The SCOUT® Vessel Guard is a flexible, non-absorbable membrane, allowing it to contour to the anatomy. It is made from hydrogel (water, polyvinyl alcohol (PVA) and polyvinyl pyrrolidone (PVP)) and is packed wet in phosphate buffered saline (PBS). The SCOUT Vessel Guard is designed to be placed between the anterior spine and proximate vessels during anterior lumbar surgery.
The SCOUT Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.
Use of the DePuy Synthes Spine's SCOUT Vessel Guard is contraindicated for:
Use of this product in applications other than those indicated has the potential for serious complications, such as pullout of the fixation or undesired healing to surrounding tissues.
Patients with infection, e.g., inflammatory, bacterial bone diseases (posttraumatic or chronic osteomyelitis) and soft-tissue infections at the site of proposed implantation.
Patients with demonstrated allergy or foreign body sensitivity to any of the implant materials.
One of the potential risks identified with any surgical procedure is death. Other potential risks associated with the use of this device which may require additional surgery, include:
Discard and DO NOT USE previously opened or damaged devices. Use only devices that are packaged in unopened and undamaged packages.
DO NOT USE if there is loss of sterility of the device.
DO NOT USE if the device appears dehydrated or if moisture is not visible in the inner package.
The DePuy Synthes Spine's SCOUT Vessel Guards are sterilized by gamma radiation. DO NOT RESTERILIZE. CONTENTS STERILE UNLESS INNER PACKAGE IS OPENED OR DAMAGED.
Do not use the SCOUT Vessel Guard after the expiration date printed on the package label.
Product should be stored at room temperature, 15°C–30°C (59°F – 86°F).
The safety and effectiveness of this device for reducing the incidence, severity and extent of postoperative adhesion formation have not been established.
|Maximum pore size of .08 microns||Particles larger than that cannot pass through|
|Enhancing fluid transport properties of membrane and helps maintain hydration after implantation|
|Fluid over the surface of the membrane may help with positioning during implantation|
|Pliable||Contours to anatomy|
|Will not be absorbed, translucent, homogenous and white in color||Provides ability to be visualized and identified during anterior revision surgery of the spine|
|Customizable footprint||Can be trimmed intraoperatively to fit patient anatomy and application|