Orthofix Medical touts data from artificial disc study

Orthofix Medical’s M6-C artificial cervical disc (Image from Orthofix) A study of patients implanted with Orthofix Medical’s (NSDQ:OFIX) M6-C artificial cervical disc showed a significant improvement in neck and arm pain, function and quality of life scores, the company said today. Patients in the investigational device exemption (IDE) study also used less pain and opioid medication when compared with anterior cervical discectomy and fusion (ACDF) patients, and 92% reported they were satisfied with the surgery, the Lewisville, Texas-based business said in a prepared statement. At 24 months, patients in the ACDF group who were still using pain medications had a seven times higher rate of opioid use than those in the M6-C disc group, the study showed. In the M6-C group, 92% reported that were satisfied with the surgery. “The results from the M6-C artificial cervical disc IDE clinical study continue to validate the positive outcomes of cervical disc arthroplasty versus discectomy with fusion,” said Dr. Jack Zigler, an orthopedic spine surgeon at Texas Back Institute and an investigator in the study. “A significant reduction in pain, the maintenance or improvement of neurological function, and the preservation of natural disc motion after 24 months were all meaningful clinical benefits the M6-C disc patients experienced when compared to the fusion control.” Zigler presented the study results during the International Society for the Advancement of Spine Sur...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Clinical Trials Featured Food & Drug Administration (FDA) Implants News Well Orthopedics internationalsocietyfortheadvancementofspinesurgery (ISASS) Orthofix Source Type: news