Axis Spine Technologies, Ltd. was granted FDA 510(k) clearance on May 20, 2020 for its first device, a modular interbody fusion device for anterior lumbar interbody fusion (ALIF), the Axis-ALIF. The device was cleared just over three months after submission for single and contiguous 2-level use.
The company plans to have the device available for surgery by August or September of this year. Axis Spine, based in St. Albans, UK near London, decided to forego CE marking preferring to first enter the U.S. market. There, the company hopes to generate clinical data to support future clearances.
“We are really pleased and grateful to have received such timely clearance from the FDA given the current situation. We now have the opportunity to bring this technology and its benefits to American patients ahead of plan. The next few months will be a very exciting time for the company,” said Jon Arcos, company Founder and CEO.
Prior to founding Axis Spine Technologies, Jon Arcos had nearly seven years of experience in international and UK commercial development with NuVasive, Inc. In that role Arcos was responsible for establishing a direct sales operation and presence in the region.
The Axis-ALIF is a novel interbody fusion device that uses modular components to create a custom implant with over 400 combinations using fewer than 50 parts. Surgeons will have a choice of 3 titanium endplate footprints with both sagittal and coronal angle options.
Coronal angle correction is typically not available from interbody fusion devices, so this marks a unique advantage to the Axis-ALIF. A range of titanium core inserts that offer further customization options for intervertebral height and lordotic angle of the assembled implant are available, too.
The device also incorporates zero-profile, integrated fixation to prevent device expulsion. Supplemental fixation, such as an anterior plate or posterior rod and screws are required for on-label use of the device. In addition to a wide range of sizes and angles, the insertable cores and endplates feature a large graft window to the neighboring vertebral bodies, and a single opening on the anterior surface allows for in situ graft application. Absence of side windows, and an anterior cover is intended to limit graft leakage.
Step 1: Endplates are inserted into the intervertebral space; Step 2: The modular core is inserted; Step 3: Anchor screws, graft and cap are added to complete the implant / Source: Axis Spine Technologies, Ltd.
The insertion procedure has a few more steps than traditional single-piece interbody devices, but allows for substantially more customization to meet the needs of the patient. First, the endplates are inserted with little distraction needed, reducing trauma to the vertebral bodies and surrounding tissues. Once the endplates are placed, the appropriate modular core is inserted and screws are used to anchor the components. Bone graft is packed through the anterior window, and a cover is affixed over the graft window to prevent graft leakage, and to further prevent the locking screws from backing out.
Future iterations of the device may include anatomic endplates that will allow the surgeon to choose different dome heights for the superior and inferior endplates. Additionally, cores made of PEEK, and endplates with porous titanium plasma spray are expected in future updates. Arcos told OTW that the Axis-ALIF brings together the stability of single piece interbody device designs with the ability to gently adjust the spine like an expandable interbody device. The Axis-ALIF also gives surgeons the freedom of independently customizing the height and lordosis of the assembled device, something usually only available in specific ratios with other devices.
When asked why the company decided to approach a modular design, rather than a completely customized, 3D-printed implant, Arcos told OTW that it wasn’t what surgeons needed. When he asked surgeons during the design phase of the Axis-ALIF he found that surgeons often need a slightly different size once they actually have the patient open on the table. If a patient-specific, customized implant were offered, surgeons would want to have the size they think they want based on preoperative MRI or CT, as well as one slightly larger, and one slightly smaller, in case the anatomy is slightly different than expected.
The cost of production of customized implants would be prohibitive for realistic use. The modular system mimics what has worked well for knee and hip replacement and revision devices, which allow the surgeon to mix and match components to get the best overall fit for the patient.
Some surgeons are already anticipating the release of the Axis-ALIF with excitement. Matthew Ammerman, M.D., is an assistant clinical professor of neurosurgery at George Washington University School of Medicine, and a practicing surgeon at Washington Neurosurgical Associates at Sibley Memorial Hospital and George Washington University Medical Center specializing in minimally invasive spine surgery.
Ammerman listed many of the benefits of the new device, “The new Axis ALIF will bring demonstrable and unique benefits to patients, surgeons and facilities alike. It’s modular design will improve inventory management for hospitals and vendors while permitting surgeons to construct countless custom implant configurations best suited to each patient’s individual anatomy. It’s unique atraumatic insertion technique will also promote surgical safety by minimizing the force needed to implant the device, reducing the risk of vertebral fracture. In short, Axis has built a “better mousetrap” for anterior spinal column reconstruction.”
Future directions for the company include development of additional lumbar fusion devices for other approaches such as OLIF, LLIF, and A-OLIF implants. Additionally, plans are in the works for a purpose-built retractor system to further support the insertion and assembly procedure.
