FDA Clears New Bone-Graft Substitute for Fusion
Walter Eisner • Wed, June 7th, 2017
Another bone graft substitute for postero-lateral spinal fusion has been cleared by the FDA.
On June 1, 2017, New Jersey-based Prosidyan, Inc., announced the FDA clearance to market the company's FIBERGRAFT BG Putty, the second generation of the company's proprietary fiber-based bioactive glass products.
The company stated the putty "leverages the direct connectivity of fibers with an exponentially increased surface area and optimized resorption rates delivered using Prosidyan’s proprietary bioactive carrier, OSSIGLIDE."
The putty, according to the company, is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be "gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process."
The product must be used with autograft in the posterolateral spine. The putty is not indicated for use in load-bearing applications; therefore, says the company, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
Bioactive glass, according to the company, is a group of glasses which has a compositional range that allows the formation of hydroxyapatite (HA) as a surface layer when exposed to an aqueous phosphate containing solution such as simulated body fluid. The HA layer that forms in an aqueous phosphate containing solution plays a significant role in forming a strong bond with natural bone.
The company says bioactive glass has an "established history of bone bonding that occurs as a result of a rapid sequence of reactions on its surface when implanted into living tissues." When hydrated, a layer of silica gel forms on the surface of the bioactive glass. The adhesion of amorphous calcium, phosphate, and carbonate ions to the silica surface leads to an eventual crystallization of a bone-like hydroxyapatite (HA) as early as 24 hours.
Click here to watch an animation from the company's website on how fiberglass works with bones.
Babak Barcohana, M.D., of the Southern California Orthopedic Institute says he has had "outstanding clinical results" with the putty over the last three years and looks forward to continuing clinical success with this next generation product from Prosidyan.
Stephen Tolhurst, M.D. of the Texas Back Institute said the product is backed by "great science and pre-clinical results. It is the only synthetic bone graft I feel comfortable using without mixing with bone marrow aspirate, making it easy to use in surgery.”
Brian Kwon, M.D. of New England Baptist Hospital called the putty, "The most intelligent bone graft on the market and your best bone graft decision in the OR."
The company was founded in 2009 to develop a family of synthetic bioactive bone graft substitutes based on microscopic fibers of bioactive glass.
Prosidyan’s first product, FIBERGRAFT BG Morsels, a synthetic bone graft substitute, received FDA clearance in March 2014, and the first surgery utilizing this innovative bone substitute was performed in May 2014.
The company’s second product in the line, FIBERGRAFT BG Putty, received FDA clearance in March 2015, and comprises FIBERGRAFT BG Morsels delivered through Prosidyan’s proprietary bioactive carrier, OSSIGLIDE.
To date, says the company, FIBERGRAFT products have been implanted in over 7,000 patients across the U.S. The company believes it "is poised to revolutionize synthetic bioactive bone graft options, with numerous patents and a robust pipeline of products in late stages of development."