CartiHeal Agili-C Implant

Overview

Agili-C is a single-stage, cell-free, off-the-shelf cartilage scaffold, and it holds an FDA indication no other cartilage implant has: use in a knee that already has mild-to-moderate arthritis. Dr. Raffo uses it for patients whose defect and arthritis grade fit that labeled window. The 2-year trial data is strong; longer-term data is still limited, and he says so plainly.

How Dr. Raffo Performs This Procedure

Agili-C is implanted in a single stage, without the biopsy-and-culture sequence that MACI requires. The defect is prepared to accept the implant, and the off-the-shelf aragonite scaffold — a bi-phasic design with a cartilage-facing layer of aragonite and hyaluronic acid — is sized and press-fit into place (Smith+Nephew Agili-C reimbursement guide). Because the scaffold is cell-free and resorbable, there is no separate cell-harvesting procedure or waiting period before implantation, unlike MACI's two-stage structure (FDA — MACI, for comparison).

Who Is This For?

Agili-C's verbatim FDA indication is "the treatment of an International Cartilage Repair Society (ICRS) 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)" (FDA PMA P210034). That single line is the reason this implant exists as a distinct option: it is the only FDA-approved cartilage-repair implant whose label permits use in a knee with radiographic osteoarthritis, up to and including KL grade 3. KL grade 4, meaning severe arthritis, is excluded (FDA PMA P210034). The pivotal trial further specified eligibility of age 21-75, up to 3 lesions, bony defect depth of 8 mm or less, BMI of 35 or less, and malalignment of no more than 8 degrees varus or valgus (FDA SSED P210034b). Agili-C is not appropriate for a knee with severe, bone-on-bone arthritis, nor for a lesion larger than the 7 cm² labeled ceiling.

Recovery & Rehabilitation

Agili-C's single-stage, cell-free design allows for a recovery protocol that does not carry the biopsy-to-implantation delay inherent to MACI.

• 0–6 weeks: Protected weight-bearing while the scaffold begins to integrate.
• 6–12 weeks: Progressive weight-bearing and range-of-motion advancement.
• 3–6 months: Return to low-impact activity for most patients, guided by individual healing.
• 24 months: The trial's primary endpoint window, where MRI showed 75% or greater defect fill in 88.5% of Agili-C patients versus 30.9% of standard-of-care patients (Altschuler et al. 2023).

Biologics Used