Benvenue Medical, a minimally invasive systems and implants provider, has secured the US Food and Drug Administration (FDA) 510(k) clearance for its enhanced Luna XD MIS expandable interbody device.
Benvenue said that its Luna XD combines anterior lumbar interbody fusion (ALIF) principles with a minimally invasive controlled posterior approach to provide anterior column stability, strength, and fusion in patients with symptomatic degenerative disc disease (DDD).
In addition, it makes use of a small incision, facilitating maximum implant footprint, and providing surgeons with a large graft chamber to facilitate fusion success, maximum height restoration, and optimized sagittal balance, with minimal impaction, neural retraction, or subsidence.
Benvenue Medical CEO Robert K. Weigle said: “With the introduction of Luna XD, we believe that we have an exciting opportunity to advance better patient outcomes through MIS lumbar fusion techniques.
“We are thrilled about the clinician feedback we have received in our early launch of Luna XD, which allows physicians to provide cost-effective, minimally-invasive procedures to patients, with the goal of improving overall quality of life and reducing pain.”
Luna XD is part of the company’s suite of MIS lumbar fusion products that includes the Orbit Articulating Discectomy System.
Orbit is a minimally invasive discectomy system that uses a small, posterior incision to achieve efficient disruption, removal of disc tissue and endplate preparation. It utilises a novel articulating rotary shaver that enables rapid, high-volume removal of diseased tissue.
Weigle added: “In combination with our new Orbit discectomy platform, Luna XD demonstrates our core competency with material science and commitment to developing new products that will change the future of MIS lumbar fusion in both the hospital and increasingly, in the ASC setting.”
According to Benvenue, MIS spine surgery is increasing at a rate of 7.6% per annum and outpatient procedures are expected to grow 35% over the next 10 years.
Benvenue is planning to make the Luna XD initially available as part of a controlled launch at select centres.
Bell Neuroscience co-medical director said Sandeep Kunwar said: “Luna XD is a significant advancement in MIS fusion surgery and offers a more robust and reproducible expandable cage that allows me to put in an ALIF footprint cage, through a TLIF approach with minimal to no nerve retraction. It also allows for endplate to endplate grafting post-expansion.”