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SurGenTec’s OsteoFlo HydroFiber bone graft approved for spinal surgeries

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SurGenTec announced that OsteoFlo HydroFiber, its synthetic bone graft solution equivalent to autograft, is now being used in spinal surgeries following FDA 510(k) clearance. The milestone marks an advancement in bone graft technology, as OsteoFlo HydroFiber is recognized as a stand-alone solution equivalent to autograft for spine surgeries, including use in interbody fusion cages, disc spaces and posterolateral fusions.

Game-changing technology

OsteoFlo HydroFiber leverages Web Interlace Technology, suspending particles within its fibers to prevent graft migration while ensuring optimal cohesiveness and flowability. The product employs hydrophilic bonds and proprietary fibers that absorb saline, blood or bone marrow aspirate while establishing a robust platform to support healing.

The graft can also be used with SurGenTec’s Graftgun delivery device for efficiently backfilling interbody cages, offering an improvement over traditional funnel methods.

Safer, smarter solutions for surgeons and patients

By eliminating the need for autograft harvesting, OsteoFlo HydroFiber minimizes surgical time and reduces patient recovery challenges. Unlike allograft-based solutions, it removes risks associated with donor variability, disease transmission and storage complications.

“OsteoFlo HydroFiber provides a novel, customizable solution for surgeons, tailored to both anatomy and procedure type,” said Travis Greenhalgh, CEO and founder of Boca Raton, Fla.-based SurGenTec. “Physicians are familiar with the handling characteristics of fiber-based allograft products, and we are proud to introduce a synthetic option designed to enhance bone healing without the risks associated with human allograft tissue.”

Industry recognition and future impact

OsteoFlo HydroFiber received the 2024 Spine Technology Award, presented by Orthopedics This Week at the North American Spine Society conference.

Dr. Ashish Patel, chairman of spine surgery at Downers Grove, Ill.-based Duly Health and Care, expressed enthusiasm for the technology, stating, “HydroFiber represents the next generation of bone graft solutions, delivering unmatched performance without the risks commonly associated with cellular allografts.”

Dr. Micah Smith of Ortho NorthEast echoed this sentiment, saying, “This innovative solution marks a significant advancement in the field, demonstrating performance that matches or exceeds autografts in both posterolateral gutters and interbody spaces. The fiber component enhances flowability and cohesion, preventing migration and ensuring the graft remains precisely where it is placed.”

Looking ahead

SurGenTec remains dedicated to developing and manufacturing products for orthopedic and neurosurgical procedures. The company continues expanding its portfolio of surgical solutions to improve patient care.

For more information about OsteoFlo HydroFiber and SurGenTec’s latest advancements, visit www.SurGenTec.com.

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