COOK-Everis- ENT-OTO-5X5-Biodesign Otologic Repair Graft G44452

    Condition: New
    Part #: ENT-OTO-5X5

    $712.50

    SKU: ENT-OTO-5X5 Category:
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    Description

    The Biodesign Otologic Repair Graft (G44452) by Cook Medical is a breakthrough bioabsorbable implant engineered to streamline reconstructive ear procedures. Crafted from porcine small intestinal submucosa (SIS), this advanced graft provides a robust scaffold for the repair and reinforcement of the tympanic membrane and other otologic structures.

    By utilizing a natural extracellular matrix (ECM), the Biodesign graft eliminates the need for autologous tissue harvesting, significantly reducing patient morbidity and operating room time while maintaining clinical outcomes comparable to traditional fascia grafts.

    Core Technology: The SIS Advantage

    At the heart of the Everis ENT-OTO-5X5 is Small Intestinal Submucosa (SIS) technology. Unlike synthetic meshes or heavily processed dermis, SIS is a complex, naturally occurring extracellular matrix. It is specifically processed to remain sterile and non-pyrogenic while preserving the essential proteins—such as collagen, glycosaminoglycans, and growth factors—that are vital for organized tissue regeneration.

    Mechanism of Action

    The Biodesign graft does not simply act as a passive plug; it functions as an active biological scaffold.

    • Cellular Infiltration: Once implanted, the graft’s porous structure allows host cells to migrate into the matrix.

    • Vascularization: The material supports rapid neovascularization, ensuring the healing tissue has a consistent blood supply.

    • Remodeling: Over time, the porcine scaffold is completely absorbed and replaced by the patient’s own organized host tissue, resulting in a durable, living repair of the ear drum or mastoid.

    Clinical Applications and Uses

    This versatile graft is indicated for various otologic procedures where tissue reinforcement or replacement is required:

    • Myringoplasty: For the repair of small to medium tympanic membrane perforations.

    • Tympanoplasty: Used in more extensive reconstructions of the middle ear and eardrum.

    • Mastoidectomy: Provides a biological barrier and reinforcement during mastoid cavity reconstruction.

    • Atticotomy Repairs: Suitable for reinforcing the scutum or other bony defects in the ear canal.

    Key Advantages in Otologic Surgery

    The Biodesign Otologic Repair Graft offers distinct benefits for both the surgical team and the patient:

    • No Donor Site Morbidity: Eliminates the need to harvest temporalis fascia or tragal cartilage, removing the risk of secondary incision infections and pain.

    • Superior Handling: The 0.25 mm thickness provides the ideal balance of strength and flexibility. It can be easily trimmed to size and maintains its shape when wet, facilitating precise underlay placement.

    • High Success Rates: Clinical data demonstrates closure rates between 83% and 100%, matching the gold standard of autologous tissue.

    • OR Efficiency: By removing the “harvesting step” of the procedure, surgeons typically save 10 minutes of operative time per case.

    Technical Specifications

    Feature Specification
    Product Code G44452
    Reference Number ENT-OTO-5X5
    Material Porcine Small Intestinal Submucosa (SIS)
    Dimensions 5 cm x 5 cm
    Thickness 0.25 mm
    Format Sterile, single-use sheet
    Storage Controlled room temperature

    Economic Impact and ROI

    Implementing the Biodesign graft can improve facility throughput and cost-effectiveness. The reduction in operative time (approximately 10 minutes) allows for better OR utilization. Furthermore, the reduction in post-operative complications related to donor-site morbidity can lower the total cost of care and improve patient satisfaction scores, making it a high-value alternative to traditional methods.


    Frequently Asked Questions

    What is the primary material used in the Biodesign Otologic Repair Graft?

    The graft is composed of porcine small intestinal submucosa (SIS). This is a naturally occurring, non-crosslinked extracellular matrix that contains essential proteins to facilitate tissue remodeling. It is processed to be sterile and bioabsorbable, eventually being replaced by the patient’s own native tissue during the healing process.

    How does this graft compare to traditional autologous fascia?

    While autologous fascia is often considered the gold standard, the Biodesign graft offers comparable closure rates of 83-100%. The primary advantage is the elimination of a secondary donor site incision, which reduces patient pain and potential complications while saving the surgeon approximately ten minutes of operative time.

    Can the Biodesign graft be used for large tympanic membrane perforations?

    Yes, the 5×5 cm dimensions allow for significant customization. Surgeons can trim the sterile sheet to the exact size required for the defect. Its 0.25 mm thickness and mechanical properties make it suitable for various underlay techniques in both myringoplasty and more complex tympanoplasty procedures.

    Is the graft permanent, or does it stay in the ear indefinitely?

    The Biodesign Otologic Repair Graft is completely bioabsorbable. Rather than remaining as a permanent foreign body, it acts as a temporary scaffold. As host cells infiltrate the matrix and new blood vessels form, the porcine material is gradually remodeled and replaced by the patient’s own healthy tissue.

    What are the storage requirements for the G44452 graft?

    The Biodesign graft is designed for convenience and should be stored in a clean, dry environment at controlled room temperature. Because it does not require refrigeration or specialized freezing, it is easy to manage within a hospital or ambulatory surgery center’s standard inventory system.

    How does the graft behave during surgical handling and placement?

    The material is engineered for excellent clinical handling. It is easy to cut to a precise shape while dry and remains manageable once hydrated. Its structural integrity allows for easy manipulation during underlay or overlay placement, ensuring it stays in position to support effective epithelialization.

    Listing Terms & Conditions

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    Due to worldwide shipping delays, it is possible that items listed could be on backorder. If the item is unavailable for an extended period, we sincerely apologize for the delay. In this case, we will refund you as soon as we are notified of the backorder and contact you with the confirmation of refund.