Avance Nerve Graft

2 DOSAGE AND ADMINISTRATION • AVANCE is intended for surgical implantation. ( 2.1 ) • The recommended number of AVANCE required is based on the nerve deficits identified for repair. ( 2.1 ) • AVANCE may be trimmed to accommodate the size of the deficits. Each AVANCE is for implantation in a single patient only. ( 2.1 ) • See full prescribing information for AVANCE preparation and administration instructions. ( 2.2 ) ( 2.3 ) 2.1 Recommended Dose AVANCE is intended for surgical implantation. • The recommended number of AVANCE required is based on the nerve deficits identified for repair. • AVANCE may be trimmed to accommodate the size of the deficits. Each AVANCE is intended for implantation in a single patient only. • AVANCE is available in 16 size combinations of different lengths and diameters to fit the size and diameter of the nerve(s) to be treated. Healthcare professionals should carefully assess the length and diameter of the nerve deficit(s) to be treated to determine the most suitable quantity and sizes of AVANCE required for treatment. [see Dosage and Administration ( 2.3 )]. Refer to Table 1 for the available sizes of AVANCE: Table 1. Available Sizes of AVANCE Length (mm) Diameter Range (mm) AVANCE is available in the lengths and diameters as shown in Table 1 . The graft diameter is measured at each end of the graft, and variation along the length can occur in human tissue. Length Range (mm) 15 1 to 2 15 to 21 15 2 to 3 15 to 21 15 3 to 4 15 to 21 15 4 to 5 15 to 21 30 1 to 2 30 to 36 30 2 to 3 30 to 36 30 3 to 4 30 to 36 30 4 to 5 30 to 36 50 1 to 2 50 to 56 50 2 to 3 50 to 56 50 3 to 4 50 to 56 50 4 to 5 50 to 56 70 1 to 2 70 to 76 70 2 to 3 70 to 76 70 3 to 4 70 to 76 70 4 to 5 70 to 76 2.2 Preparation Receipt and Storage of AVANCE: AVANCE is shipped on dry ice in validated insulated shipping containers. AVANCE must remain frozen at ≤-40°C (≤-40°F) and be kept frozen until use. For a complete description of the AVANCE packaging configuration and storage conditions, [ see How Supplied/Storage and Handling ( 16 )] . AVANCE is to be prepared in an appropriate surgical environment. Supplies: The following supplies are not included but are needed for preparation: • Room temperature sterile normal saline or sterile Lactated Ringer’s solution (LRS). Preparation Instructions: Following standard surgical site preparation for exposure, mobilization, and trimming of the peripheral nerve to be treated, determine the size and/or number of AVANCE that need to be thawed. [see Dosage and Administration ( 2.3 )]. The following instructions are for preparing one AVANCE. Two team members (one sterile field team member and one team member outside the sterile field) are required. If two or more AVANCE are required, prepare them individually. AVANCE thawing should take approximately 6 minutes. 1. The team member outside the sterile field removes the desired AVANCE from the freezer and transports it to the operating room. 2. The team member outside the sterile field removes the zip top bag and opens and removes the carton. 3. The team member outside the sterile field peels open the seal of the outer foil-poly pouch and aseptically presents the inner Tyvek ® -poly pouch to the sterile field team member for placement in the sterile field. The sterile field team member aseptically removes the inner Tyvek-poly pouch presented by the team member outside the sterile field from the inside of the outer foil-poly pouch and places it in the sterile field. 4. In the sterile field, the sterile field team member peels open the inner Tyvek-poly pouch and removes the clamshell tray. 5. The sterile field team member opens the clamshell tray and fills the pre-molded thawing reservoir with room temperature sterile normal saline or sterile LRS ( Figure 1 ). Do not heat AVANCE or add heated saline or LRS to the graft. Figure 1: Thawing AVANCE with sterile saline or LRS. Figure 1: Thawing AVANCE with sterile saline or LRS. 6. Do not implant a partially or fully frozen product. Allow AVANCE to thaw completely before use, which will take approximately 6 minutes. AVANCE must be thawed until it reaches room temperature without heating. Once thawed, AVANCE must be either implanted or discarded within 12 hours. Figure 1 2.3 Administration AVANCE is implanted in appropriate sterile conditions by a trained licensed physician. Follow the steps below for surgical implantation of AVANCE: 1. Prior to implanting AVANCE, it is important to trim back the nerve to be repaired until healthy nerve tissue is reached. Healthy nerve tissue can be identified by pouching fascicles and punctate bleeding. 2. After trimming, if applicable, place the extremity in extension and measure the deficit as well as the diameter of the nerve to be repaired. 3. Select an AVANCE of an appropriate length that ensures there will be no tension on the graft when implanted and of a diameter that most closely approximates the nerve to be repaired. AVANCE may be trimmed to accommodate the size of the deficits. 4. When handling AVANCE, only hold it by the outermost epineurium and avoid crimping or crushing the graft. 5. Coaptation can be achieved by multiple methods. Surgical methods should be tailored to the type of injury and goals of reconstruction, as well as body region, nerve type, and size of discontinuity. One method is to use appropriately sized non-absorbable sutures such as 8-‑0 or 9-0, which should be placed only through the epineurium of the nerve. Either end of AVANCE can be coapted to the proximal nerve to be repaired. 6. To bridge the defect, secure the sutures, ensuring that they are not overtightened. The nerve being repaired and AVANCE should be lightly touching, but they should not overlap.

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1 INDICATIONS AND USAGE AVANCE is an acellular nerve scaffold indicated for the treatment of adult and pediatric patients aged one month and older with: • Sensory nerve discontinuity (≤25 mm).