The FDA has 510(k)-cleared Benvenue Medical, Inc.'s enhanced Luna® XD MIS expandable interbody device. Luna XD is a multi-expandable interbody fusion device. It took the agency almost six months to clear the device.
Called the Luna 3D GEN2 Interbody Fusion System in the FDA clearance documents, the system consists of the Luna 3D Implant and a set of disposable and re-usable associated accessories. According to the FDA documents, the system, "is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s)."
The Luna XD is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion and is to be used with supplemental fixation.
The implant comes pre-loaded and sterile within a single-use insertion tool and is available in heights ranging from 10mm to 14mm with 2mm increments and a 6° lordotic angle and from 12mm to 16mm with 2mm increments and a 12° lordotic angle.
“A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space. Once the implant is in the desired position, the device is expanded into its ultimate height and forming a bone graft pocket.” Teeth on the outer surfaces of the top and bottom components engage the implant into the adjacent endplates.
The implant is manufactured from polyetheretherketone (VESTAKEEP i4R, conforming to ASTM F2026), nitinol wire (superelastic alloy SE508, conforming to ASTM F2063) and tantalum rod conforming to ASTM F560.
In a June 27, 2019 press release, the company said the Luna XD "utilizes a small incision while providing the largest implant footprint, affording surgeons a large graft chamber to facilitate fusion success, maximum height restoration, and optimized sagittal balance, with minimal impaction, neural retraction, or subsidence. The device is part of Benvenue’s suite of MIS lumbar fusion products that includes the Orbit™ Articulating Discectomy System.
Sandeep Kunwar, M.D., F.A.C.S., Co-Medical Director, Bell Neuroscience, Professor, University of California-San Francisco, stated in the company press release, that the system "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.”
Rick Fessler, M.D., Ph.D., Rush University, added that the company's Orbit System, "combined with the Luna XD makes the procedure more efficient and truly addresses the unmet needs across all discectomy procedures. In 25 years of performing MIS surgery, the Orbit System is the best set of discectomy tools I’ve ever used.”
The company said the system will be available initially as part of a controlled launch at select centers and will be showcased at booth #2516 at The North American Spine Society 34th Annual Meeting in Chicago on September 25-28, 2019.
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