Surgical Best Practices for a Knee Arthroscopy and MACI Cartilage Biopsy
Important Safety Information
Full Prescribing Information
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Surgical Best Practices for a Knee Arthroscopy and MACI Cartilage Biopsy

The first step in treating knee cartilage damage via MACI is an arthroscopy. The knee arthroscopy allows a physician to scope the knee and harvest a biopsy of a patient’s cartilage cells, which are later used to generate a MACI knee cartilage implant.

Since ACI’s inception in 1987, surgeons have developed tried and true techniques for the initial arthroscopy and biopsy collection.

An arthroscopy to survey knee damage and harvest a MACI biopsy.

Review our three-part online seminar series “Work of Arthroscopy” for guidance on optimizing the procedure for positive patient outcomes.

The following practices do not constitute medical advice, and patients should be assessed according to their unique circumstances.

 

 

Session 1: Why Staged Treatment of Cartilage is Right for Your Patient?

Art of Arthroscopy: Why Staged Treatment of Cartilage is Right for Your Patient?

Get an intro to MACI knee cartilage repair hosted by Dr. Paul Caldwell. It will cover:

  • Insight into the MACI process and its potential benefits
  • How to talk to patients about cartilage treatment options without causing fear
  • Information on the MACI insurance approval process
  • A profile of the patient who may consider MACI knee cartilage repair

REQUEST A WEBINAR – Session 1: Art of Arthroscopy

 

 

Session 2: Find Guidance for Intra-Articular Knee Evaluation and Biopsy

Art of Arthroscopy: Find Guidance for Intra-Articular Knee Evaluation and Biopsy

Dr. Scott Gillogly walks us through best practices for the arthroscopy procedure including:

  • Basic instruments and set up of the arthroscopy
  • His approach to the arthroscopic survey of the knee
  • Criteria to identify knee cartilage lesions appropriate for MACI
  • Appropriate biopsy harvest sites
  • Cartilage sample harvest techniques using arthroscopic instruments such as a ring curette and a notchplasty gouge

REQUEST A WEBINAR – Session 2: Art of Arthroscopy

 

 

Session 3: The “What Ifs”: Considerations in the Planning of Articular Cartilage Restoration

Art of Arthroscopy: Find Guidance for Intra-Articular Knee Evaluation and Biopsy

Dr. Wayne Gersoff covers various complicating knee pathologies physicians encounter during an arthroscopy and how you can address them. Learn your options for scenarios including:

  • Patellofemoral instability
  • ACL deficiency
  • Bone deficiency
  • Meniscal injury
  • Bone marrow edema
  • Altered knee environment

REQUEST A WEBINAR – Session 3: Art of Arthroscopy

 

Please see below for full indication and ISI.

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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.