CARTIHEAL^◊ AGILI-C^◊ Cartilage Repair Implant

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

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

INTENDED USE

Treat articular cartilage and/or osteochondral defects.

INDICATIONS

The CARTIHEAL AGILI-C Implant is indicated for treatment of articular cartilage and/or osteochondral defects in patients who suffer from chondral or osteochondral lesions of the knee.

CONTRAINDICATIONS

CARTIHEAL AGILI-C Implant 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 surgical site or treated joint; Severe Osteoarthritis of the index knee, defined as grade 4 according to the Kellgren-Lawrence Grading (specific to knee joint procedures); 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 CARTIHEAL 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; The implant has not been tested in patients with osteoporosis; Osteoporosis may impact a patient’s ability to integrate the implant and to biodegrade it while forming a new bone; Exercise caution in use in patients with osteoporosis; Chemotherapy during the past 12 months; Ligamentous instability; Significant malalignment (specific to knee joint procedures); Total or subtotal meniscectomy or lack of functional meniscus (specific to knee joint procedures); The implant is not indicated for treatment in patients with inflammatory arthropathy or crystal-deposition arthropathy; Skeletally immature – do not implant the device through the epiphyseal plate (growth-plate); Inability to refrain from contact sports or other high-impact activities for the recommended recovery period; Noncompliance due to major psychiatric disorder, alcohol or drug abuse; Skin conditions within the field of surgery, such as psoriasis.

ADDITIONAL WARNINGS

The implant should not be implanted through arthroscopic approach. The Agili-C™ should be implanted through arthrotomy or mini-arthrotomy approach; The implant is not indicated for treatment in Patellar cartilage and osteochondral defects; Use the device according to the provided instructions; The contents of this package are for single use only; Do not re-sterilize; Do not use the device after the expiration date; If package is damaged, and sterile barrier is not intact, do not use and return the damaged item to CartiHeal/Smith+Nephew; Open the package carefully to prevent implant damage; Inspect the implant prior to use and do not use the implant if broken; This device can only be used by a qualified orthopedic surgeon. It is the surgeon’s responsibility to be familiar with the appropriate surgical technique prior to using this device; Agili-C™ should be exclusively implanted using its designated surgical tool set. Using any other implantation system may lead to improper device positioning and may cause implant breakage and/or malfunction; Creation of an improper implantation site may lead to implant breakage, instability, implant loosening and device failure;The defect site must exhibit vital bone on its entire circumference otherwise implant integration may not occur; The surgeon must take into consideration the joint geometry especially close to the condyle notch, lateral lesions, and trochlear lesions. If there is a chance of bone wall violation during creation of the implantation site, the implant should not be used; The implant must be inserted into the defect in a press fit manner. Non-press fit positioning may lead to failure due to lack of implant integration; In case of multiple implants, do not place the devices in an overlapping manner; it is important to keep a bone bridge of at least 5 mm between any two proximal implants to ensure the entire circumference of each implant is in direct contact with the bone, and that the implants are not impinging on each other; It is not advisable to apply the device by means of mosaicplasty technique (i.e., kissing implants); The implant should be positioned 2mm recessed relative to the articular surface; Protruding implants may lead to procedure failure; If the implant is inserted at or above the articular cartilage, damage to the counter or adjacent tissue can occur, as well as particulate debris generation and synovitis; Protruding edges of the implant above the articular surface, may lead to implant breakage and/or injury of nearby tissue. It is required that all implant sharp edges be removed; Implant fragments or particulate debris can cause synovitis and may lead to damage may cause an inflammatory response; In case of a need of intra-operative revision, remove an implant, and use a new implant of the same size or larger. Do not re-implant the removed implant; Avoid entrapment of soft tissue between the implant and the bone which may lead to penetration of synovial fluid, formation of cyst around the implant and lack of integration; In case of implant breakage or cracks, remove the implant and use a new one. Do not leave a cracked, fragmented or broken implant in the joint. After removal, dispose of the implant in accordance with acceptable medical practice and applicable local and national requirements; In case of implant removal, carefully remove all remnants and wash the joint intensively. Implant particles, if left in the joint, can cause synovitis and may lead to damage; The device is composed of a porous brittle material, applying excess mechanical pressure during insertion may lead to implant breakage and particles generation; Do not use excess force during implant insertion; Do not use hammer or any other mechanical instruments for implant insertion, besides the designated Tamper provided in the surgical toolset.

PRECAUTIONS

The Agili-C™ implant is a biphasic scaffold. The implant surface with the drilled channels is the implant top and faces the articular surface. The tapered side, without the drilled channels, is the implant bottom and faces the bone. Before implanting the device, pay attention to the side to be placed in contact with the bone. Incorrect orientation of implant positioning may lead to improper healing; Incorrect use of the surgical toolset can lead to bone breakage, damage to neurovascular structures, bone cyst formation, implant breakage or improper implantation and/or site creation; Implantation within avascular necrosis or cyst may lead to lack of implant integration and implant failure; Entrapment of soft tissue between the implant and the bone during implantation may lead to small gap followed by penetration of synovial fluid, lack of integration and cyst formation; High impact or extreme shear forces on the implantation site during recuperation period, as results of trauma or sports activities, can lead to implant breakage and revision; Post-surgical ambulation should follow the physician recommended rehabilitation regime in order to avoid extreme forces during the recuperation period.

ADVERSE REACTIONS

Possible adverse reactions during the post-operative phase include, but are not limited to:

Transient or chronic pain, including complex regional pain syndrome; Transient or chronic swelling and/or effusion of the operated joint; Transient or chronic synovitis; Transient or chronic joint locking and/or limited range of motion, stiffness and arthrifibrosis; Fever; Bone marrow edema; Allergic or pseudo-allergic reaction and/or elevation of acute phase reactants; Pseudo septic reaction; Reactive arthritis; Aseptic arthritis; Bone cyst; Bone fracture; Bone deformity; Osteophyte formation; Development or progression of osteoarthritis; Formation of new cartilage or osteochondral defects, or worsening of current lesions; Bone aseptic or avascular necrosis; Implant fracture, loosening or extrusion, with or without generation of particulate debris; Abrasion of counter or nearby tissues; Failure to induce tissue regeneration; Tissue formation deficiencies, lack of new tissue formation; Partial ingrowth, overgrowth, fibrous tissue ingrowth or partial coverage of the implant; Ligament laxity; Damage to meniscus; Joint deformation; Tissue hypertrophy or inter-lesional bone formation or inter-lesional osteophytes; Wound complications; Hematoma, hemathrosis or site drainage; Superficial or deep infections; Septicemia; Wound dehiscence; Intra-articular adhesions, hypertrophic tissue, hypertrophic synovitis or host reactions; Inflammation of the joint and surrounding tissues; Deep Vein Thrombosis; Infection, including local and general complications; Elevation of the subchondral bone plate; Degeneration of the surrounding cartilage; Lack of cartilage or implant integration; Delamination; Muscle atrophy.

For detailed product information, including indications for use, contraindications, precautions and warnings, please consult the product’s applicable Instructions for Use (IFU) prior to use.