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Medtronic plc announced U.S. Food and Drug Administration (FDA) approval of Infuse(TM) Bone Graft in new spine surgery indications. InfuseBone Graft is now approved for use with additional spine implants made of polyetheretherketone (PEEK) in oblique lateral interbody fusion (OLIF 25(TM) and OLIF 51(TM)) and anterior lumbar interbody fusion (ALIF) procedures at a single level. This is the second expanded indication in just over two years.
The new approved indications for InfuseBone Graft are:
- Use in OLIF 51 procedures with Divergence-L®Interbody Fusion Device at a single level from L5-S1.
- Use in OLIF 25 procedures with Pivox(TM) Oblique Lateral Spine System at a single level from L2-L5.
- Use in ALIF procedures with Divergence-LInterbody Fusion Device at a single level from L2-S1.
“Different spine patients can have very different surgical needs, so the more options surgeons have to combine a clinically-proven bone grafting technology like Infuse with different procedures and implants, the greater the likelihood of successful outcomes,” said Dr. Richard Hynes, president and spine surgeon at the B.A.C.K. Center in Melbourne, Florida. “This latest approval addresses some fairly common degenerative spine surgical correction needs.”
InfuseBone Graft is used with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease. This condition can cause back and/or leg pain, as well as functional problems, such as tingling or numbness in the legs or buttocks or difficulty walking.
“Infuse Bone Graft remains one of the most-extensively studied products in Spine that is commercially available today,” said Doug King, senior vice president and president of Medtronic’s Spine division, which is part of the Restorative Therapies Group at Medtronic. “The expanded approval with these PEEK devices for OLIF25, OLIF51, and ALIF procedures provide important options for surgeons and their patients.”
InfuseBone Graft is approved for certain spine, oral-maxillofacial and orthopedic trauma surgeries. Infuse has been on the market since 2002 and has been used in more than one million patients worldwide.
The active ingredient in InfuseBone Graft is rhBMP-2 – a manufactured version of a protein already present in the body that promotes new bone growth. During surgery, it is applied to an absorbable collagen sponge (ACS). The ACS is a carrier to deliver the rhBMP-2 to the implant site and acts as a scaffold for the formation of new bone, and it will resorb, or disappear, over time.
The Divergence-LInterbody Fusion Device and the Pivox Oblique Lateral Spine System incorporate the technology of Gary K. Michelson, M.D.
For Further Information
More on the orthopedic biomaterials market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Orthopedic Biomaterials. This report covers the following market segments: bone graft substitutes (which is represented by allografts, demineralized bone matrix, and synthetic bone grafts), orthopedic growth factors, cellular allografts, orthopedic cell therapy, hyaluronic acid viscosupplementation, orthopedic cartilage repair and spinal machined bone allografts.
The iData series on the market for orthopedic biomaterials covers the U.S. and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about orthopedic biomaterials market data or procedure data, register online or email us at [email protected] for an U.S. Market Report Suite for Orthopedic Biomaterials brochure and synopsis.