Research In Brief
ReGen: ReGen Biologics' Menaflex collagen meniscus implant supports new tissue ingrowth and improves clinical outcomes in patients with a chronic, though not acute, meniscal injury, according to a study published in the July 3 issue of The Journal of Bone and Joint Surgery. The two-arm study included 157 acute meniscus injury patients, who had had no prior surgery, and 154 chronic injury patients, who had had up to three prior meniscal surgical procedures. Patients were randomized to either receive Menaflex or a partial meniscectomy only. Patients were followed for up to seven years. Menaflex promoted a significantly greater increase in meniscal tissue than partial meniscectomy and the implant supported "meniscus-like matrix production and integration" as it is assimilated and resorbed. Patients in the chronic group treated with the device showed a statistically significant recovery of their pre-injury activity level and underwent significantly fewer reoperations than control patients. However, no difference in activity recovery was detected between Menaflex and control in the acute patients. Menaflex is available in Europe, but the company has not yet been able to convince FDA to clear the product as "substantially equivalent" via 510(k), instead insisting that a PMA application is required (1"The Gray Sheet" Oct. 1, 2007, p. 17)
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