Globus Medical’s SECURE®C Cervical Artificial Disc Receives Expanded Insurance Coverage
Approved by the
At seven-year post-operative follow-up, patients treated with SECURE-C® exhibited the following results compared to patients treated with ACDF:
- Statistically superior composite protocol-specified overall success results (86.3% vs. 70.0%)
- Statistically superior composite
FDA-defined overall success results (79.2% vs. 63.6%)
- Greater percentage of patients with at least 25% improvement in Neck Disability Index, a measure of pain and function (90.4% vs. 86.0%)
- Lower rate of subsequent surgery at the original treated level (4.2% vs. 15.3%)
- Lower rate of adjacent level surgery (4.2% vs. 16.0%)
“The long term clinical results validate that SECURE-C® creates a significant improvement in patients’ lives over the long term, an important factor in expanding payer coverage,” said Globus Medical’s President,
For more information about SECURE-C®, please visit GlobusMedical.com/SECURE-C.
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.
Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the
Source: Globus Medical