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899 Congress Street, Boston, MA 02210
Northeast MACI Fellows Course: Sponsored by Vericel
The course will focus on adult knee cartilage repair treatment options. Attendees will participate in a “What would you do?” case-based discussion around cartilage injuries, and more specifically, MACI and MACI Arthro, including hands-on training.
Course Location:
Five Labs - Seaport | 899 Congress Street, Boston, MA 02210
Intended Audience:
Current Sports Medicine Fellows in the Northeast Region of the US
Accommodations and transportation will be booked and provided by Vericel upon registration
Dress code: Smart/Business Casual; Closed-toe shoes/sneakers for cadaver lab; PPE will be provided
These speakers are compensated by Vericel Corporation. This series is not intended to provide medical advice. Individual results will vary. Financial support for this event page placement was provided by Vericel.
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 physicianprescribed
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.
899 Congress Street, Boston, MA 02210