Spinal Elements has been granted FDA 510(k) clearance for its 3D printed Ventana A Anterior Lumbar Interbody Fusion (ALIF) System.
Introduced through a limited market launch, Ventana A has been designed to facilitate lumbar and cervical fusion. Its hinged architecture is said to be unique and works to maximise bone graft volume and containment throughout implantation.
A specialised 3D printing process is deployed to engineer Ventana A, with the resulting product 'restoring segmental alignment and stability, minimising titanium density, providing optimal load sharing to mitigate potential subsidence risk, and improving visualisation.'
"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 maximises its clinical benefits," said Ron Lloyd, Chief Executive Officer of Spinal Elements. "Building on the proven Ventana platform, this contemporary system increases Spinal Elements' portfolio offering and procedural reach to a greater number of surgeons 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".
Since FDA clearance was granted, implantations of Ventana A devices have commenced. The first case was performed by Dr. A.J. Rush III at Texas Spine Consultants in Addison, TX.
Dr. Rush said: "The Ventana A system delivers a clinical advantage to everyday challenges for spine surgeons. 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 practising at Texas Spine & Scoliosis in Austin, TX, added: "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."
Spinal Elements' Ventana A ALIF system is just the latest in a range of 3D printed implantable devices to hit the headlines this year. Last week, Stryker unveiled its latest 3D printed orthopaedic device with Triathlon Gold, while Materialise added PEEK to its cranio-maxillofacial implant options last month, and restor3d announced its 3D printing-enabled Ossera AFX Ankle Fusion Cage System is now commercially available just a week earlier.
XJet's NanoParticle Jetting technology has also been leveraged in recent times by Nivalon to additively manufacture an AI-designed patient-specific spinal implant product which is set for first in-human procedures in later this year.
