“The Luna Interbody Spacer System shows the potential to reduce the invasiveness of spinal fusion procedures.”
Californian minimally invasive spinal company Benvenue Medical, Inc., has announced that it has actively started enrolling patients in the Luna Interbody System for Fusion Trial (LIFT). The system is already CE marked and will be rolled out following enrollment of the trial’s 100 patients, eleven of which have already been recruited.
Lumbar interbody fusion is the predominant procedure for the treatment of degenerative disc disease (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 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’s small profile is designed to expand in-situ within the disc space while allowing the surgeon to customise the contour of the implant to suit individual patient anatomy and surgical preferences.
The system incorporates Benvenue Medical’s proprietary, flexible PEEK-Optima® implant technology. It is indicated for spinal fusion procedures in skeletally mature patients with symptomatic DDD at one or two contiguous levels from L1-S1.
The LIFT study
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.
Eleven patients have already enrolled at two sites (Bonn and Zwickau) in Germany.
Dr. Alphonse Lubansu, M.D., 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.”
“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.
After the completion of enrollment in the LIFT study, the Luna Interbody Spacer System will be made 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.
Source: Benvenue Medical Inc., PR Newswire