Scout Vessel Guard. A hydrogel membrane with exceptional handling characteristics.

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1 . A hydrogel membrane with exceptional handling characteristics. Pliable Permanent Pore size < 0.08μm Instruments and implants approved by the AO Foundation

2 . A hydrogel membrane with exceptional handling characteristics. Anterior Access Development Anterior spine surgery has been evolving since its inception in the early 1900 s. Many technique improvements have helped address the challenge of mobilizing the anterior abdominal muscles, peritoneal sac, and great vessels that is necessary to access the disc space. Protecting these sensitive vessels still remains a major challenge for this approach, especially during surgical revisions. Ito et al, J Bone Joint Surg Am. 1934;16: The ability to protect these sensitive vessels during a primary anterior spinal surgery is of utmost importance. It is desirable to limit contact between these vessels and any implanted device and/or inflammatory graft materials. The Scout Vessel Guard was designed with this protection in mind. Placed over these implanted materials and residing between the anterior spine and adjacent vessels, the provides protection to these sensitive vessels. The is a permanent implant. In the event that a revision surgery of the anterior spine is needed, the will be present and able to be visualized and identified. The presence of the can help the surgeon locate important surgical landmarks during these challenging cases. The is indicated as a cover for vessels during anterior vertebral surgery. The safety and effectiveness of this device for reducing the incidence, severity and extent of postoperative adhesion formation have not been established.

3 Material Background Hydrogels Hydrogels are water-swollen, crosslinked polymer structures that can be produced to achieve various geometries and ranges of material properties. These structures have a long history of clinical experience in areas such as orthopedic surgery, plastic surgery, heart surgery, drug delivery, and wound dressing. The formulation was developed to provide exceptional handling characteristics, minimal pore size, maximal surface smoothness, and easy size customization. The hydrogel material is prepared by a method of freezing and thawing without chemical cross-linking agents, making it an ideal material for implantation. The cryogenic hydrogel formulation used in the is approximately 75% water, with the balance being polymer. The polymer portion consists of a novel blend of mostly polyvinyl alcohol (PVA) and a small amount of polyvinyl pyrrolidone (PVP). The is packaged hydrated in phosphate buffered saline (PBS). PVA is a water-soluble synthetic polymer. When used in the human body, it is considered permanent and nonbiodegradable. Due to its high water content, biocompatibility, small pore size, and similar mechanical properties to human tissue, PVA hydrogels have been used for many years in various long-term applications, including embolic agents, vascular prostheses, and wound dressings. PVP is blended with PVA in the in order to increase the dissolution stability of the PVA hydrogel. PVP has been used for many years in various long-term medical applications, including breast implants and artificial corneas. PBS is primarily water, which serves as a medium for maintaining the physical characteristics of the hydrogel. Salts and buffers are included to ensure that the solution is isotonic and matches the ph of the human body.

4 Key System Features Smooth surface Semi-porous Maximum pore size of 0.08 microns particles larger than that cannot pass through 200x images: Smooth Surface Gore Scout Preclude Vessel Guard Vessel Guard Rough Surface Gore DualMesh ChronOS Hernia Mesh Bone Void Filler Permanent will not be absorbed; can be visualized and identified during anterior revision surgery of the spine Hydrophilic enhances fluid transport properties of the membrane and helps maintain hydration after implantation Provided hydrated minimal OR prep time Hydrostatic fluid over the surface of the membrane may help with positioning during implantation Pliable contours to anatomy : Hydrophilic Gore Preclude: Hydrophobic

5 Translucent, homogeneous, and white in color allows visualization of primary spine implant Customizable footprint can be trimmed intraoperatively to fit patient anatomy and application Can be used over a variety of spinal implants: Total disc replacements such as ProDisc-L (Figure 1) Stand-alone ALIF devices such as SynFix- LR (Figure 2) Anterior plates such as ATB, Antegra or Antegra-T (Figure 3) ALIF spacers such as FRA, ALIF or CC-ALIF (Figure 4)

6 Implants and Instruments S, 65 mm width x 55 mm height x 1 mm thick, sterile 55 mm 65 mm S, 65 mm width x 110 mm height x 1 mm thick, sterile 110 mm 65 mm

7 Instruments Also Available Atraumatic DeBakey Forceps

8 Spine 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) , Inc. or its affiliates. All rights reserved., Scout, chronos, ProDisc and SynFix are trademarks of, Inc. or its affiliates. Printed in U.S.A. 3/12 J11509-A Dual Mesh and Preclude are trademarks of W.L. Gore and Assoc. or its affiliates.