AUSTIN, Texas, Jan. 27, 2016 (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 “Subsequent surgery rates after cervical total disc replacement using a Mobi-C® Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up” has been published by the Journal of Neurosurgery: Spine (JNS). The paper, lead-authored by Dr. Robert J. Jackson, represents the first peer-reviewed publication of five-year follow-up data on LDR’s Investigational Device Exemption (IDE) trial of the Mobi-C Cervical Disc. On January 22, 2016 the paper was made available in the “Publish Before Print” section of the JNS website. The abstract, as well as the option to purchase the full text, is available online at http://thejns.org/doi/abs/10.3171/2015.8.SPINE15219.
The objective of the paper was to evaluate subsequent surgery rates up to five years in patients treated with cervical Total Disc Replacement (TDR) or anterior cervical discectomy and fusion (ACDF) at one or two contiguous levels between C3 and C7. At five years, the occurrence of subsequent surgical intervention was significantly higher among ACDF patients for one-level (TDR: 4.5% (8/179), ACDF: 17.3% (14/81), p=0.0012) and two-level (TDR: 7.3% (17/234), ACDF: 21.0% (22/105), p=0.0007) treatment.
| Subsequent Surgery Rates at 5 years | TDR | ACDF | |
| One-Level | 4.5% (8/179) | 17.3% (14/81) | p=0.0012 |
| Two-Level | 7.3% (17/234) | 21.0% (22/105) | p=0.0007 |
The study found that patients receiving the Mobi-C Cervical Disc demonstrated significantly fewer index level and adjacent level subsequent surgeries in both the one-level cohort and the two-level cohort.
Christophe Lavigne, President and CEO of LDR, commented, “LDR is very pleased with the five-year follow-up data, and that it has been peer-reviewed, accepted and published in the Journal of Neurosurgery: Spine. We believe that this, and additional papers anticipated to be published this year, will provide further, compelling clinical evidence to support greater adoption of cervical disc replacement with Mobi-C by spine surgeons and insurance companies as a new standard of care for indicated patients.”
The paper concludes, “The results from this clinical trial suggest that TDR may provide a substantial benefit over ACDF in providing a lower risk for subsequent surgical intervention. Furthermore, a lower rate of adjacent level subsequent surgical procedures in TDR patients provides indirect evidence that motion preservation may lead to a lower rate of adjacent level disease than an anterior fusion approach.”
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.
Forward-Looking Statements
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 can be identified by words such as: "anticipate," "intend,” "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. 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, statements regarding the potential effect of published peer-reviewed articles on the adoption of Mobi-C by surgeons and payers, statements regarding publication of future peer-reviewed articles, 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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