LDR became the first company to receive an approvable letter from FDA for its cervical disc. The milestone followed a 600-patient concurrent IDE clinical trial for both one- and two-level cervical disc replacement. The company hopes that the Mobi-C device will be commercially available in the United States in 2013.
To learn about the device, MD+DI editor-at-large Brian Buntz spoke with the company's vice president of U.S. marketing, Joe Ross. In the interview, Ross notes that there are an estimated 250,000–275,000 anterior surgical procedures performed each year in the United States. Cervical disc replacement could potentially be used in up to 40% of these patients.