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Innovasis Landmark Study on Spinal Fusion Published in Top Spine Journal

Salt Lake City, Utah, August 22, 2024 – OrthoSpineNews

Innovasis, a leading innovator in bioactive spine surgery solutions, is proud to announce the publication of a landmark study in the International Journal of Spine Surgery. The study, titled “Interim 1-Year Radiographic and Clinical Outcomes Following Anterior Cervical Discectomy and Fusion Using Hydroxyapatite-Infused Polyetheretherketone Interbody Cages,” highlights the significant advancements and positive outcomes associated with Innovasis’ HA-PEEK (Hydroxyapatite-Infused Polyetheretherketone) interbody cages.

The study utilized data from the BioBase® Data Registry, a comprehensive, multicenter observational registry managed by a third party, which tracks patient outcomes and supports the development of advanced spine surgery technologies. A multicenter research team from the Hospital for Spine Surgery, Georgetown University and other national sites, analyzed the efficacy and safety of HA-PEEK cages in anterior cervical discectomy and fusion (ACDF) procedures in 789 patients. The results demonstrate the efficacy and safety of HA-PEEK cages in anterior cervical discectomy and fusion (ACDF) procedures.

  • A fusion rate of 91.3% at 6 months and 92.2% at 12 months postoperatively.
  • Significant improvements in patient-reported outcomes, including Neck Disability Index (NDI) and visual analog scale (VAS) scores for neck and arm pain.
  • High patient satisfaction rates, with over 95% of patients reporting satisfaction from 6 weeks to 12 months postoperatively.
  • A very low revision rate of 0.2%, underscoring the safety and reliability of HA-PEEK cages.

ACDF with HA-PEEK cages demonstrated promising radiographic and clinical outcomes in a large unrestricted patient cohort, supporting real-world evidence and incorporating HA into PEEK cages to enhance fusion rates and improve patient outcomes. Ongoing longitudinal studies will be conducted to evaluate HA PEEK among other challenging cohorts, within the same population.

Innovasis is a market leader in the development and manufacturing of spinal implant devices and related surgical instruments. Based in Salt Lake City, UT, Innovasis is committed to providing innovative solutions that improve patient care and outcomes in spinal surgery.

The BioBase® Data Registry is a multicenter, observational registry designed to monitor and measure patient outcomes following spinal surgery. It serves as a valuable resource for ongoing research and development efforts in the space, ensuring that product efficacy and patient safety remain at the forefront.

Published Journals:

https://www.ijssurgery.com/content/18/2/122

https://journals.sagepub.com/doi/full/10.1177/21925682231223117

Contact Information

For more information about The BioBase® Registry or to participate in the program, please contact info@innovasis.com

Tim Allen

Medtech leader with 19+ years of experience in medical device product development, manufacturing, and project management.

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