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The Way Back: A Report on Spine Technologies

MIS approaches, improved implant coatings, and ASC-approved instruments are shaping treatment solutions for the world’s diseased and damaged spines.

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By: Michael Barbella

Managing Editor

Joshua Sonnier still can’t figure out how he hurt himself.

It’s not for lack of trying—the former bodybuilder-turned-fitness trainer has replayed the moment countless times in his mind, but the injury remains as much a mystery at present as the day it occurred.

“We was playing a little basketball game, some of my athletes, and we was having a little dunk contest,” Sonnier recounted in an online video. “On the last dunk, something happened. I was jumping and twisting, so when I planted and I rotated and accelerated up, I felt it. I felt something crack, it was bad. And then when I hit the ground, I felt it again. Immediately it went to stiffening down the left leg. It wasn’t good at all.”

Not by any means.

Somehow, in performing all those mid-air contortions and hard landings, Sonnier damaged one of his lumbar discs. Commonly referred to as herniated, bulging, or protruding (discs), these injuries are among the most common causes of lower back pain, as well as leg pain or sciatica, afflicting between 60% and 80% of the global population, according to OrthoInfo data.

Lumbar disc injuries (or herniations) typically occur in the lower lumbar spine, at the L4-L5 (fourth and fifth lumbar vertebrae) or L5-S1 (fifth lumbar-first sacral vertebra) disc space. And while they often are a byproduct of the natural aging process, herniated discs also can result from sudden trauma—like a fall, improper lifting, or abrupt jerking movements.

Or, perhaps jumping and twisting to slam dunk a basketball.

“He [Sonnier] had a bad lumbar disc and it was keeping him from doing the things that he really liked to do,” said Jayme Trahan, M.D., a neurological spine surgeon with Lafayette Bone & Joint Clinic (Lafayette, La.). “…he was just really looking to get back to that lifestyle that he enjoys.”

That lifestyle included basketball games (of course), workouts and training sessions at the gym he co-owns (Fame Fit Factory), and activities with his young daughter.

“How long would it take before I got back to work? That was my biggest concern,” Sonnier stated in a distinct southern Louisiana drawl. “The way my business runs is if I’m not at work, I don’t get paid. When do I get back to me?”

Sooner than he anticipated, actually, thanks to a non-traditional surgical technique that accesses the lower spine through the front of the body. Anterior lumbar interbody fusions (ALIF) provide neurosurgeons a direct path to the spine through an abdominal incision, thereby sparing back muscle and tissue. The approach can be performed as an open surgery or a less invasive procedure, depending upon the patient’s condition and medical history.

While entering through the abdomen requires some shifting of blood vessels and organs, it nevertheless provides several benefits over the more conventional posterior (back) approach—namely, faster recovery, less muscle injury, improved lordosis (swayback), and better support through a larger cage size.

In ALIF procedures, a plate and screws, or an integrated plate-spacer and screws may be used to hold the affected vertebrae in place while fusion occurs. Sometimes, the anterior approach is followed with posterior stabilization, where rods and screws are affixed through the back of the body to further secure the vertebrae.

“With how active he is, I think he [Sonnier] was a great candidate for this approach where we can come in from the front—anterior lumber interbody fusion,” Dr. Trahan remarked. “You can stick a very sizable graft, restore height, optimize fusion capabilities, and really kind of restore a lot of that natural alignment and curvature within the spine that you can’t get with a posterior approach.”

Dr. Trahan reinstated the natural alignment of Sonnier’s unhealthy disc with Camber Spine’s ENZA-A Titanium ALIF interbody fusion implant. Cleared by the U.S. Food and Drug Administration (FDA) in June 2018, ENZA’s 3D-printed body has a roughened surface that fosters bone growth onto the device’s cranial and caudal areas. The pores on its upper and lower faces average 500 microns in diameter—the optimal environment for bone growth and full incorporation within the vertebral body. The ENZA-A has multiple openings to accommodate large volumes of autogenous bone graft, and its two anchor plates remain housed within the 3D-printed body until they are deployed into the vertebrae for fixation.

Inserted, deployed, and locked with a single pass, the ENZA-A is available in three footprints and three lordotic profiles to allow for different patient anatomies.

“The 3D printed roughened surface of the ENZA spacer allows direct bony ingrowth onto the actual spacer,” Dr. Trahan said. “…with the [Camber] inserter, it’s very streamlined. Everything can work through a very small corridor whereas before you would need larger surface areas. That makes the incision smaller, that’s less tissue trauma, and that’s less intraoperative bleeding.”

And less healing time. Sonnier missed only a week of work, and returned to his training sessions with the same pre-surgical intensity level (most likely better, since he was now pain-free).

“No rehab, I was back to work in a week, and I’m talking back to work. Back to my old self,” Sonnier recalled, smiling. “So now, I can bathe my little girl. The other day, I got up early and took her to the zoo. She was so excited, ‘Daddy, Daddy, you can hold me now?’ The fact that I can carry her around the zoo with her on my back…that’s what made it all worthwhile.”

Worthiness, of course, is relative, and now more feasible than ever to patients living with chronic low back pain and other spine-related conditions. Sonnier’s treatment path is just one of numerous routes available to patients traversing the spinal sector’s increasingly crowded solutions superhighway.

Advancements in materials, manufacturing, software, and technology (artificial intelligence and otherwise) in recent decades have spawned remedies to suit almost all types of patients, surgeons, and conditions. Diseased/damaged spines are now accessible through the front (anterior), back (posterior), or side (lateral) of the body, procedures can be minimally invasive (or not), and surgeons can leverage robotic assistance (or not) in hospitals (or not).

“There’s a big paradigm shift to ambulatory surgery centers [ASC]. More spine indications have been approved for ASC cases to reduce procedural and lifecycle cost while producing successful outcomes and patient satisfaction,” said James B. Schultz, vice president of customer solutions for Thousand Oaks, Calif.-based ECA Medical, a designer and manufacturer of single-procedure torque-limiting instruments and sterile-packed, surgery ready procedural kits to the medical implant industry. “Many spine surgeons practicing in ASCs are making the case to CMS that complex spine procedures can be performed safely in the outpatient setting. They argue case volume is the top growth opportunity coupled with capturing additional traditionally complex inpatient procedures.”

Robot-friendly surgeons can pre-operatively plan their procedures, better navigate the body’s anatomical support structure, and improve implant placement precision with the help of Medtronic plc’s Mazor X Stealth Edition, Zimmer Biomet’s ROSA system, DePuy Synthes’ VELYS Active Robotic-Assisted System (VELYS SPINE), or Stryker’s Mako Spine, due to debut later this year.

VELYS is the newest of the bunch, having made its debut in early August. DePuy Synthes developed the system with eCential Robotics, which gained FDA clearance two years ago for its own open, unified, modular, and scalable robotics platform. The French firm augmented that offering this past July with FDA-authorized spine capabilities for planning and fusion procedures in the cervical, thoracolumbar, and sacroiliac spine.

VELYS SPINE is designed as a dual-use system offering standalone navigation and a customizable experience with pathology-specific workflows supported by capabilities like the VELYS Adaptive Tracking Technology and VELYS Trajectory Assistance. Its active robotics platform gives surgeons flexibility in their planning and approach, enabling procedural guidance tailored to surgeon preference.

VELYS SPINE’s active robotics feature has figured prominently in the system’s marketing campaign as DePuy Synthes attempts to distinguish its spinal robotic platform from the more established and clinically proven Mazor and ROSA systems. DePuy Synthes is touting active robotics as a revolutionary technology, contending its distinctive features and capabilities could help establish a “new standard” in spine surgical care when VELYS SPINE hits the market in the first half of 2025.

“Surgeons entering practice are looking for enhancements to accuracy, efficiency, and usability through tech-enabled hardware while ensuring that platform components are connected and talking to one another,” stated Keith Evans, vice president/general manager of Enabling Technologies at Stryker’s Spine Division. “We are seeing competitors focus on developing enabling technologies to complement and enhance implants and instrumentation, specifically focusing on pre-operative planning, imaging, smart instrumentation, and robotics. Enabling technologies are helping to standardize and improve care in multiple procedures, allowing clinicians to rally around the best surgical techniques and technologies.”

Indeed, there are plenty of rally sites from which to choose. Quite a large gathering has formed around extreme lateral interbody fusion (XLIF), a minimally invasive spinal procedure performed through the side of the body. Formed more than 20 years ago, this group is comprised of approximately 300,000 XLIF procedures, 200-plus educational courses, over 500 peer-reviewed publications, and more than 60 products, the latest of which premiered in August.

The ADIRA XLIF Plate System refines lateral plating by providing simplified insertion workflows and a rigid coupling mechanism. The solution is designed to align plates confidently over interbody spacers to enhance construct stability.

Launched by Globus Medical Inc., the system is compatible with bone screws and lateral minimally invasive surgical anchors, providing procedural versatility for bone fixation options as well as interbody spacer types. The ADIRA XLIF Plate System is compatible with the company’s lateral portfolio, as the plates are designed to rigidly thread into RISE-L, Modulus XLIF, Hedron L, Cohere XLIF, TransContinental, and CoRoent XLIF interbody spacers to help reduce the risk of spacer migration and accommodate various patient anatomies and surgeon preferences.

Using an alignment screw, the ADIRA XLIF Plates can be assembled to various lateral lumbar interbody fusion devices to create a plate spacer assembly that provides structural stability in skeletally mature patients after a discectomy. The plate-spacer assembly is used with bone screws and/or lateral anchors, and are filled with autograft and/or allogenic bone graft consisting of cancellous or corticocancellous bone.

“Many of today’s spine implants have moved from a single piece static component to multi-piece assemblies requiring moving parts meant for adjustments during their implantation procedure,” noted John Ruggieri, Senior VP of Business Development for Bloomfield Hills, Mich.-based ARCH Medical Solutions Corp., a precision machining, contract manufacturing, and supply chain integration resource for medical OEMs. “Small and intricate components fitting together in an extremely tight envelope require more than just the ability to make the individual pieces. Strong and scalable skill sets for assembly are required to effectively support an OEM for these types of implants. Capabilities for both additive and subtractive manufacturing provide customers with the options they need to address their product innovations.”

Additive manufacturing capabilities have been outpacing those of its counterpart in the last two decades amid the healthcare industry’s penchant for minimally invasive approaches, customized solutions, and creative product design. In orthopedics, additive manufacturing—a.k.a., 3D printing—has emerged as a transformative force, providing a precise means to implant development and fabrication.

3D printing technology specifically has spawned a profusion of spinal innovations since its birth nearly 30 years ago. Not only is it regularly used to create accurate surgical training models, it also is tapped to develop customized jigs used to design and produce patient-specific implants like interbody fusion cages and intervertebral discs.

Carlsmed’s aprevo implants, for example, are created using a patient’s medical imaging (X-rays, computed tomography) as well as proprietary algorithms that combine predictive analytics and prior outcomes data. The Carlsbad, Calif.-based company’s aprevo line of lumbar patient-specific interbody fusion devices for anterior, lateral, and transforaminal approaches received its second FDA breakthrough device designation last fall—three years after receiving its first breakthrough designation and FDA 510(k) clearance. aprevo is reportedly the first implant to receive both authorizations simultaneously.

The aprevo implants won Medicare coverage for spinal fusions this past summer and will be eligible for reimbursement starting Oct. 1. The devices earned the New Technology Add-On Payment by CMS and transitional pass-through payment in 2021.

Carlsmed’s customized aprevo devices are among the more recent innovations available to spine surgeons. However, the company itself is a relative newcomer to the orthopedic 3D printing arena compared to other implant makers.

Stryker has perhaps the most extensive 3D printing history, having worked with the technology since 2001. Its additive manufacturing process—dubbed AMagine—has enabled the orthopedic device behemoth to develop implants with geometries that were once “difficult or impossible” to manufacture.

Stryker conducts the research, development, and commercial launch of additive manufacturing technologies at its AMagine Institute in Anngrove (Cork County), Ireland. The 100,000-square-foot facility opened in 2016 and is complemented by a second 156,000-square-foot plant that came online in 2022.

“Stryker is a global leader in additive manufacturing, also known as 3D printing, technology development, and use,” Evans boasted. “We scaled the application of additive manufacturing…through our global AMagine Institute in Cork, Ireland, which explores and industrializes platform technologies to innovations in healthcare products in line with our mission. There is significant opportunity for continued innovation, specifically with patient-focused implants.”

Significant opportunities abound in implant design and surface treatments as well. Case in point: Stryker’s Tritanium In-Growth Technology is designed to mimic cancellous bone’s porous structure. The material features a random interconnected architecture with rugged, irregular pore shapes and sizes that can wick or retain fluid. According to Stryker data, Tritanium has a 55% to 65% mean porosity range and a 100μm to 700-μm pore range size.

Spineart SA’s 3D-printed bone-like matrix, Ti-LIFE, has a similar porosity—overall between 70% and 75%—and a 0.9-mm average pore diameter. Natural bone, by comparison, has a porosity that ranges from 70% to 95%, and a pore diameter spanning 0.3 mm to 1.5 mm, the Swiss company claims.

Spineart’s Ti-LIFE porous titanium technology is incorporated into both posterior and anterior spinal cage options. The JULIET line of posterior cages feature a smooth bullet-shaped self distracting nose and polished chamfer, which makes them easier to insert and distracts the intervertebral space while mitigating the risk of endplate, nerve root, and soft tissue damage. JULIET cages are manufactured in a wide range of options to address various patient anatomies and surgical approaches.

Ti-LIFE also is the main ingredient in the SCARLET AC-Ti secured anterior cervical cage, which won FDA 510(k) clearance in May. Building on a decade of experience with the SCARLET systsem, the SCARLET AC-Ti introduces new features such as the MIMETIX morphometric profile, developed with digital vertebral models to optimize the contact surface between the implant and endplates. The system’s three screws have a very sharp endtip with flutes and quadri threads for easy the insertion into the vertebra. The zero-profile, one-step locking mechanism with pre-assembled cam locks prevent screw migration.

“Creating implants like intramedullary nails, plates, and screws involves precise designs to meet specific requirements accurately,” stated Abraham Sayger, sales manager from the Hernando, Miss., location of Tegra Medical, a Franklin, Mass.-based contract manufacturer of finished medical devices and complex components including surgical instruments, needles, and implants. “3D manufacturing makes it possible to craft individualized implants tailored to each patients’ unique needs and intricate shapes that were once unachievable, through traditional methods.”

Camber Spine’s SPIRA Technology is not so much intricate as it is unique, at least compared to other implant manufacturers. Its proprietary SPIRA architecture uses an arch design to distribute load and create strength while minimizing titanium volume and allowing maximum space for through-bone growth.

Interbody cages with SPIRA Technology contain up to approximately 80% porosity and are structurally similar to trabecular bone. As the new bone forms through the cage, it grows onto and attaches to the implant surface, giving it better fixation than traditional cages that usually only have bony ingrowth at the endplates.

Camber’s latest SPIRA innovation, the SPIRA-A Integrated Fixation system, passed muster with the FDA in July. The anterior lumber interbody fusion device features an open matrix design to permit packing with autogenous and/or allogenous graft material to facilitate fusion, as well as additional fixation options to secure the implant in the disc space.

SPIRA-A Integrated offers a complete solution to the ALIF procedure, with integrated fixation deployed in a traditional ALIF cage and approach, as well as a windswept cage geometry for accessing L5-S1 with difficult vascular anatomy, and each implant offers up to 40 points of endplate contact.

The device contains three holes to insert bone screws or anchors for integrated fixation, as well as blocking screws to prevent fixation back-out. SPIRA-A’s screws and anchors have been designed to complement the cage’s performance, increase cortical endplate fixation, and provide 3D-printed anchors with a SPIRA Surface, designed to increase osseointegration potential and resist pull-out.

“3D printing allows manufacturers to create more innovative structures while controlling surface design. The ability to create biomimetic implants through different manufacturing techniques has given the surgeon community a better selection of implants for their patients.The future of spinal implants will be interest as manufacturers focus on better ways to address both the biomechanical and biological needs in spinal fusion,” Camber Spine CEO Brooks McAdam told ODT. “There is a lot of exciting innovation in the market focused on combining structure and surface in both the interbody and fixation space. I believe industry is in the early stages of innovation in this arena…”

One of the trailblazers in this arena is Precision Coatings Company, a Woonsocket, R.I.-based provider of proprietary coatings for medical applications, including single-use devices and reusable instruments and tools. The firm’s Ti360 surface technology deposits less than a 1 micron titanium layer on the surface of PEEK (polyether ether ketone)-based devices to improve osseointegration.

Ti360, is deposited with Precision Coatings’ ion beam assisted deposition technique, which combines concurrent ion beam bombardment with a low temperature PVD process in a high vacuum environment. In contrast to plasma spray techniques, this process reportedly obtains a much more robust bond and favorable surface geometry. Since PEEK’s hydrophobic nature leads to poor bone tissue attachment compared to titanium-based devices, Ti360 is ideal for orthopedic and spinal devices, particularly interbody cages.

“Many requests we receive require surface technology solutions to improve osseointegration on complex geometries that require limited impact to critical features,” noted Michael Gianfrancesco, the company’s vice president of engineering and technology. “At Precision Coating we are able to utilize our Ti360 to…improve osteointegration with little to no impact on critical features. Precision Coating also utilizes our NanoLaze technology to create custom surface textures to improve osseointegration. NanoLaze is a high-speed laser technology that can be programmed to create custom geometries on flat and contoured surfaces.”

“Customers are always looking for a surface technology to assist directly with osseointegration,” agreed Eric Manojlović, orthopedic sales manager, “which is why our ion beam-assisted deposition solution Ti360 is so critical in the orthopedic space.” 

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