A single-stage, off-the-shelf solution for knee cartilage and osteochondral defects, with or without mild to moderate osteoarthritis (KL 0-3) comprised of a proprietary biomaterial that is porous and biocompatible.
Derived from a naturally occurring calcium carbonate known as aragonite, the CARTIHEAL Implant is a biphasic scaffold for cartilage repair and subchondral bone restoration.
Shown to deliver clinically meaningful improvements in pain, function and quality of life,*4,5 the CARTIHEAL Implant is the only device approved for the treatment of knee cartilage and osteochondral defects in patients with or without mild to moderate osteoarthritis (KL 0-3).1
The CARTIHEAL Implant is designed to help the body repair knee cartilage and restore damaged bone;2-5 shown to be largely resorbed by the body within 18 months.3,4,6
Explore the surgical technique steps, chondral/osteochondral knee indications, supporting surgeon videos and clinical guides.
To learn more about our S+N Sports Medicine portfolio, please visit our Knee Repair Page on VuMedi.
Rx only
Treat articular cartilage and/or osteochondral defects.
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).
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.
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.
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.
* Over 2 and 4 yr follow-up; standard of care = microfracture or debridement.
** Illustration only; not an actual representation.
Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Smith+Nephew representative or distributor if you have questions about the availability of Smith+Nephew products in your area.
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