HEALTHFIX MEDICAL PRODUCTS LLC
MIAMI, FLORIDA

is CONTRAINDICATED in the presence of one or more of the following clinical situations: untreated acute infections at the surgical site; untreated malignant neoplasm(s) at the surgical site; patients with a known hypersensitivity to any product component (ß-TCP or rhPDGF-BB); intraoperative soft tissue coverage is required for a given surgical procedure but such coverage is not possible; or conditions in which general bone grafting is not advisable. has also not been studied in situations where it would be augmenting autogenous bone and other bone grafting materials; in pregnant and nursing women. It is not known whether rhPDGF-BB is excreted in the milk of nursing women; in pediatric patients below the age of 18 years; in patients with teeth exhibiting mobility of greater than Grade II or a Class III furcation; in patients with frequent or excessive use of tobacco products. Careful consideration should be given to alternative therapies prior to performing bone grafting in patients: who have severe endocrine-induced bone diseases (e.g. hyperparathyroidism); who are receiving immunosuppressive therapy; or who have known conditions that may lead to bleeding complications (e.g. hemophilia). contains becaplermin – a recombinantly produced, human platelet-derived growth factor, homodimer BB (rhPDGF-BB), which is a protein that has been shown to promote the formation of bone in periodontal defects. rhPDGF-BB (“PDGF”) is also the active ingredient of another FDA approved product, REGRANEX® Gel, which is a topical gel formulation, indicated for the treatment of lower extremity diabetic neuropathic ulcers.