Audubon, Pa.-based Globus said the decision means the device is covered by the major third-party payers in all 50 states. Anthem has more than 73 million lives under its coverage umbrella, according to Globus. The Secure-C device won pre-market approval from the FDA in 2012 and is is designed to restore normal movement to the neck in patients with disc problems that produce neck and arm pain. It consists of 2 cobalt-chrome endplates and a central polyethylene core that mimics the function of a healthy spinal disc.
Globus said that its seven-year follow-up data show that patients implanted with the device showed statistically superior overall success results (86.3% vs. 70.0% of patients treated via anterior cervical discectomy & fusion); statistically superior composite FDA-defined overall success (79.2% vs. 63.6% for the ACDF comparator); a higher rate of patients showing at least 25% improvement in Neck Disability Index, a measure of pain and function (90.4% vs. 86.0%); a lower rate of subsequent surgery at the original treatment site (4.2% vs. 15.3%); and a lower rate of adjacent-level surgery (4.2% vs. 16.0%).
“The long-term clinical results validate that Secure-C creates a significant improvement in patients’ lives over the long term, an important factor in expanding payer coverage,” president Anthony Williams said in prepared remarks. “With the addition of Anthem, Secure-C is now covered by all major third-party payers in every state and strengthens our position for growth in the cervical artificial disc market.”