TranS1's two-level spinal fusion product:
This article was originally published in Clinica
Executive Summary
TranS1 has received US FDA 510(k) clearance for its AxiaLIF 2L two-level percutaneous lumbar fusion system. The Wilmington, North Carolina company's AxiaLIF (axial lumbar interbody fusion) single-level approach was cleared by the FDA in 2004. The older product allows surgeons to access the L5-S1 vertebrae via a one-inch (2.54cm) opening, while AxiaLIF 2L is designed to treat degenerative disc disease at both the L5-S1 and L4-L5 lumbar discs through a single 1.5 inch (3.81cm) incision. TranS1 said there were similar advantages with both minimally-invasive procedures - early release from hospital, rapid return to normal activities and long-term reduction of leg and back pain. AxiaLIF 2L is already available in Europe.