INDICATION
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.
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.
Restrictions for US HCPs: In compliance with the PhRMA Code on Interactions with Healthcare Professionals, guests and/or spouses will not be permitted to attend. Please note that Vericel is subject to several laws that restrict the provision of food and beverage in connection with an event. In particular, some state and local jurisdictions, such as Vermont, Louisiana and Minnesota, prohibit or limit companies like Vericel from providing food and beverage to HCPs. Please disclose if you are licensed in a state or work in a jurisdiction or facility that limits or prohibits HCPs from partaking in a meal or refreshments. Any HCPs with meal/refreshment prohibitions are required to opt-out as noted on the sign-in form. Vericel is also subject to other federal disclosure laws. Vericel will report the name and value received for all HCPs who receive a meal as required by law. So that we may comply with federal and state disclosure laws, Vericel Corporation requires all practitioners in attendance to sign in. On the sign-in sheet, you have the option to indicate your non-participation in the meal offered in connection with this program. If selected, Vericel Corporation will not report a transfer of value to you.
Restrictions for International HCPs: HCPs from outside of the US may not attend this promotional program about US FDA-approved products.