AUSTIN, Texas, Oct. 13, 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 U.S. Food and Drug Administration (FDA) has approved an update to the Mobi-C® Cervical Disc labeling to include five-year clinical results. The updated data remains consistent with the previous findings at 24 months, namely, that at 60 months of follow-up, Mobi-C is statistically non-inferior in terms of overall study success for one-level use and statistically superior in terms of overall study success for two-level use.
Dr. Hyun Bae, a board-certified orthopedic surgeon at The Spine Institute Center for Spinal Restoration in Santa Monica, California and Professor of Surgery and Director of Spine Education at the Cedars-Sinai Spine Center, noted, “As both a researcher and a spine surgeon, I appreciate the value and importance of this landmark milestone. The 60-month follow-up data from the study demonstrated consistent and compelling results over time and supports continued confidence in the Mobi-C Cervical Disc for the treatment of indicated patients.”
In the two-level arm of the Investigational Device Exemption (IDE) trial, Mobi-C demonstrated superiority in overall trial success compared to the control anterior cervical discectomy and fusion (ACDF) treatment, which has been the traditional option for treating cervical degenerative disc disease. Specific findings comparing Mobi-C to ACDF in the two-level study at the 60-month endpoint include:
- Mobi-C implanted at two contiguous levels demonstrated statistical superiority in overall trial success compared to ACDF. The difference between Mobi-C’s overall success rate of 62.8% and ACDF’s rate of 34.1% represented statistical superiority (p< 0.0001) according to the IDE study overall success criteria.
- The rate of subsequent surgery at the index level was lower for Mobi-C at 3.8% compared to 16.2% for ACDF.
- The percentage of subjects who showed no negative radiographic changes from baseline in adjacent segments was:
- 77.5% of Mobi-C patients compared to 44.9% of ACDF patients at the inferior adjacent level (p<0.0001); and
- 67.4% of Mobi-C patients compared to 29.2% of ACDF patients at the superior adjacent level (p<0.0001).
- Mean return to work time was 45.9 days for Mobi-C compared to 66.8 days for ACDF.
- Mobi-C showed a 82.0% improvement in Neck Disability Index (NDI) based on success criteria compared to 56.6% for ACDF, where NDI success is defined as greater than or equal to 15-point improvement in subjects with baseline NDI greater than or equal to 30 points, or greater than or equal to 50% improvement in subjects with baseline NDI less than 30 points.
- Mobi-C is a safe and effective surgical option at two contiguous levels in the cervical spine from C3-C7 for indicated patients.
Dr. Scott Blumenthal, a board-certified orthopedic spine surgeon and Co-Director at the Center for Disc Replacement at Texas Back Institute in Plano, Texas, shared, “As an advocate of cervical disc arthroplasty, and having participated in LDR’s concurrent one and two-level prospective IDE clinical trial, I am pleased with the excellent level of follow-up, and proven clinical results. This data provides compelling evidence that cervical disc replacement with Mobi-C should be the treatment of choice for indicated patients and may represent the new gold standard.”
“The FDA approval of LDR’s Mobi-C labeling updated with five-year safety and efficacy data from the Mobi-C clinical trial is another important milestone enabling LDR to train and educate surgeons and patients about this innovative product and its clinical benefits,” said LDR President and CEO Christophe Lavigne. “The exceptional 60-month study follow-up rates of 83.6% and 89.2%, for the one and two-level cohorts, respectively, speak to the quality of the study design and committed efforts to collect the data. In addition to bolstering the continued support from surgeons, the statistical superiority in overall success of Mobi-C to ACDF at two levels will serve as additional evidence to further the confidence of insurance payers in cervical disc replacement. This is a win for all patients indicated for the treatment. LDR is the first and only medical device company to offer a two-level cervical disc with statistical superiority to ACDF, confirmed by 5-year clinical data. This marks a new era in the spine device industry that may benefit thousands of patients. I believe that the data further supports the conclusion that Mobi-C may represent a new standard of treatment for indicated patients.”
Mobi-C IDE Study
The Mobi-C Cervical Disc, the only FDA approved disc for one and two-level use, was compared to one and two-level ACDF utilizing allograft bone and anterior cervical plating with screws in an IDE trial. Results found Mobi-C to be statistically non-inferior in terms of the overall study success at 60 months of follow-up for one-level use and statistically superior in terms of the overall study success at 60 months of follow-up for two-level use. These results are consistent with the 24 month follow-up results previously reviewed and approved by the FDA.
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 PMA approval from 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 or prospects, market acceptance of its products, commercial success of its products, future updates to the Mobi-C IDE study, competing medical devices, 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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Source:LDR Holding Corporation