOVEN DOUBLE VELOUR STRAIGHT AND BRANCH GRAFTS 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

HEMASHIELD thoracic range WOVEN DOUBLE VELOUR STRAIGHT AND BRANCH GRAFTS 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

Over 40cm Usable Length 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

Over 60cm Usable Length 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

Over 40cm Usable Length

Over 30cm Usable Length 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

HEMASHIELD thoracic range WOVEN DOUBLE VELOUR STRAIGHT AND BRANCH GRAFTS 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.



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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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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

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