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EXPLORE MACI CLINICAL WEBINARS FOR THE LATEST INNOVATIONS IN KNEE CARTILAGE REPAIR

EXPLORE MACI CLINICAL WEBINARS FOR THE LATEST INNOVATIONS IN KNEE CARTILAGE REPAIR

Throughout the “Work of Art” surgical education series, physicians discuss the latest insights on knee cartilage injury and strategies for repair. All MACI webinars are available on demand for U.S. based healthcare professionals.

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Is MACI Knee Cartilage Repair Right for Your Patients?

Is MACI Knee Cartilage Repair Right for Your Patients?

MACI is the third generation of autologous chondrocyte implantation and has made multiple advancements that allow for greater flexibility in treating symptomatic knee cartilage defects in the adult knee.

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MACI vs. ACI: How the Third Generation ACI Repairs Knee Cartilage

MACI vs. ACI: How the Third Generation ACI Repairs Knee Cartilage

While orthopedic surgeons have used autologous chondrocyte implantation (ACI) for decades, matrix-induced ACI (MACI) is the third and latest ACI generation to repair cartilage defects in the adult knee. What differentiates MACI from previous generations of ACI is its simplified, cutting-edge approach to chondrocyte delivery.

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How to Talk to Patients About MACI Knee Cartilage Repair

How to Talk to Patients About MACI Knee Cartilage Repair

In discussions with your patients on treatment for knee cartilage pain, it's important to share the facts about cartilage damage. Cartilage defects won't heal on their own and often worsen over time. Early treatment can lead to improved results.

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Indication

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

MACI is intended for autologous use and must only be administered to the patient for whom it was manufactured. The implantation of MACI is to be performed via an arthrotomy to the knee joint under sterile conditions.

The amount of MACI administered is dependent upon the size (surface in cm²) of the cartilage defect. The implantation membrane is trimmed by the treating surgeon to the size and shape of the defect, to ensure the damaged area is completely covered, and implanted cell-side down.

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.

Important safety information

MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin. MACI is also contraindicated for patients with severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders. MACI is also not indicated for use 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.

MACI is contraindicated in patients who are unable to follow a physician-prescribed post-surgical rehabilitation program.

The safety of MACI in patients with malignancy in the area of cartilage biopsy or implant is unknown. Expansion of present malignant or dysplastic cells during the culturing process or implantation is possible.

Patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases. A cartilage biopsy and MACI implant may carry the risk of transmitting infectious diseases to healthcare providers handling the tissue. Universal precautions should be employed when handling the biopsy samples and the MACI product.

Final sterility test results are not available at the time of shipping. In the case of positive sterility results, health care provider(s) will be contacted.

To create a favorable environment for healing, concomitant pathologies that include meniscal pathology, cruciate ligament instability and joint misalignment, must be addressed prior to or concurrent with the implantation of MACI.

Local treatment guidelines regarding the use of thromboprophylaxis and antibiotic prophylaxis around orthopaedic surgery should be followed. Use in patients with local inflammations or active infections in the bone, joint, and surrounding soft tissue should be temporarily deferred until documented recovery.

The MACI implant is not recommended during pregnancy. For implantations post-pregnancy, the safety of breast feeding to infant has not been determined.

Use of MACI in pediatric patients (younger than 18 years of age) or patients over 65 years of age has not been established.

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.

Please see Full Prescribing Information for more information