MACI Implant

Generic name: autologous cultured chondrocyte

Indications and Usage for MACI Implant

MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults.

Limitations of Use

• Effectiveness of MACI in joints other than the knee has not been established.
• Safety and effectiveness of MACI in patients over the age of 55 years have not been established.

MACI Implant Dosage and Administration

For Autologous Implantation Only.

Contact Vericel at 1-800-453-6948 or www.MACI.com regarding training materials for surgical implantation of MACI.

Dosage

• The amount of MACI Implanted depends on the size (surface area in cm2) of the cartilage defect. The surgeon should trim the MACI Implant to the size and shape of the defect, to ensure the damaged area is completely covered.
• MACI Implant is for single-use. Multiple implants may be used if there is more than one defect. The size of MACI is adjusted for the size of each cartilage defect.

Preparation and Implantation Procedure

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.

Implantation Procedure

• Perform implantation procedure during arthrotomy using sterile surgical techniques...