Biodesign® Sinonasal Repair aids in the natural healing process during nasal mucosal tissue repair.¹
Support remucosalization and eliminate the need to harvest graft tissue from other parts of the body.²
The Biodesign Sinonasal Repair Graft is intended to separate tissue or structures compromised by surgical trauma and act as an adjunct to aid in the natural healing process.³
Risk Information:
INTENDED USE: The Biodesign Sinonasal Repair Graft is intended to separate tissue or structures compromised by surgical trauma and act as an adjunct to aid in the natural healing process. The device is indicated for use where an open wound dressing material is required in the nasal and/or sinus cavities following nasal and/or sinus surgery where separation of tissues or structures is desired during nasal septal perforation repair and donor site repair. The device is supplied sterile and is intended for one-time use.
CONTRAINDICATIONS: This graft is derived from a porcine source and should not be used in patients with known sensitivity to porcine material.
PRECAUTIONS: The graft is designed for single use only. Do not reprocess, resterilize, and/or reuse • The graft should not be applied until excessive exudate, bleeding, acute swelling, and infection is controlled • Ensure that all layers of the graft are secured during fixation.
POTENTIAL COMPLICATIONS: Complications that can occur with the use of surgical graft materials in nasal/ sinus surgery may include, but are not limited to: • allergic reaction • bleeding • blistering • excessive redness • hematoma • infection/toxic shock syndrome • inflammation • nasal obstruction • pain • persistence of perforation or recurrence
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.
Sinonasal Repair Products Ordering Information
| Order Number | Reference Part # |
| G35947 | ENT-TRG-1X2 |
| G35948 | ENT-TRG-2X3 |
| G35949 | ENT-TRG-4X7 |
| G35950 | ENT-TRG-7X10 |
Sinonasal Repair IFU
References
1) Greywoode J, Hamilton J, Malhotra PS, et al. Repair of nasal septal perforation with porcine small intestinal submucosa xenograft. J Otol Rhinol. 2012;1(2).
2) Ambro BT, Zimmerman J, Rosenthal M, Pribitkin EA, Nasal septal perforation repair with porcine small intestinal submucosa. Arch Facial Plast Surg. 2003;5(6):528-529.
3) Nayak JV, Rathor A, Grayson JW, et al. Porcine small intestine submucosal grafts improve remucosalization and progenitor cell recruitment to sites of upper airway tissue remodeling. Int Forum Allergy Rhinol. 2018;8(10):1162-1168.