An Massachusetts Institute of Technology (MIT) research team that may have found a way to make bone implants less likely to fail using a high-tech adhesive that more securely bonds implants to bone by promoting cell growth between natural and artificial body parts. In a study published in the June 26 online edition of Science Translational Medicine, the MIT team and its collaborators from several other institutions reported that the implant adhesive — a multilayered coating of ceramic and nanolayers
The Wall Street Journal is reporting that Medtronic`s `Infuse Bone Graft` has been linked to life-threatening complications in dozens of patients. The FDA warned surgeons in July that it had received reports of life-threatening complications associated with using the product in surgeries on the cervical spine, around the neck. The agency said it received 38 reports over four years of side effects, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in
Novalar has developed NV101, a novel compound that is the only local anesthetic reversal agent that accelerates the return to normal sensation and function following restorative and periodontal maintenance procedures. Novalar has contracted with the leading North American supplier of dental anesthesia cartridges to manufacture NV-101. NV-101 treated patients reported the return of sensation and function in less than half the time it normally took after receiving local dental anesthesia. NV-101 induced a 54.8 percent and a 62.3 percent decrease
Osteohealth`s GEM 21S is a wound healing and bone regeneration technology termed growth-factor enhanced matrix (GEM). It has recently become available for clinical use. This graft material consists of a concentrated solution of pure recombinant human platelet-derived growth factor (rhPDGF-BB), the synthetic form of the body’s key natural wound healing stimulator PDGF-BB, and an osteoconductive (bone scaffold) matrix. This is the first available purified, recombinant (synthetic) growth factor product and is the result of over a decade of extensive research.
In the course of a routine inspection of Biora AB, Straumann`s oral regenerative product company in Sweden, in October 2006, a U.S. Food and Drug Administration (FDA) investigator made a number of observations predominantly concerning maintenance of quality system documentation and procedures associated with the company`s products. Biora has received a “warning letter“ from the FDA, which indicated that its “dental bone grafting materials“ are on import detention in the U.S., until the inspectional observations are resolved. No other countries
Medtronic recently announced that the FDA Dental Products Advisory Panel has unanimously voted to recommend approval, with a condition the use of INFUSE® Bone Graft for certain oral and maxillofacial bone grafting procedures. INFUSE Bone Graft is recombinant human bone morphogenetic protein-2 (rhBMP-2) applied to an absorbable collagen sponge carrier. The purpose of the protein, which occurs naturally in the body, is to stimulate bone formation. It has been previously approved by the FDA for use in certain lumbar spine