OVER 45 YEARS TEXTILE GRAFT TECHNOLOGY EXPERIENCE MAQUET THE GOLD STANDARD

Transcription

1 OVER 45 YEARS TEXTILE GRAFT TECHNOLOGY EXPERIENCE MAQUET 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. The HEMASHIELD Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch is used for cardiac and vascular patch grafting. MAQUET offers convenient and innovative clinical solutions for cardiothoracic and abdominal aneurysms and peripheral vascular therapy options including a line of surgical fabrics, meshes and tapes designed for a range of different 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.

2 MAQUET Registered Trademark of MAQUET GmbH & Co. KG Copyright MAQUET Cardiovascular LLC or its affiliates. All rights reserved. 08/08. MAQUET Cardiovascular LLC 170 Baytech Drive San Jose, CA Phone: Fax: Getinge Group is a leading global provider of equipment and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. Equipment, service and technologies are supplied under the brands ArjoHuntleigh for patient handling and hygiene, disinfection, DVT prevention, medical beds, therapeutic surfaces and diagnostics, GETINGE for infection cotrol and prevention within healthcare and life science and MAQUET for Surgical Workplaces, Cardiovascular and Critical Care. LT

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4 EXPERIENCE MAKES A MATERIAL DIFFERENCE Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch Sealed to a Higher Standard. The Hemashield Platinum Finesse Patch promotes exceptional handling, hemostasis and healing during vascular or cardiac patching procedures. The Hemashield Patch is the most used fabric for carotid endarterectomy, providing reliable and safe performance. Proprietary Hemashield collagen impregnation: Provides an initial blood-tight seal, improved tissue ingrowth and excellent biocompatibility Delivers advanced hemostasis with low porosity (<5 ml/cm 2 /min)* Ultra-thin knitted fabric: Handles like a vein Provides excellent conformability to host vessel Facilitates easy suturing and smooth needle passage Tapered, pre-trimmed design: Minimizes trimming Improves procedural efficiency Proven safety: In a randomized trial with 195 patients, 30-day follow-up demonstrated similar clinical results to autogenous saphenous vein when used for carotid endarterectomy 1 Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch Hemashield Double Velour Fabric Proprietary Hemashield collagen impregnation: Designed to provide an initial blood-tight seal and enhance tissue ingrowth Exclusive double velour material offers exceptional handling and strength Choice of knitted or woven fabric construction provides an excellent match to the clinical demands of abdominal, peripheral and thoracic applications Hemashield Double Velour Fabric Trelex Natural Meshes Polyester Tape (Umbilical Tape) A unique knitted polypropylene mesh. These meshes offer the strength to provide excellent reinforcement of soft tissue and improved handling characteristics. Strong, tight braided. The polyester tape reduces risk of tissue trauma while promoting effective retraction.

5 INstructions for Use Hemashield Platinum Finesse ULTRA-THIN KNITTED CARDIOVASCULAR PATCH, HEMASHIELD double velour Fabrics Indications: HEMASHIELD Knitted Double Velour Fabric, HEMASHIELD Woven Double Velour Fabric and HEMASHIELD PLATINUM FINESSE Ultra- Thin, Knitted Cardiovascular Patch are indicated for cardiac and vascular patch grafting. The fabrics are also recommended for use in patients requiring systemic heparinization prior to, or during, surgery. The GUIDELINE stripe on the HEMASHIELD Knitted Double Velour Fabric and the HEMASHIELD PLATINUM FINESSE Ultra-Thin, Knitted Cardiovascular Patch indicates the direction of greatest tensile strength; the HEMASHIELD Woven Double Velour Fabric is equally strong in both directions. Contraindications: This prosthesis is not indicated for use in reconstruction of hernias or tissue deficiencies, or reconstruction or repair of passive biological membranes (such as dura mater, pericardium, or peritoneum) Warnings: 1. DO NOT PRECLOT. With HEMASHIELD fabrics, no preclotting is required. 2. STERILE DO NOT RESTERILIZE SINGLE USE ONLY. HEMASHIELD fabrics cannot be resterilized. 3. These fabrics should not be implanted in patients with a known sensitivity to products of bovine origin. Precautions: 1. If surgical technique requires use of instruments with the fabric, use atraumatic instruments. 2. It is suggested that only taper-point needles be used for suturing. Taper cut or other cutting needles may cut the graft fibers. 3. Avoid excessive tension on the fabric. 4. Cutting to proper size is essential. Use sharp surgical scissors to trim the HEMASHIELD Knitted Double Velour Fabric and the HEMASHIELD PLATINUM FINESSE Ultra-Thin, Knitted Cardiovascular Patch. 5. The HEMASHIELD Woven Double Velour fabric should be cut with a low temperature, disposable cautery (e.g., 900 F/ 500 C) to prevent raveling. Cardiovascular velour, knitted, woven Fabrics Indications: Velour Fabrics - For arterial and ventricular septal defects, patch grafting and patch repair of carotid endarterectomy. Knitted Fabrics - For arterial and ventricular septal defects, patch grafting. Woven Fabric - Outflow tract patch, thoracic aortoplasty, or whenever blood loss is a concern. TRELEX NATURAL Meshes Indications: TRELEX NATURAL Meshes are indicated to reinforce soft tissue where weakness exists, e.g. for repair of hernia and chest wall defects. Contraindications: None known. Warnings: 1. Fabrics contaminated with human body fluid from previous surgery should not be used. 2. Destroy any portion of a fabric which has been contaminated by body fluid. Do not attempt to wash and resterilize a contaminated fabric. Precautions: 1. Trim TRELEX NATURAL Meshes to the desired size using sharp sterile surgical scissors. 2. If sutures are used to secure the mesh in place, nonabsorbable, monofilament sutures are recommended. As with any textile construction, it is suggested that only taper point needles be used. The use of taper cut or other cutting needles may damage the textile fibers. 3. SINGLE USE ONLY. polyester tape (umbilical tape) Indications: Retraction of blood vessels, nerves, organs and ligaments. Contraindications: None known. Warnings: 1. SINGLE USE ONLY. 2. Fabrics contaminated with human body fluid from previous surgery should not be used. Destroy any portion of a fabric which has been contaminated by body fluid. Do not attempt to wash and resterilize a contaminated fabric. PRECAUTIONS: 1. It is suggested that only taper point needles be used for suturing, as taper cut or other cutting needles may cut the fabric fibers. To place an order, contact customer service at Contraindications: None known. Warnings: 1. SINGLE USE ONLY. 2. Fabrics contaminated with blood or bodily fluids from previous surgery cannot be reused or resterilized. Destroy any portion of a fabric which has been contaminated by blood or bodily fluids. Do not attempt to wash and resterilize a contaminated fabric. 3. All non-sealed Cardiovascular Fabrics, woven as well as knitted, must be preclotted or sealed to reduce their permeability to blood. Precautions: 1. It is suggested that only taper point needles be used for suturing, as taper cut or other cutting needles may cut the fabric fibers. * As compared to Hemashield Double Velour Fabrics (<10mL/cm 2 /min). Measurements and testing completed by Maquet Cardiovascular. Data on file. Bench test results may not necessarily be indicative of clinical performance. 1. O Hara PJ, Hertzer NR, Mascha EJ, et al. A prospective, randomized study of saphenous vein patching versus synthetic patching during carotid endarterectomy. J Vasc Surg. Feb 2002;35: N=195.

6 product information Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch (in) (cm) M P P 0.2 x x 7.6 M P P 0.3 x x 7.6 M P P 0.3 x x 15.2 M P0* P* 1 x x 7.6 M P0* P* 1 x x 15.2 * Non-tapered End. Porosity: <5mL/cm 2 /min. Nominal Thickness: 0.36mm. Packaged 1 Per Box. 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. Hemashield knitted Double Velour Fabric M * * 0.2x3 0.6x7.6 M * * 0.2x x12.2 M * * 0.3x3 0.8x7.6 M * * 0.3x6 0.8x15.2 M x3 0.8x7.6 M x3 2.5x7.6 M x6 2.5x15.2 M x3 5.1x7.6 M x6 5.1x15.2 * Tapered End Porosity: <10mL/cm 2 /min. Nominal Thickness: 0.76mm Note: Maquet Cardiovascular is not responsible for the correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Hemashield woven Double Velour Fabric Trelex Natural Meshes M x6 2.5x15.2 M x3 5.1x7.6 M x6 5.1x15.2 Rectangle M x4 2.5x10.2 M x24 2.5x61 M x4 5.1x10.2 M * * 2x12 5.1x30.5 M x6 7.6x15.2 M ** ** 10x x35.6 Square M x6 15.2x15.2 Pre-Shaped M x4 4.6x10.2 Pre-Shaped with Opening M x4 4.6x10.2 Large Pre-shaped M x x14.2 Large Pre-shaped with Opening M x x14.2 Nominal Thickness: 0.635mm Packaged 3 Per Box * Packaged 2 Per Box ** Packaged 1 Per Box Porosity: <10mL/cm 2 /min.; Nominal Thickness: 0.46mm All Hemashield Double Velour Fabrics Packaged 1 Per Box Polyester Tape (Umbilical Tape), Sterile Polyester Tape (Umbilical Tape), non-sterile (in x yd) (mm x m) M /8x x91.4 M /16x x91.4 M /4x x91.4 Packaged 1 Spool Per Box M /8x x45.7 M /8x x61.0 M /8x x76.2 M /16x x45.7 M /16x x61.0 M /16x x76.2 M /4x x45.7 M /4x x61.0 M /4x x76.2 Packaged 2 Strips Per Package; 5 Packages Per Box