AUSTIN, Texas, Oct. 29, 2014 (GLOBE NEWSWIRE) -- LDR Holding Corporation (Nasdaq:LDRH), a global medical device company focused on designing and commercializing novel and exclusive surgical technologies for the treatment of patients suffering from spine disorders, announced that JAMA Surgery, a peer-reviewed publication, has published a cost-effectiveness study of the two-level Mobi-C® Cervical Disc in comparison to two-level Anterior Cervical Discectomy & Fusion (ACDF).
The paper, Ament JD, et al: Cost-Effectiveness of Cervical Total Disc Replacement vs Fusion for the Treatment of 2-Level Symptomatic Degenerative Disc Disease, JAMA Surg. was published online on October 8, 2014, with print publication to follow. The study, authored by Jared Ament, M.D., MPH with the UC Davis Health System Neurosurgery Department, utilized the clinical data from the two-level Mobi-C vs. ACDF randomized controlled trial in order to assign health states for the patient population. Costs were derived from institutional billing data at the Investigational Device Exemption (IDE) trial sites. The research team used decision analytical modeling to generate Quality-Adjusted Life-Years (QALY) and Incremental Cost-Effectiveness Ratios (ICER) for both treatment groups. QALY is a measure of disease burden and assesses the value for the money associated with a medical intervention. QALY is based on the number of years of life that a given intervention would add to one's life. ICER is the ratio of the change in costs to incremental benefits of a therapeutic intervention or treatment. An intervention with a lower cost to QALY saved ratio (ICER) would be preferred over an intervention with a higher ratio.
The objective of this paper was to determine the cost-effectiveness of cervical total disc replacement (CTDR) compared to ACDF for two-level cervical disc disease. The study found CTDR with Mobi-C appears to be a highly cost-effective surgical modality compared with ACDF for the treatment of two-level cervical disc disease.
Key findings of the study include:
- The ICER of CTDR over ACDF is $24,594 per QALY, lower than the commonly used US ICER threshold of $50,000 per QALY, suggesting that CTDR is a "highly cost-effective option."
- CTDR is not only a cost-effective option for 2-level cervical disc disease, but from a societal perspective, it imparts a greater quality of life at less cost over a 4-year period.
"The statistical superiority of Mobi-C compared to ACDF for two-level indications has been demonstrated through the IDE for the overall composite primary effectiveness endpoint at 24 months, and the PMA for two-level indications was approved by the FDA in 2013," said Christophe Lavigne, President and CEO of LDR. "In today's US healthcare environment we knew it would be important to determine the cost-effectiveness of Mobi-C as compared to ACDF, the historical standard of care. We are excited to have this very important economic analysis of Mobi-C published, especially in such a prestigious journal as JAMA Surgery. The principal finding of this study, that Mobi-C appears to offer improved cost-effectiveness for two-level replacement (based on the 24 month outcomes), is an important factor for consideration by healthcare providers.
Mobi-C IDE Study
The Mobi-C Cervical Disc, the only cervical disc FDA-approved for one and two-level use was compared to 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 24 months of follow-up for one-level use and statistically superior in terms of the overall study success at 24 months of follow-up for two-level use.
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.
About LDR Holding
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 U.S. Food and Drug Administration (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 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, including the importance of the data regarding Mobi-C's cost-effectiveness as compared to ACDF, and the potential impact on Mobi-C sales. 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 March 4, 2014, and in LDR's other filings with the SEC. LDR disclaims any responsibility to update any forward-looking statements.
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