Benvenue Medical Inc., a developer of minimally invasive solutions for spine repair, has started enrolling patients in the Luna Interbody System for Fusion Trial (LIFT). 11 patients have already enrolled at two sites: Bonn and Zwickau in Germany.
LIFT is a European post-market, multi-centre, prospective, non-randomized single-arm study aimed at collecting clinical data on the effectiveness of the Luna Interbody Spacer System in spinal fusion procedures for degenerative disc disease, and it received CE Mark approval in 2010. Ultimately the trial will include 100 spine patients at eight sites in Germany, Belgium, Italy and the UK.
Dr Alphonse Lubansu, MD, at Hopital Erasme in Bruxelles, Belgium, the principal investigator for the LIFT study said, “I'm very pleased with the continued progress we're making in the LIFT study. The Luna Interbody Spacer System shows the potential to reduce the invasiveness of spinal fusion procedures. I'm hopeful that the final results will support this initial experience.”
After the completion of enrollment in the LIFT study, the Luna Interbody Spacer System will be commercially available in the EU. Currently this device is not available in the United States. The company intends to submit a 510(k) in the US later this year.
The Luna Interbody Spacer System is designed to address the implant challenges for a true minimally invasive approach to spinal fusion by providing spine surgeons more flexibility in implantation. The System features a small profile designed to expand in-situ within the disc space while allowing the surgeon to customize the contour of the implant to suit individual patient anatomy and surgical preferences. This system incorporates Benvenue Medical's proprietary, flexible PEEK-Optima implant technology. It 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.
Lumbar interbody fusion is the predominant procedure for the treatment of DDD. The global market for interbody spacer implants was over $1.1 billion from more than 350,000 procedures in 2010. Currently, only a small percentage of patients benefit from minimally invasive fusion due to limitations of the existing technologies.
“The Luna Interbody Spacer System represents the realization of the next generation, more minimally invasive approach in spinal fusion procedures for treating DDD,” said Robert Weigle, CEO of Benvenue Medical. “Luna is also an important expansion of our spine product portfolio in Europe beyond our current offering for the treatment of vertebral compression fractures.” Benvenue Medical is entering a $9 billion global spine device market with three breakthrough minimally invasive products to treat vertebral compression fractures (VCFs) and DDD.
Benvenue Medical, Inc. is advancing spine repair through the development of proprietary, minimally invasive surgical and interventional solutions.