Benvenue Medical has initiated enrolling patients for luna interbody system for fusion trial (LIFT) study.
The European post-market, multi-center, non-randomized, prospective and single-arm study is designed to study safety and effectiveness of the Luna interbody spacer system.
The trial will include 100 spine patients at eight sites in Germany, Belgium, Italy and UK.
The company said 11 patients have already been recruited at two sites (Bonn and Zwickau) in Germany.
The Luna interbody spacer system utilizes the company’s proprietary, flexible PEEK-Optima implant technology and is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L1-S1.
The system features a small profile and is designed to address the implant challenges for a true minimally invasive approach to spinal fusion by providing spine surgeons more flexibility in implantation.
LIFT study principal investigator Alphonse Lubansu said the Luna interbody spacer system shows the potential to reduce the invasiveness of spinal fusion procedures.
The system has received CE mark approval in 2010 and is not available for sale in the US.
The company intends to submit a 510(k) application to the US Food and Drug Administration (FDA) later in 2012.