Data from the multi-center, randomized trial has been reported by Dr Vikas Patel of the University of Colorado from the first 250 patients enrolled in the trial comparing results of the Superion indirect decompression system to an alternative surgical control device.
The Superion IDE trial enrolled 470 patients at 31 centers in the US. Patients have been randomized 1:1 to either the Superion system or the commercially available X-STOP IPD.
VertiFlex president and CEO Earl Fender said: "This publication is the first to detail the long-term results from our Superion IDE trial.
"I’m pleased that these outcomes are positive and consistent with our previously published international experience. Leg pain scores in this group of patients improved more than 75% from baseline at two years. These results compare favorably with surgical laminectomy, long considered the gold standard for spinal decompression.
"Further, because the Superion procedure does not involve destabilizing muscle resection and bone removal, as is the case with laminectomy, patients are generally able to leave the treatment facility in a few hours, vs. 2-3 days with more invasive surgeries, and return quickly to normal activities.
"This represents a very meaningful change in care for patients suffering from spinal stenosis. Our full data set of 470 patients is now complete and currently under PMA review by the FDA."
Superion is minimally invasive device that is implanted through a cannula about the size of a dime and typically performed under local anesthesia.