Vikas Patel, MD, from Denver-based University of Colorado, and colleagues, reported outcomes from the first 250 patients enrolled in a prospective, multi-center, randomized U.S. Food and Drug Administration Investigational Device Exemption trial. The trial involved the enrollment of 470 patients in total.
The study found that leg pain scores in the Superion Indirect Decompression System group of patients improved by more than 75 percent from baseline at two years. Also, Superion patients were generally able to leave the treatment facility in a few hours.
The full data set of 470 patients is complete and under review by the FDA.
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