AUDUBON, Pa., Nov. 30, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced the results of its seven-year clinical trial follow-up that demonstrate superiority of the SECURE-C® Cervical Artificial Disc over the current standard for the treatment of cervical disc disease, anterior cervical discectomy and fusion (ACDF), based on overall success. SECURE-C® is designed for disc reconstruction and motion preservation at the operated disc level, unlike traditional motion-eliminating fusion surgery.
“The long-term evidence shown in this study confirms the outstanding results I have seen in my own patients treated with SECURE-C®,” said Dr. William Beutler, neurosurgeon at the Pennsylvania Spine Institute. “SECURE-C®’s integrated keel is designed for optimal placement and migration resistance, allowing my patients to better maintain their active lifestyles. SECURE-C® is proven to be a superior treatment option to fusion for patients with cervical disc disease.”
The prospective, randomized Investigational Device Exemption (IDE) trial involved a total of 380 study subjects (240 investigational and 140 control) to compare the safety and effectiveness of SECURE-C® to ACDF using a cervical plate and structural allograft for patients with intractable symptomatic cervical disc disease (SCDD) at a single level in the cervical spine. At seven years post-surgery, SECURE-C®patients reported greater overall satisfaction with surgery and exhibited the following:
- Statistically superior composite overall success results (86.3%) compared to ACDF patients (70.0%);
- Greater improvement in pain and function based on the Neck Disability Index (90.4%) versus ACDF patients (86.0%);
- Lower rate of subsequent surgery (4.2%) at the original treated level compared to ACDF patients (15.3%); and
- Lower rate of adjacent level surgery (4.2%) versus ACDF patients (16.0%).
“The seven-year clinical study findings provide further evidence for statistical superiority of SECURE-C® to ACDF in terms of overall success, bolstering the long term data on cervical arthroplasty,” said Kelly Baker, Ph.D., Senior Vice President of Regulatory and Clinical Affairs. “We are excited to release these findings as Globus continues to bring innovative engineering and superior clinical devices to spine surgeons and their patients.”
The SECURE-C® Cervical Artificial Disc is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The SECURE-C® Cervical Artificial Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation of the SECURE-C® Cervical Artificial Disc.
About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com
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