Overview
The CARTIHEAL AGILI-C Cartilage Repair Implant is designed to repair damage in the cartilage and bone of the knee, including damage caused by arthritis. Patients treated with the CARTIHEAL AGILI-C Implant have reported significant relief of knee pain and improved knee function.1-2*
CARTIHEAL AGILI-C Implant patient success stories
Learn more through the stories of real patients who have found relief from knee pain with the CARTIHEAL AGILI-C Implant.
The patient testimonial(s) depicted represent the individual patient’s own opinions, findings, beliefs, and/or experiences. Individual results will vary. Not everyone who receives a product or treatment will experience the same or similar results; results may vary depending on a number of factors, including each patient’s specific circumstances and condition, and compliance with the applicable Instructions for Use. Smith+Nephew is not responsible for the selection of any treatment by a healthcare professional to be used on a particular patient. Smith+Nephew makes no representations, warranties, guarantees or assurances as to the availability, accuracy, currency or completeness of the information presented or its contents.
Results will vary. These are representative drawings only, not actual surgical results.
Important safety and risk information
Rx only
INTENDED USE
Treat articular cartilage and/or osteochondral defects.
INDICATIONS FOR USE
The AGILI-C™ scaffold is indicated for the treatment of an International Cartilage Repair Society grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).
CONTRAINDICATIONS
AGILI-C™ should not be implanted in subjects with the following conditions:
Active or latent, bone or joint infection at the surgical site; Active infection elsewhere in the body; Neuropathic joint; Hypersensitive, allergic, or intolerance of materials containing calcium carbonate or coral derivatives; Critical limb ischemia; Any known tumor of the knee area; Severe Osteoarthritis of the index knee, defined as grade 4 according to the Kellgren-Lawrence Grading; Uncontained lesion - lack of vital bone wall, at least 2mm thick, surrounding the implantation site; Subchondral bone defect or bone cyst depth deeper than 8mm; Inability to position the implant 2mm recessed relative to the articular surface; Osteochondral or cystic lesions larger than what the implant can cover; Implantation inside avascular necrosis.
WARNINGS
The safety and effectiveness of the AGILI-C™ Implant has not been established in patients with the following conditions: Morbid obesity (BMI >35); Known insulin dependent diabetes mellitus; Immunocompromised patients; including patients receiving a previous intra-articular steroid injection within the last 1 month; Systemic conditions affecting wound healing; Systemic bone disorder, such as but not limited to, osteoporosis and osteogenesis imperfecta; Chemotherapy during the past 12 months; Ligamentous instability; Significant malalignment; Total or subtotal meniscectomy or lack of functional meniscus; Inflammatory arthropathy or crystal-deposition arthropathy; Skeletally immature; Inability to refrain from contact sports/high-impact activities during recovery period; Noncompliance due to major psychiatric disorder, alcohol or drug abuse; Skin conditions within the field of surgery. The implant is not indicated for treatment in Patellar cartilage and osteochondral defects or for use in other joints.
RISKS AND SIDE EFFECTS
As with any surgical procedure, there are risks you should be aware of to help make your decision. The most common risks that occur with the AGILI-C™ implant include increased transient or chronic pain of the operated joint, increased swelling and/or effusion of the operated joint, decreased range of motion, hemarthrosis and contusion.
In addition to the risks above, there are other risks that may occur. For full product information, including indications for use, contraindications, precautions, warnings and adverse events, please consult the product’s applicable Instructions for Use (IFU) prior to use.
Burn wound management Burn wounds are a global public health problem and a leading cause of morbidity, including prolonged hospitalisation, disfigurement and disability – often accompanied by stigma and social rejection.1 Our aim is to help mitigate the complications associated with burn wounds.
Pressure injury prevention Trusted to reduce the incidence of pressure injuries when used as part of a comprehensive prevention program, compared to standard care alone.1-3
Partial-thickness rotator cuff tears Partial-thickness tears can have a lasting impact on pain and shoulder function. When used in isolated bioinductive repair, the REGENETEN◊ Bioinductive Implant leads to tendon healing without the need for sutured repair;1-4 offering patients a faster recovery and return to activity than sutured repairs.4,5
Chondral and osteochondral knee repair Treat knee cartilage lesions and osteochondral defects in a single-stage procedure, even in the presence of mild to moderate osteoarthritis (Kellgren-Lawrence 0-3),1,2 with the porous, biocompatible CARTIHEAL◊ AGILI-C◊ Cartilage Repair Implant; shown to be clinically superior to the current surgical standard of care in level 1 clinical data.*1,2