AUSTIN, Texas, Nov. 17, 2015 (GLOBE NEWSWIRE) — LDR Holding Corporation (Nasdaq:LDRH), a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, today announced that the North American Spine Society (NASS) has revised its formal coverage recommendation for Cervical Artificial Disc Replacement (CADR). The evidence-based coverage policy recommendation, recently released by NASS, now includes support for both one and two-level CADR when clinically indicated (radiculopathy or myelopathy from disc degeneration following appropriate non-operative care). The Coverage Committee states that the “rationale for coverage of CADR is based on the indications and results of many randomized controlled trials (RCTs) that have compared the procedure to what most would consider the gold standard surgical treatment, anterior cervical discectomy and fusion (ACDF).”
Christophe Lavigne, President and CEO of LDR, commented on the NASS coverage recommendation: “NASS is a global multidisciplinary medical society that utilizes education, research and advocacy to foster the highest quality, ethical, value- and evidence-based spine care for patients, so its recommendation for both one and two-level cervical disc replacement as a treatment option for those patients who satisfy the clinical indications is a major milestone in the treatment of cervical disc degeneration. The revised NASS policy recommendation further validates the emergence of CADR as an alternative to ACDF in appropriate patients and should help to further expand coverage for the Mobi-C® Cervical Disc for both one and two-level procedures in the United States.”
Mobi-C Cervical Disc
Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement for both one and two-level indications. All other cervical disc prostheses are FDA approved for one-level use only. In addition to the unique mobile-bearing feature, Mobi-C offers a simplified surgical technique.
The Mobi-C Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI, or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels. The Mobi-C Cervical Disc Prosthesis is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the Mobi-C Cervical Disc Prosthesis.
About LDR Holding Corporation
LDR Holding Corporation is a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders. LDR’s primary products are based on its exclusive Mobi® non-fusion and VerteBRIDGE® fusion technology platforms and are designed for applications in the cervical and lumbar spine. These technologies are designed to enable products that are less invasive, provide greater intra-operative flexibility, offer simplified surgical techniques and promote improved clinical outcomes for patients as compared to existing alternatives. In August 2013, LDR received approval from the FDA for the Mobi-C cervical disc replacement device, the first and only cervical disc replacement device to receive FDA approval to treat both one-level and two-level cervical disc disease. For more information regarding LDR Holding and the Mobi-C Cervical Disc, visit www.ldr.com or www.cervicaldisc.com.
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include the intent, belief or current expectations of LDR and members of its management team with respect to LDR’s future business operations as well as the assumptions upon which such statements are based. Factors that could cause actual results to differ materially from those contemplated within this press release can also be found in LDR’s Risk Factors disclosure in its Annual Report on Form 10-K, filed on February 20, 2015, and in LDR’s other filings with the SEC. LDR disclaims any responsibility to update any forward-looking statements.
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