Autologous cultured chondrocytes and pork collagen

Preparation and Implantation Procedure Collection of Autologous Cartilage Biopsy The procedure may be performed arthroscopically. Using a ring curette or curved notchplasty gouge, harvest at least two healthy full-thickness cartilage specimens from a lesser load-bearing area of the damaged knee, such as the lateral intercondylar notch, the superior lateral trochlear ridge, or the superior medial trochlear ridge.

The specimens should measure approximately 5 x 8 mm each (200-300 mg total). The biopsy must be full-thickness and should include a small amount of subchondral bone, which will be removed prior to processing the biopsy. Some punctate bleeding may occur at the site of biopsy harvest. Using sterile technique, place the biopsy into transport medium bottle.

Pre-Operative Preparation Confirm that the patient’s identity matches the patient identifiers on the MACI labels. Inspect the sealed MACI shipping box for any evidence of damage. Open the MACI shipping box and inspect the internal packaging for leaks (liquid) in the outer bag or self-seal pouch containing the bottle holding the MACI implant or for any evidence of damage or contamination.

DO NOT USE if the patient identifiers do not match, or there are signs of leaking or damage to the packaging. Contact MACI representative immediately or call Vericel Customer Care at 1-800-453-6948. After inspection, keep MACI in its original packaging and store at room temperature until the surgical site has been prepared.

Arthroscopic delivery is for lesions that are a maximum of 4 cm 2 in size and are accessible using an arthroscopic approach. Implantation Procedure Perform implantation procedure during arthrotomy or arthroscopy using sterile surgical techniques. Follow the implantation with an appropriate, physician-prescribed rehabilitation program [see Dosage and Administration].

NOTE: The MACI Surgical Implantation Kit may be used to assist with MACI knee surgery via arthrotomy. The MACI Arthroscopic Instruments may be used to assist with arthroscopic delivery. Ensure instruments selected are appropriately matched to the defect size. Preparing Defect Arthroscopic Delivery: Create an appropriately placed portal to to visualize the defect to be treated athroscopically.

Under direct arthroscopic vision insert a spinal needle directly over the center of the cartilage defect. Use the location determined by the spinal needle to create a second portal for the cannula (e.g., MACI Cannula Assembly) directly perpendicular to the defect. Measure the length and width of the defect using a measurement probe (e.g., measurement device) as shown in Figure 1 .

Figure 1: Measure defect size – Arthroscopic Method Select and insert the appropriate size cannula (e.g., MACI Cannula Assembly) in this second portal directly over the center of the cartilage defect. Remove trocar from cannula assembly. Select the appropriate size cutter (e.g., MACI Arthroscopic Cutter) based on the defect size.

Insert the cutter through the cannula and position over the cartilage defect. Adjust the angle of the cutter head, and apply pressure to score the cartilage surrounding the defect ( Figure 2 ). Bring the cutter head back to its original position prior to removal from the joint. Figure 2: Score Cartilage – Arthroscopic Method For Arthroscopic and Arthrotomy Delivery: For chondral defects, remove all damaged and fibrous tissue on the defect bed using appropriate instruments (e.g., MACI Rake Curette, MACI Square Curette and MACI Open-Ring Curette).

Debride the defect bed back to stable cartilage with vertical walls down to the subchondral bone by removing as little healthy cartilage as possible ( Figure 3 ). Do not penetrate the subchondral bone. Figure 3: Preparing Defect Bed For osteochondral defects, debride the defect bed back to stable cartilage with vertical walls down to healthy stable bone.

Avoid bleeding through the subchondral plate. If bleeding occurs, use a suitable hemostatic agent to control the bleeding. Preparing MACI Implant Unpacking MACI implant box (outside sterile field). Unpack MACI implant shipping box. Staff responsible for removing bottle from packaging and decanting contents into sterile container in sterile field should wear protective gown, gloves, and eyewear.

Remove the outer bag containing a bottle holding the MACI implant. Remove the self-seal pouch containing the bottle from the outer bag ( Figure 4 ). Figure 4: Bottle in Self-Sealed Pouch Tear notches on the self-seal pouch to open the pouch and remove the bottle. Note: Keep the bottle upright and do not open the cap until ready to use the MACI implant.

Note: Do not remove the MACI implant from the bottle until ready to be used. Unpacking the MACI implant bottle ( Figure 5 ) When ready, a team member outside the sterile field but adjacent to the sterile prep table, will twist open and remove the cap from the bottle. The outside of the bottle is not sterile, ensure that the MACI implant or sterile instruments do not come in contact with the outside of the bottle.

On sterile field, place sterile dish or container of sufficient size to hold contents of MACI implant bottle, approximately 120 mL of media. Ensure MACI implant is free floating and not adhered to inner surface of bottle. Aseptically and rapidly decant the bottle contents into sterile dish including all transport media and the MACI implant.

Note: If the MACI implant remains in the bottle, media from the sterile dish can be returned to the bottle via sterile syringe and decanted again. Alternatively, if the MACI has remained in the neck of the bottle, it can be extracted using sterile non-toothed forceps to grasp an edge or corner. Figure 5: Unpacking MACI Implant The MACI implant has a rough side and a smooth side.

The cells are seeded on the rough side. A notch in the lower left corner of the implant in landscape orientation indicates that the cell-side is facing up. The cell-side of the MACI implant should remain facing up at all times until placement into the defect. If the MACI implant is cell-side down after decanting from bottle, a sterile field team member will flip the membrane using two sterile non-toothed forceps.

The MACI implant should only be grasped by corners or edges. Sterile field team member will use two sterile non-toothed forceps to grasp the MACI implant corners and place the MACI implant cell-side up onto a sterile work surface (e.g., MACI Cutting Block or MACI Arthroscopic Cutting Block). A notch in the lower left corner of the implant indicates that the cell-side is facing up.

Note: The MACI implant must remain hydrated with the shipping media. Use the decanted media from the sterile dish to maintain implant hydration after removal from the bottle. Shaping the MACI implant Avoid excessive manipulation of the MACI implant. Throughout the shaping and delivery of the MACI implant it is important to keep track of membrane orientation to facilitate placing cells in the base of the defect.

Arthroscopic Delivery: Using the MACI Cutter that was packaged together with the Arthroscopic Cutter, place the MACI Cutter on top of the MACI implant and use light thumb pressure or lightly tap with a mallet to cut to size ( Figure 6 ). Figure 6: Cut MACI Implant Place any remaining MACI implant into a separate intermediary dish with adequate media to keep the implant hydrated.

Arthrotomy Delivery: Create an exact template of the defect ( Figure 7 ). Figure 7: Creating Defect Template Create orientation markers on the template to assist with proper orientation of the MACI implant. Turn the marked template over to ensure that the cells will be properly placed into the defect. To maintain proper orientation, turn the template over and place it underneath the MACI implant, against the smooth, non-seeded side.

The template should be visible through the translucent implant. Note: Ensure minimal contact with the cell-seeded surface of the MACI implant. Using the template as a guide, cut the MACI implant to the correct size and shape. Place the custom-cut implant into a sterile intermediary dish, ensuring the cell-side up orientation.

Ensure MACI implant remains hydrated at all times. Using sterile syringe, hydrate implant using decanted media. Place any remaining MACI implant into a separate intermediary dish with adequate media to keep the implant hydrated. Placing MACI Implant Arthroscopic Delivery Turn off fluid and drain the knee. If using a cannula with a dam (e.g., MACI Arthroscopic instrument), remove the dam from the cannula ( Figure 8 ).

Do not insert the MACI implant through a cannula dam. Figure 8: Remove Cannula Dam A dry arthroscopic environment is essential for implantation. Remove any close liquid collections with the suction tip and ensure the defect area is dry and free of bleeding (e.g., using the spongy end of the MACI Applicator) ( Figure 9 ).

Figure 9: Dry Defect Select appropriate size MACI V-Shuttle Delivery Device that matches the MACI Cannula diameter size used. Verify the V-Shuttle delivery device functionality by pressing the plunger to deploy the antennae prior to use. Gently place the MACI implant cell-side (rough side) up on the tip of the MACI V-Shuttle delivery device using forceps ( Figure 10 ).

Maintain the orientation of the V-Shuttle in an upright position. Figure 10: Placement on MACI V-Shuttle Delivery Device Apply a thin layer of fibrin sealant to the entire base of the defect (bone) bed. Insert the MACI V-Shuttle with the loaded MACI implant into the MACI cannula ensuring the outer fins of the V Shuttle are oriented inferior and superior in line with the lesion.