Press release
Orthofix Announces Presentation of Long-Term Evidence Highlighting the Clinical Management of Cervical Disc Arthroplasty at North American Spine Society Annual Meeting
Data includes results from five-year multi-center IDE study in U.S. of the M6-C disc that also demonstrated strong clinical performance, safety and patient
About this update from Orthofix Medical Inc.
[{"type":"text","content":"\nData includes results from five-year multi-center IDE study in U.S. of the M6-C disc that also demonstrated strong clinical performance, safety and patient benefits\n\n LEWISVILLE, Texas--(BUSINESS WIRE)--\nOrthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced the presentation of long-term evidence highlighting the clinical management of cervical disc arthroplasty during the North American Spine Society (NASS) 2022 annual meeting October 12-15 in Chicago.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221010005216/en/Orthofix M6-C Artificial Cervical Disc (Photo: Business Wire)\n“We are pleased to sponsor the presentation of data supporting the clinical effectiveness of cervical disc arthroplasty including five-year data from our U.S. IDE study,” said Kevin Kenny, Global President of Orthofix Spine. “We are honored to have a distinguished surgeon panel that will provide their insights about cervical disc replacement and long-term outcomes of this therapy for patients suffering from degenerative disc disease.”\n\nThe presentation will be conducted on Wednesday, Oct. 12 at 12:00 pm in the Red Theater located in the Exhibit Hall by Dr. Armen Khachatryan, Dr. Frank Phillips, Dr. Josh Jacobs, Steve Kurtz, Ph.D., and Gunnar Andersson, Ph.D.\n\nHighlights that will be presented include:\n\n\nData recently released from a U.S. IDE study showing that the M6-C™ disc produced statistically significant benefits at five years, including:\n\n\nreduction in disability, with an NDI score of 8.0 – which indicates mild disability compared to 18.0 in the anterior cervical discectomy and fusion (ACDF) group\n\n\nreduction in shoulder/arm pain VAS score of 0.5 – which was significantly better than the mean of 2.1 observed in the ACDF group\n\n\none of the lowest subsequent surgical intervention rates at 3.1 percent for the M6-C disc as compared to other FDA-approved artificial cervical discs\n\n\n\n\nMechanisms of Failure in Bone Ingrowth and Biologic Fixation\n\n\nProposed Taxonomy and Classification of Bone remodeling in Cervical Disc Replacement (CDR)\n\n\nRecommendation for long-term Clinical Management of CDR\n\n\nLessons Learned from artificial joint Hip and Knee Replacements: Implant performance and bone remodeli...