Spinal Elements announced on Mar. 20 that it has received 510(k) clearance from the Food and Drug Administration for its Ventana A Anterior Lumbar Interbody Fusion (ALIF) System, with the first surgeries using the device already performed in Texas.
The clearance marks an expansion of Spinal Elements’ range of 3D printed titanium interbodies for lumbar and cervical fusion procedures. The company is introducing Ventana A through a limited market launch, aiming to advance spinal fusion techniques and improve outcomes for both surgeons and patients.
According to Spinal Elements, the Ventana A system features a unique hinged architecture designed to maximize bone graft volume and containment during implantation. The specialized 3D printing process is intended to help surgeons restore segmental alignment and stability while minimizing titanium density. The device also aims to provide optimal load sharing to reduce potential subsidence risk and improve visualization during surgery.
“ALIF is a powerful procedure and a workhorse for many spine surgeons, which is why we set out to develop a best-in-class system that maximizes its clinical benefits,” said Ron Lloyd, Chief Executive Officer. “Building on the proven Ventana platform, this contemporary system increases Spinal Elements’ portfolio offering and procedural reach to a greater number of surgeon and distribution partners. Combined with intuitive instrumentation and efficient packaging, Ventana A is designed to enhance clinical performance and operating room efficiency, demonstrating our commitment to continued innovation – working with surgeon partners to develop systems that are meaningfully differentiated and deliver improved outcomes.”
The first case using Ventana A was performed by Dr. A.J. Rush III at Texas Spine Consultants in Addison, Texas. “The Ventana A system delivers a clinical advantage to everyday challenges for spine surgeons,” said Dr. Rush. “The large graft window allows for maximal graft delivery as well as improved visualisation for fusion assessment and distributes load across the entire surface to reduce subsidence risk. Having used the instrumentation in both lab and clinical settings, I can attest to Ventana A’s ability to offer a best-in-class ALIF solution.”
Dr. Rory Mayer, a neurosurgeon at Texas Spine & Scoliosis in Austin, also commented: “Ventana A is truly a bone graft delivery vessel. It has everything needed to maximise fusion potential for my patients: porous 3D printed titanium interbody, a large opening to facilitate bone graft placement, and a hinged lid to contain the bone graft and prevent graft from migrating from the interbody device during insertion into the disc space.”
With FDA clearance secured and initial cases completed in Texas, Spinal Elements plans further introduction of the device through its limited market launch.
