The Biodesign® Otologic Repair Graft aids the healing process of various otologic procedures1,2
Take a minimally invasive approach to tympanic membrane repair by eliminating donor site autologous tissue and additional scarring to the patient.3
The Biodesign® Otologic Repair Graft is a multi-layer biomaterial that aids in the natural healing process in various otologic procedures including, but not limited to myringoplasty and tympanoplasty. It offers an off-the-shelf alternative to autologous tissue that allows for a minimally invasive approach to tympanic membrane repair. It also eliminates the need for a donor site and, therefore, creates no additional scars for the patient.
Biodesign® Otologic Repair Graft Ordering Information
| Order Number | Reference Part # | Size cm | Nominal Thickness mm |
| G44840 | ENT-OTO-0.4-0.6 | 0.4,0.6 | 0.25 |
| G44839 | ENT-OTO-0.6-0.9 | 0.6,0.9 | 0.25 |
| G44451 | ENT-OTO-2.5X2.5 | 2.5 x 2.5 | 0.25 |
| G44452 | ENT-OTO-5X5 | 5.0 x 5.0 | 0.25 |
Biodesign® Otologic Repair Graft IFU
Risk Information:
INTENDED USE: The Biodesign® Otologic Repair Graft is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty. The device is supplied sterile and is intended for one-time use.
CONTRAINDICATIONS: The device should not be used for patients with known sensitivity to porcine material.
PRECAUTIONS: This device is designed for single use only, do not reprocess, resterilize, and/or reuse • Avoid packing external canal with adherent dressings or applying excessive pressure in the ear canal • Please take care when opening tray packaging to ensure that device remains seated in the tray.
POTENTIAL COMPLICATIONS: Complications that can occur with the use of surgical device materials in otologic procedures may include, but are not limited to: • abscess formation • allergic reaction • calcification • cholesteatoma • excessive redness, pain, swelling, or blistering • fever • infection • inflammation (initial application of device materials may be associated with transient, mild, localized inflammation) • mastoiditis • migration • persistence of perforation • recurrence • retraction pockets • seroma • squamous cysts • thickening of the tympanic membrane
VULNERABLE POPULATIONS: Safety data for this device has been collected in otherwise healthy populations. While no specific risks have been identified in vulnerable groups (e.g., patients with complex comorbidities or pregnancy), data in these populations is limited. Use in such cases should be guided by clinical judgment, including consultation with relevant specialists when appropriate.
References
1) D’Eredità R. Porcine small intestinal submucosa (SIS) myringoplasty in children: a randomized controlled study. Int J Pediatr Otorhinolaryngol. 2015;79(7):1085-1089.
2) Cass ND, Hebbe AL, Meier MR, et al. Pediatric primary tympanoplasty outcomes with autologous and non-autologous grafts. Otol Neurotol. 2022;43(1):94-100.
3) Redaelli De Zinis LO, Berlucchi M, Nassif N. Double-handed endoscopic myringoplasty with a holding system in children: preliminary observations. Int J Pediatr Otorhinolaryngol. 2017;96:127-130.
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