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Xtant Medical Holdings, Inc., a leader in the development of regenerative medicine products and medical devices, recently announced that the U.S. Food and Drug Administration (FDA) has cleared the Xsert Lumbar Expandable Interbody System.
The Xsert System is an all titanium expandable interbody device that expands in-situ. It is available in various sizes and lordotic angulations to fit the most complex anatomical needs of patients. These spacers are designed to simplify surgeon insertion technique[s] while offering implant height adjustability. Osteointegration will be encouraged through nanotextured endplate surfaces as well as central and lateral implant graft windows. The system is intended for use at one or two contiguous levels (L2-S1 inclusive).
Xsert is also cleared to be packed with autograft or allograft bone graft. Xtant Medical’s 3Demin and patented OsteoSponge technology are excellent allografts to use with Xsert due to their ability to compress, fill and expand in the device’s graft chamber, allowing for ideal bone contact and fusion.
“We are very pleased to have received clearance for Xsert. This system allows the surgeon to implant the cage in a tighter corridor and then expand the device according to the patient’s anatomy,” stated Dr. David Kirschman, developer of Xsert and current member of the Xtant Medical Board of Directors. “With the clearance of allograft use with Xsert, Xtant Medical further expands combined device and biologic solutions for surgeons and their patients.”
Xtant Medical estimates the U.S market for lumbar interbody devices at $1.3M and growing. The worldwide market for Demineralized Bone Matrix (DBM) is estimated at $485M. Xsert will be available in an initial product release in mid 2017.
For Further Information
More on the orthopedic stem cell therapy market in the U.S. can be found in the report published by iData entitled U.S. Market for Orthopedic Biomaterials. This report also covers the U.S. market segments for orthopedic bone graft substitutes, orthopedic growth factors, orthopedic stem cell therapy, orthopedic hyaluronic acid viscosupplementations, orthopedic cartilage repairs, and spinal machined bone allografts.
The iData series on the market for orthopedic bone graft substitutes covers the U.S., Japan, South Korea, Australia, China, and 15 countries in Europe. Full reports also 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 U.S. orthopedic biomaterials market data or procedure data, register online or email us at [email protected] for a U.S. Market for Orthopedic Biomaterials report brochure and synopsis.
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About iData Research
iData Research (www.idataresearch.com) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Laparoscopy, Urology, Gynecology, Vascular Access, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Ultrasound, X-Ray Imaging, Diagnostic Imaging, Oncology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large & Small Joints, Anesthesiology, Wound Management, Orthopedics, Ophthalmics, Dental Operatory Equipment and more.
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