CARTICEL: Pre-Biopsy

Pre-Biopsy

Prior to the biopsy that is necessary to initiate CARTICEL^®production, you must obtain a Cartilage Biopsy Transport Kit from Genzyme Biosurgery. This kit is intended for storage and transport of cartilage biopsy for the preparation of CARTICEL and provides the necessary nutrients and temperature control required to maintain the patient’s tissue sample during transportation from the hospital or surgery center to Genzyme Biosurgery’s facilities in Cambridge, Massachusetts.

To order a Cartilage Biopsy Transport Kit, contact Genzyme Biosurgery Customer Care at 800-453-6948, or your local Clinical Account Executive. To have a Clinical Account Executive contact you, please submit your request via the Request Information form.

The Cartilage Biopsy Transport Kit is delivered to the location you specify by a common carrier service, such as Federal Express.

Please call a Genzyme Biosurgery representative at 800-453-6948, Option #1 for specific instructions on biopsy handling and return shipment of the biopsy to Genzyme Biosurgery, or submit a request to have a representative contact you.

CARTICEL is for autologous use and is indicated for the repair of symptomatic, cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft). CARTICEL should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. It is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis. It is not recommended for patients whose knee meniscus has been surgically removed unless the patient has undergone surgical reconstruction prior to or concurrent with CARTICEL implantation.

Pre-existing conditions including meniscal tears, joint instability or malalignment of the joint should be corrected prior to or concurrent with CARTICEL implantation. It should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin. CARTICEL is not routinely tested for transmissible infectious diseases and may transmit disease to the healthcare provider handling CARTICEL. In addition, it should not be used in patients who have previously had cancer in the bones, cartilage, fat or muscle of the treated limb. Use in children, patients over age 65, or in joints other than the knee has not yet been assessed.

The occurrence of subsequent surgical procedures (SSPs), primarily arthroscopy, following CARTICEL implantation is common. In the Study of the Treatment of Articular Repair (STAR), forty-nine percent (49%) of patients underwent an SSP on the treated knee, irrespective of their relationship to CARTICEL, during the 4-year follow up. The most common serious adverse events (³ 5% of patients), derived from STAR, include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion, graft delamination, and osteoarthritis.

For more information on CARTICEL, please see the Package Insert (PDF).