AUGMENT® Injectable - P100006/S005
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: AUGMENT® Injectable
PMA Applicant: Biomimetic Therapeutics, LLC a wholly owned subsidiary of Wright Medical N.V.
Address: 389 Nichol Mill Lane, Franklin, Tennessee 37067
Approval Date: June 12, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100006S005a.pdf
What is it? AUGMENT® Injectable is a combination product composed of two device components and one drug component. It is indicated for use as an alternative to using a patient's own tissue (autograft) in arthrodesis (i.e., fusion procedures) of the ankle and/or hindfoot when supplemental graft material is needed.
AUGMENT Injectable is made up of three parts. The first part consists of granules of a synthetic ceramic bone-like substance called beta-Tricalcium Phosphate (β-TCP). The second part is made from tissue from cow hides (bovine collagen). The third part is a man-made (genetically-engineered) protein called recombinant human platelet-derived growth factor (rhPDGF-BB).
How does it work? β-TCP, the ceramic part of AUGMENT Injectable, provides a scaffold for bone cells to grow on. As bone grows, the ceramic part is gradually replaced by the new bone.
The bovine collagen part of AUGMENT Injectable dissolves in the body and is used to help deliver the β-TCP and the rhPDGF-BB to the surgery site. When the collagen component is mixed with the β-TCP and the rhPDGF-BB components, the combination has a toothpaste-like consistency. This allows the physician to apply the AUGMENT Injectable directly to the surgery site using a syringe.
The drug component of AUGMENT Injectable, rhPDGF-BB, is a man-made (genetically-engineered) protein (growth factor) found naturally within blood cells (platelets). When the body is injured, PDGF-BB is released from the platelets as part of the natural healing process. The rhPDGF-BB used in AUGMENT Injectable works in a similar way as PDGF in the body by attracting cells and helping them repair and grow new bone.
When is it used? AUGMENT Injectable is intended for use as an alternative to autograft in arthrodesis (i.e., fusion procedures) of the ankle and/or hindfoot in patients with osteoarthritis, post traumatic arthritis, rheumatoid arthritis, psoriatic arthritis, avascular necrosis, joint instability, joint deformity, congenital defect, or joint arthroplasty. It is intended for patients who need supplemental graft material.
What will it accomplish? AUGMENT Injectable was shown in clinical studies to be at least as effective as an autograft control treatment in relieving pain and improving functional abilities. In addition, the use of AUGMENT Injectable eliminates the need for a second surgery to acquire the patient's bone, thereby avoiding the risks associated with collecting the bone, such as pain or infection at the donor site.
The safety and effectiveness of AUGMENT® Injectable were tested in a total of 299 patients undergoing foot and/or ankle fusion in a number of hospitals in the US and Canada. Patients were divided into two groups – the experimental group received AUGMENT® Injectable (132 patients) and the control group received their own bone (167 patients). Subjects were randomly treated with either AUGMENT® Injectable or their own bone. The study included evaluations of pain and function at multiple timepoints. These results showed that AUGMENT® Injectable was at least as effective as autograft for treating the patient's pain and improving the patient's function.
When should it not be used? AUGMENT® Injectable should not be used:
- in patients who have a known hypersensitivity to any of the components of the product, or who are allergic to yeast or bovine collagen-derived products.
- in patients with active cancer.
- in patients who are skeletally immature (less than 18 years of age or no radiographic evidence of closure of the growth plates in long bones (epiphyses).
- in pregnant women. The potential effects of rhPDGF-BB on the human fetus have not been evaluated.
- in patients with an active infection at the operative site.
- in situations where soft tissue coverage is not achievable.
- in patients with metabolic disorders known to adversely affect the skeleton (e.g. renal osteodystrophy or hypercalcemia), other than primary osteoporosis or diabetes.
- as a substitute for structural graft.
Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data (SSED) and labeling are available at: