LDR: More Good News for Mobi-C

LDR Holding Corporation has announced in a March 29, 2016 news release that, “Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of two-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial” has been published by the Journal of Neurosurgery: Spine. “Mobi-C provided statistically significant greater improvement in general and disease specific outcome measures compared to anterior cervical discectomy and fusion (ACDF). Additionally, there was a lower incidence of index level and adjacent level reoperation with cervical total disc replacement (cTDR).”

The paper’s authors were: Kris Radcliff, M.D., associate professor in Orthopedic Surgery and Neurosurgery at Thomas Jefferson University, Domagoj Coric, M.D., chief of Neurosurgery at Carolinas Medical Center, and Todd Albert, M.D., surgeon-in-chief and medical director and Korein-Wilson Professor of Orthopaedic Surgery at Hospital for Special Surgery.

Christophe Lavigne, President and CEO of LDR, commented, “…For the first time in the history of spinal medicine, clinical evidence of two-level cervical disc replacement outcomes, out to five years, has been peer-reviewed and published, and the findings are very encouraging. Two-level cervical total disc replacement has been proven as a safe and effective treatment with statistical superiority in overall outcome as compared to the previous gold standard of treatment, ACDF. Mobi-C is the only cervical disc replacement device available in the U.S. that can be used on-label to treat two-level cervical pathology, and is also associated with the additional benefits of reduced adjacent segment degeneration and significantly lower reoperation rate. Even after 60 months, patients treated with Mobi-C report high levels of satisfaction, pain relief, and willingness to recommend the surgery to a friend…”

Asked about surgeon education, Joe Ross, executive vice president of Global Marketing, LDR spine, told OTW, “Surgeon training and education is and will continue to be one of the top priorities for LDR going forward. As of the end of 2015, over 2, 200 surgeons have been trained on Mobi-C since its U.S. launch. LDR offers medical professionals a variety of educational opportunities, including didactic, peer-to-peer, and cadaver based training, as well as surgeon visitation programs. Through these trainings, surgeons have the opportunity to interact with our experienced faculty and leave with confidence in offering Mobi-C technology to their patients.

“In 2015, Mobi-C was our highest revenue-generating product in the U.S., with a growth rate of nearly 80%. We believe that market dynamics are evolving well to position cervical disc replacement as the most promising segment in the spine industry, thus increasing the demand for Mobi-C technology.”

“Additionally, the continued publication of long-term clinical evidence, such as the latest five-year clinical results by the Journal of Neurosurgery: Spine, combined with previously published cost-effectiveness data, the NASS [North American Spine Society] coverage recommendation, and various other long-term positive clinical results in support of one and two-level disc replacement will drive Mobi-C’s penetration of the estimated $1.2 billion U.S. cervical fusion market.”

The company notes that, “All of the authors are independent without any institutional or financial bias. They had no prior involvement in the Mobi-C cTDR study or any other consulting or financial relationship with LDR. The authors were given complete and unrestricted access to the Mobi-C cTDR study data, and retained full authority for manuscript content, including the discussion and conclusions.”