Official HCP Website | MACI®
Important Safety Information
Full Prescribing Information
Cartilage Repair Blog
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Intended for U.S. health care professionals only

For adult patients with ≤4 cm2 accessible defects of the knee

Take The Next Step
In Autologous Knee Cartilage Repair

Arthroscopic Delivery Now Approved
Arthroscopic Delivery Now Approved
MACI Arthro V-shuttle Deployed

Product Illustration

MACI Arthro incorporates the advantages of an arthroscopic approach with the long-term durability and established results of MACI.1,2

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Instrumentation 

MACI is autologous chondrocyte implantation, simplified3

MACI is less invasive than previous ACIs—may be done through mini-arthrotomy or arthroscopy.

MACI is reproducible—regardless of implantation technique or defect size, MACI delivers a controlled, uniform dose of characterized cells to the defect area.

MACI is simplified—does not require supplemental suture fixation.

MACI implant
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MACI repairs knee cartilage using your patient’s own chondrocytes.

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Dr. Kuhn

Watch notable orthopedic surgeons demonstrate delivery techniques for MACI

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References: 1. Saris D, Price A, Widuchowski W, et al; SUMMIT study group. Matrix-applied characterized autologous cultured chondrocytes versus microfracture: two-year follow-up of a prospective randomized trial. Am J Sports Med. 2014;42(6):1384-1394. 2. Brittberg M, Recker D, Ilgenfritz J, Saris DBF; SUMMIT Extension Study Group. Matrix-applied characterized autologous cultured chondrocytes versus microfracture: five-year follow-up of a prospective randomized trial. Am J Sports Med. 2018;46(6):1343-1351. 3. Flanigan DC, Sherman SL, Chilelli B, et al. Consensus on rehabilitation guidelines among orthopedic surgeons in the United States following use of third-generation articular cartilage repair (MACI) for treatment of knee cartilage lesions. Cartilage. 2021;13(suppl 1): 1782S-1790S.

Indication and Important Safety Information

Important Safety Information

Contraindications: MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, products of porcine or bovine origin; in patients with severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders; in patients who have undergone prior knee surgery in the past 6 months, excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant; or in patients unable to cooperate with a physician-prescribed post-surgical rehabilitation program.

Warnings and Precautions:
  • Malignancy: The risk of MACI in patients with malignancy in the area of cartilage biopsy or implant is unknown. Expansion of malignant or dysplastic cells present in biopsy tissue during manufacture and subsequent implantation may be possible.
  • Transmissible infectious diseases: Because patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases, cartilage biopsy and MACI implant may carry risk of transmitting infectious diseases.
  • Presurgical Comorbidities: Local inflammation or active infection in the bone, joint, and surrounding soft tissue, meniscal pathology, cruciate ligament instability, and misalignment should be assessed and treated prior to or concurrent with MACI implantation.
  • Product Sterility: Final sterility test results are not available at the time of shipping.

Adverse Reactions: The most frequently occurring adverse reactions reported for MACI (≥5%) were arthralgia, tendonitis, back pain, joint swelling, and joint effusion. Serious adverse reactions reported for MACI were arthralgia, cartilage injury, meniscus injury, treatment failure, and osteoarthritis.

Specific Populations:
  • Use of MACI in pediatric patients (younger than 18 years of age) or in patients over 65 years of age has not been established.
  • The MACI implant is not recommended during pregnancy. For implantations post-pregnancy, the safety of breastfeeding to an infant has not been determined.

To report negative side effects, contact Vericel Corporation at 1-800-453-6948 or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.

Please see Full Prescribing Information.

Indication

MACI® 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.

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.