INFUSE® Bone Graft - P000054
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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: INFUSE® Bone Graft
Applicant: Wyeth Pharmaceuticals
Address: P.O. Box 8299 Philadelphia, Pennsylvania 19101-8299
Approval Date: April 30, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p000054a.pdf
What is it? The INFUSE® Bone Graft device is used along with an intermedullary nail (IM nail) to help heal fractures of the lower leg bone (tibia).
The INFUSE® device consists of two parts:
- a genetically-engineered human protein (rhBMP-2) to stimulate bone healing, and
- an absorbable collagen sponge made from cow (bovine) collagen that is soaked with the protein.
How does it work?
- A metal rod, called an intermedullary nail or IM nail, is surgically implanted inside the tibia bone to stabilize the fracture.
- The INFUSE ® device is implanted at the fracture site to help the bone heal.
When is it used? The INFUSE ® device is intended to be used along with internal stabilization (an IM nail) to help heal a fresh, open fracture of the tibia.
What will it accomplish? In a clinical study, use of the INFUSE® device caused fractures to heal in a similar manner to bones not treated with the device. Patients who received INFUSE® required fewer interventions to promote healing compared to patients who did not receive the device. However, patients who received the device and required an intervention healed at a slower rate compared to patients who did not receive the device.
When should it not be used? The INFUSE® Bone Graft device should not be used in patients who:
- are pregnant or suspect that they might be pregnant;
- are sensitive to titanium, titanium alloy, cow (bovine) Type I collagen or recombinant human Bone Morphogenetic Protein-2 (rhBMP-2);
- have an infection near the area of the surgical incision;
- have had a tumor removed from the area of the implantation site or currently have a tumor in that area;
- have a high risk of amputation of the affected leg; or
- have compartment syndrome (increased pressure in a muscle group causing a decrease in blood flow) of the affected leg.
Precautions and Warnings:
The INFUSE® Bone Graft has not been tested in patients:
- who are women of child-bearing age;
- who are nursing mothers;
- who have the device implanted more than once;
- with liver or kidney problems, because these organs are involved in removing any byproducts of the device;
- with metabolic bone diseases, such as osteoporosis;
- with autoimmune or immunosuppressive diseases, such as AIDS or lupus; or
- with an immune deficiency due to other treatments, such as radiation therapy, chemotherapy or steroid therapy.
The INFUSE® device has not been studied in enough patients 65 years and older to determine whether they respond differently to the device than younger patients.
Although not seen in any clinical studies performed by the manufacturer, there is a possibility that too much bone may form at the implantation site, bone may form at a location away from the implantation site or the bone that forms may be abnormal.
Some patients may have an allergic reaction to this device.
Please talk with your doctor if you have questions about any of the above warnings and precautions.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p000054