Home > Products > Otolaryngology–Head and Neck Surgery > Biodesign Otologic repair graft
- Intended Use and Clinical Applications
- Product Overview and Material Characteristics
- Instructions for Use and Surgical Technique
- Contraindications and Safety Precautions
The Cook Biodesign Otologic Repair Graft is designed for use as an implant to assist in surgical repair and to support the natural healing process in
various otologic procedures.
According to the approved instructions for use, applicable otologic procedures include, but are not limited to:
．Myringoplasty: May be used as an implant for tympanic membrane repair.．Tympanoplasty: May be used during tympanoplasty according to clinical needs.
Healthcare professionals should determine the appropriate use of the product based on the patient’s condition, surgical requirements, and the
extent of tissue repair.
The Cook Biodesign Otologic Repair Graft is a porous biomaterial composed of a decellularized extracellular matrix (ECM) derived from porcine
small intestinal submucosa (SIS).
SIS is obtained from the porcine small intestine and processed to retain its matrix components, including collagen types I, III, and VI
, glycosaminoglycans, proteoglycans, and fibronectin.
The product is designed for use as an implant during surgical repair, providing a material foundation for tissue repair. It is supplied sterile, is
intended for single use only, and should be used by appropriately trained healthcare professionals.
The Cook Biodesign Otologic Repair Graft is available in different sizes to accommodate surgical needs and may be trimmed and implanted
using aseptic technique.
Prepare the wound or surgical site according to standard surgical procedures and ensure adequate hemostasis. Select a graft that fully covers
the repair area based on the extent of the tissue defect.
The graft may be placed dry or hydrated before implantation using sterile saline or sterile lactated Ringer’s solution at room temperature.
Hydration time must not exceed 1 minute.
After placement, ensure that the graft adequately covers the defect and secure it with sutures or other appropriate methods as required by
the procedure. Follow appropriate postoperative care protocols and continue to monitor healing at the surgical site.
The Cook Biodesign Otologic Repair Graft is a biomaterial derived from porcine tissue and should not be used in patients with a known allergy
to porcine-derived materials.
Observe the following precautions:
．Single Use Only: Do not reprocess, resterilize, or reuse the product.．Sterile Packaging Integrity: Inspect the packaging before use. Discard the product if the packaging is damaged or contaminated, or if the
expiration date has passed.
．Handling Precautions: Avoid packing the external auditory canal with adhesive foreign materials or applying excessive pressure to the canal.
．Potential Complications: The use of implant materials in otologic surgery may result in allergic reactions, infection, inflammation, graft
displacement, persistent perforation, recurrence, or other related complications.
．Storage Conditions: Store at room temperature in a clean, dry environment and keep the original packaging intact.
