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news.LDR has completed enrollment for the two-level IDE study on its second generation Mobi-C cervical artificial disc.
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LDR began enrolling patients in the first concurrent one and two-level cervical artificial disc study in April of 2006, following nearly two years of clinical experience outside the US.
The product was first introduced outside the US in November 2004 and has now been used to treat over 5,500 patients worldwide, including the 600 patients involved in this FDA study. According to the company, the Mobi-C mobile bearing design reduces the stresses on the bone, thereby eliminating the need for invasive screws or keels.
Christophe Lavigne, president and CEO of LDR, said: “We especially feel that the rapid completion of enrollment in the 2-level arm of our study confirms the need for a multi-level solution such as Mobi-C. We anticipate that enrollment of patients in cervical artificial disc studies will become increasingly difficult as consumers in the US now have cervical artificial disc options available without entering into a clinical trial.”