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. LT7900268
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