Hemashield Platinum Finesse™ Surgical Fabrics, Meshes, and Tapes OVER 45 YEARS TEXTILE GRAFT TECHNOLOGY EXPERIENCE MAQUET

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Hemashield Platinum Finesse™ Surgical Fabrics, Meshes, and Tapes OVER 45 YEARS TEXTILE GRAFT TECHNOLOGY EXPERIENCE MAQUET – THE GOLD STANDARD

A comprehensive, proven vascular graft portfolio ming vascular repair procedures by providing products desi- and exceptional professional support make MAQUET gned to help improve the lives of patients with specific vas- Cardiovascular a valuable asset to cardiac, thoracic and vascular therapy needs. Trusted for over 20 years, MAQUET's cular surgeons and their teams. The HEMASHIELD Platinum HEMASHIELD® Grafts are the most used, most studied Finesse Ultra-Thin Knitted Cardiovascular Patch is used for vascular products available in the market today. More than cardiac and vascular patch grafting. MAQUET offers conve- 2 million HEMASHIELD grafts have been implanted world- nient and innovative clinical solutions for cardiothoracic and wide, demonstrating clinical efficacy and improved patient abdominal aneurysms and peripheral vascular therapy opti- outcomes. ons including a line of surgical fabrics, meshes and tapes designed for a range of different clinical applications. MAQUET – The Gold Standard. MAQUET strives to be the first choice to surgeons perfor- Hemashield Platinum Finesse™ Surgical Fabrics, Meshes, and Tapes 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/cm2/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 Hemashield Platinum Finesse™ Ultra-Thin Knitted Cardiovascular Patch similar clinical results to autogenous saphenous vein when used for carotid endarterectomy1

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 Strong, tight braided. The polyester tape reduces risk of the strength to provide excellent reinforcement of soft tissue tissue trauma while promoting effective retraction. and improved handling characteristics. Hemashield Platinum Finesse™ Surgical Fabrics, Meshes, and Tapes INstructions for Use

Hemashield Platinum Finesse™ ULTRA-THIN TRELEX NATURAL® Meshes KNITTED CARDIOVASCULAR PATCH, HEMASHIELD® double velour Fabrics Indications: TRELEX NATURAL Meshes are indicated to reinforce soft tissue where weakness exists, e.g. for repair of hernia and chest wall defects. Indications: HEMASHIELD Knitted Double Velour Fabric, HEMASHIELD Woven Double Velour Fabric and HEMASHIELD PLATINUM FINESSE Ultra- Contraindications: None known. Thin, Knitted Cardiovascular Patch are indicated for cardiac and vascular patch grafting. The fabrics are also recommended for use in patients requiring systemic Warnings: 1. Fabrics contaminated with human body fluid from previous heparinization prior to, or during, surgery. The GUIDELINE® stripe on the surgery should not be used. 2. Destroy any portion of a fabric which has HEMASHIELD Knitted Double Velour Fabric and the HEMASHIELD PLATINUM been contaminated by body fluid. Do not attempt to wash and resterilize a FINESSE Ultra-Thin, Knitted Cardiovascular Patch indicates the direction of contaminated fabric. greatest tensile strength; the HEMASHIELD Woven Double Velour Fabric is equally strong in both directions. 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 Contraindications: This prosthesis is not indicated for use in place, nonabsorbable, monofilament sutures are recommended. As with any reconstruction of hernias or tissue deficiencies, or reconstruction or repair of textile construction, it is suggested that only taper point needles be used. The passive biological membranes (such as dura mater, pericardium, or peritoneum) use of taper cut or other cutting needles may damage the textile fibers. 3. SINGLE USE ONLY. 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 polyester tape (umbilical tape) implanted in patients with a known sensitivity to products of bovine origin. Indications: Retraction of blood vessels, nerves, organs and ligaments. Precautions: 1. If surgical technique requires use of instruments with the fabric, use atraumatic instruments. 2. It is suggested that only taper-point Contraindications: None known. 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 Warnings: 1. SINGLE USE ONLY. 2. Fabrics contaminated with human is essential. Use sharp surgical scissors to trim the HEMASHIELD Knitted Double body fluid from previous surgery should not be used. Destroy any portion of a Velour Fabric and the HEMASHIELD PLATINUM FINESSE Ultra-Thin, Knitted fabric which has been contaminated by body fluid. Do not attempt to wash and Cardiovascular Patch. 5. The HEMASHIELD Woven Double Velour fabric should resterilize a contaminated fabric. be cut with a low temperature, disposable cautery (e.g., ≈900°F/≈500°C) to prevent raveling. 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.

Cardiovascular velour, knitted, woven Fabrics

Indications: Velour Fabrics - For arterial and ventricular septal defects, patch To place an order, grafting and patch repair of carotid endarterectomy. Knitted Fabrics - For arterial and ventricular septal defects, patch grafting. Woven Fabric - Outflow tract contact customer service patch, thoracic aortoplasty, or whenever blood loss is a concern. at 888.272.1001

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/cm2/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;35:324-332. N=195. Hemashield Platinum Finesse™ Surgical Fabrics, Meshes, and Tapes product information

Hemashield Platinum Finesse™ Ultra-Thin Hemashield® knitted Double Velour Fabric Knitted Cardiovascular Patch UPN Order Number Width x Length Width x Length UPN Order Number Width x Length Width x Length (in x in) (cm x cm) (in) (cm) M002000195250* 019525* 0.2x3 0.6x7.6 M00202019575P0 019575P 0.2 x 3 0.6 x 7.6 M002000195280* 019528* 0.2x4.8 0.6x12.2 M00202019579P0 019579P 0.3 x 3 0.8 x 7.6 M002000195290* 019529* 0.3x3 0.8x7.6 M00202019585P0 019585P 0.3 x 6 0.8 x 15.2 M002000195100* 019510* 0.3x6 0.8x15.2 M00202019530P0* 019530P* 1 x 3 2.5 x 7.6 M002000195090 019509 0.3x3 0.8x7.6 M00202019561P0* 019561P* 1 x 6 2.5 x 15.2 M002000195140 019514 1x3 2.5x7.6 * Non-tapered End. M002000195170 019517 1x6 2.5x15.2 Porosity: <5mL/cm2/min. Nominal Thickness: 0.36mm. M002000195240 019524 2x3 5.1x7.6 Packaged 1 Per Box. M002000195270 019527 2x6 5.1x15.2

The C-code used for this product is C1768, Vascular grafts. C-codes are used * Tapered End for hospital outpatient device reporting for Medicare and some private payers. Porosity: <10mL/cm2/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

UPN Order Number Width x Length Width x Length (in x in) (cm x cm) ® Trelex Natural Meshes M002000196170 019617 1x6 2.5x15.2 UPN Order Number Width x Length Width x Length M002000196240 019624 2x3 5.1x7.6 (in x in) (cm x cm) M002000196270 019627 2x6 5.1x15.2

Rectangle Porosity: <10mL/cm2/min.; Nominal Thickness: 0.46mm All Hemashield Double Velour Fabrics Packaged 1 Per Box M002000199101 019910 1x4 2.5x10.2 M002000199111 019911 1x24 2.5x61 M002000199201 019920 2x4 5.1x10.2 Polyester Tape (Umbilical Tape), Sterile M002000199211* 019921* 2x12 5.1x30.5 UPN Order Number Width x Length Width x Length M002000199301 019930 3x6 7.6x15.2 (in x in) (cm x cm) M002000199400** 019940** 10x14 25.4x35.6 M002000194011 019401 1/8x18 0.32x45.7 Square M002000194021 019402 1/8x24 0.32x61.0 M002000194031 019403 1/8x30 0.32x76.2 M002000199601 019960 15.2x15.2 6x6 M002000194111 019411 3/16x18 0.48x45.7 Pre-Shaped M002000194121 019412 3/16x24 0.48x61.0 M002000194131 019413 3/16x30 0.48x76.2 M002000199701 019970 4.6x10.2 1.8x4 M002000194211 019421 1/4x18 0.64x45.7 Pre-Shaped with Opening M002000194221 019422 1/4x24 0.64x61.0 M002000194231 019423 1/4x30 0.64x76.2 M002000199711 019971 1.8x4 4.6x10.2 Packaged 2 Strips Per Package; 5 Packages Per Box Large Pre-shaped

M002000199721 019972 2.4x5.6 6.1x14.2 Polyester Tape (Umbilical Tape), non-Sterile Large Pre-shaped with Opening UPN Order Number Width x Length Width x Length M002000199731 019973 2.4x5.6 6.1x14.2 (in x yd) (mm x m) M002000194000 019400 1/8x100 3.2x91.4 Nominal Thickness: 0.635mm M002000194100 019410 3/16x100 4.8x91.4 Packaged 3 Per Box M002000194200 019420 1/4x100 6.4x91.4 * Packaged 2 Per Box ** Packaged 1 Per Box Packaged 1 Spool Per Box www.maquet.com 1-888-899-2874 Fax: 1-888-880-2874 Phone: 95134 CA Jose, San Drive Baytech 170 LLC Cardiovascular MAQUET and prevention within healthcare and life science and MAQUET for for Surgical MAQUET Workplaces, Cardiovascular andCriticalCare. and science life and healthcare within prevention and cotrol infection for GETINGE diagnostics, and surfaces therapeutic handling and hygiene, disinfection, DVT prevention, medical beds, patient for ArjoHuntleigh brands the under supplied are nologies tech- and service Equipment, sciences. life and healthcare within efficiency cost and enhancement quality to contribute that systems and equipment of provider global leading a is Group Getinge LT7900270