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Increasing numbers of orthopedic companies are investing in digital solutions to change the way surgeons perform fusions, decompressions and disc replacements. Augmented reality (AR), artificial intelligence (AI) and surgical navigation make procedures more accurate, efficient and effective while allowing surgeons to safely maneuver through smaller incisions.
THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT® published by ORTHOWORLD noted that the number of orthopedic companies with navigation systems is more than double the number that market surgical robots. The report also stated that navigation could be a game-changing addition to spine surgery when coupled with AR and AI.
These technologies are pushing the limits of what’s possible in minimally invasive approaches and guiding surgeons to the next step in patient-centered care. “As navigation advances, so does spine surgery,” said Gabriel Jones, Co-Founder and CEO of Proprio. “Ongoing research and development efforts in the field of spine surgery technology are focused on refining and expanding the capabilities of navigation systems.”
The Benefits of Real-Time Decision-Making
In July, Proprio raised $43 million in series B funding to ramp up the commercialization of Paradigm, the company’s AI-driven navigation system. Paradigm employs light field technology to provide surgeons with 3D views of spinal anatomy. It captures and fuses high-definition images with preoperative scans of the patient’s anatomy.
The system is FDA-cleared for use during procedures performed on the spine’s thoracic, lumbar and sacral regions from a posterior approach. “These can range from common degenerative spinal conditions involving breakdown of the discs between vertebrae to various forms of scoliosis, tumors and trauma,” Jones explained.
Traditional treatments for these complex conditions rely less on real-time guidance and more on CT scans and other data about the patient gathered in the preoperative phase. Real-time visualization, in contrast, uses high-resolution imaging during surgery to improve the placement of critical devices — such as the implantation of pedicle screws — without compromising vertebrae integrity or risking spinal cord injury.
“Unlike existing navigation systems that rely on static preoperative imagery and physical markers, Paradigm observes the patient’s anatomy directly, offering a true representation of the entire surgical field,” Jones explained. “This approach redefines surgical precision, elevates patient outcomes and enables surgeons to make informed decisions with real-time, observed insights of the surgery’s progression.”
It can be difficult to provide surgeons with high-quality, real-time images during surgery, particularly when it comes to the speed necessary to deliver information for critical decision-making. “One major challenge lies in capturing and processing high volumes of intraoperative data without disrupting surgical workflows,” Jones said. “Paradigm tackles this issue with a sophisticated multi-camera array that captures high-resolution visuals of the surgical area.”
The system then fuses the captured imagery using advanced AI-driven algorithms that analyze the patient’s anatomy in real time. “This approach enables the technology to adapt with precise adjustments, accommodating variations and guiding surgeons to make informed decisions tailored to each patient,” Jones said.
Jones said that potential benefits of the Paradigm system include eliminating the need for high radiation intraoperative scans throughout procedures, which leads to a significant reduction in radiation exposure for the surgical team and shaves up to 30 minutes off procedure times; registration of the patient’s anatomy in seconds instead of 15 to 30 minutes that’s typical for conventional navigation systems; and the collection of 250GB of data per hour, a high volume of information that will drive the product development process in spine and inform advanced navigation models for future applications.
Paradigm is representative of efforts to enhance real-time visualization, precision and decision-making during surgeries. “By integrating artificial intelligence and machine learning, these systems can analyze complex data to optimize surgical strategies,” Jones said. “This evolving technology can further reduce complication rates, shorten recovery times and enable highly individualized surgical approaches.”
In March, Augmedics launched new features and indications for the xvision Spine System, reportedly the first FDA-cleared AR navigation platform for spine surgery in the U.S. The upgrades feature AI image enhancement and customizable imaging capabilities. It also includes FDA-cleared indications for nearly the entire spine, broadening the system’s applications to posterior cervical and pelvic surgical approaches, which are known to increase visualization difficulties for surgeons as they navigate around challenging anatomy.
Augmedics President and CEO Kevin Hykes said about 4,000 patients in 21 states have been treated with xvision since 2020. “The new indications mean more surgeons — and consequently more patients — are benefiting from the accuracy, precision and confidence that xvision navigation provides,” Hykes said. “We are also thrilled to launch our first application of AI, which represents the tip of the iceberg in terms of decision support and planning tools for surgeons. These new capabilities and indications are an exciting step into the future as we continue to revolutionize navigation.”
Spine surgeon Tyler G. Smith, M.D., founder of the Sierra Spine Institute in Roseville, California, performed his 50th case with the xvision platform in March. “The AI-enhanced 3D models of patient anatomy and 2D intraoperative images provided by the system are transformative in terms of visualization,” he said. “The new lateral x-ray view is an excellent tool for seamless alignment of tulip head pedicle screws.”
In June, Augmedics raised $82.5 million in series D funding to increase the adoption of AR navigation in spine surgery. The technology superimposes patient and clinical data onto the surgical field and allows surgeons to visualize anatomy through the patient’s skin while navigating instruments and placing implants. Surgeons can always keep their focus on the patient, a factor that contributes to improved visualization and potentially improves outcomes.
In July, Augmedics further strengthened its AI and AR portfolio by acquiring Surgalign’s digital assets, including the Holo Surgical technology.
Hykes believes the funding and acquisition of advanced, AR-driven technology will ultimately allow for a bigger expansion into orthopedics and has the potential to increase Augmedics’ commercial footprint, a development that will lead to a wider-scale adoption of navigation in spine.
Looking Ahead to a Transformative Future
Orthopedic companies are investing in the assumption that the increased digitization of spine surgery will lead to more minimally invasive techniques, shape the future of personalized patient care and improve outcomes in the form of less post-op pain and shorter recoveries.
Several new companies are recognizing the segment’s potential and entering the spine navigation market, including Paris-based SMAIO.
This past summer, the company received its first FDA clearance for customized procedure planning software in partnership with NuVasive. It also held its first-ever training program in the U.S., where spine surgeons from around the country were introduced to SMAIO’s technology.
“We believe that surgeons will soon benefit from our cutting-edge solution for planning and performing patient-specific surgery and ultimately improving patient outcomes,” said Philippe Roussouly, SMAIO CEO.
Navigation platforms can improve reproducibility and surgical workflows, both of which have become vital factors in spine care, especially as more procedures shift to the outpatient setting.
“Specific spine cases — typically anterior cervical fusions — are moving from hospitals to ASCs,” Jones said. “The use of navigation is not yet standard practice for these procedures, even though the technology can deliver unique value in terms of safer and more effective surgery.”
Newer, more advanced navigation has the potential to provide more and better options for patients as spine surgery continues to evolve. For example, disc replacement surgery involving motion-preserving implants is becoming a popular alternative to spinal fusion for the treatment of common issues like degenerative disc disease and disc herniation. Innovations in implant design also continue to produce better patient outcomes, with many surgeons counting on hardware advancements to drive the future of spine health. Navigation technology can help surgeons place these implants more precisely.
Jones believes that the emphasis for product development teams will eventually shift toward focusing on technology that helps to facilitate implant placement and patient care. “This shift is particularly evident as startups and early-stage companies carve out unique differentiators that attract the attention of established companies seeking innovation,” he explained, “The goal is to enhance procedures without imposing significant changes on surgeons, allowing them to maintain or even enhance their patient-specific surgical techniques.”
Jones anticipates a significant increase in the use of enabling technology in spine surgery over the next five years. He predicts that surgeons will leverage navigation platforms to enhance their clinical decision-making, while also incorporating it into the training of new surgeons.
As research progresses and more advances are made to navigation technology, a continuous stream of innovations will revolutionize the future of spine surgery by empowering surgeons with unprecedented imaging capabilities and intraoperative decision-making tools.
“These factors will level the playing field in the operating room, enabling novice surgeons to achieve surgical accuracy comparable to their more experienced counterparts,” Jones said. “The emergence of advancing technologies will usher in a transformative era for spine surgery, characterized by heightened precision, individualized patient care and a thriving ecosystem of innovation that benefits surgeons and patients.”
Dr. Patel uses the PathKeeper System, which allows surgeons to place pedicle screws with pinpoint accuracy and features a small footprint well-suited for use in ASCs.
Surgeon Sings the Praises of Navigation
Tushar Patel, M.D., debuted the PathKeeper System during two lumbar spinal fusions performed in July at VHC Health in Arlington, Virginia. The 3D optical-guided navigation solution from PathKeeper Surgical in Israel allowed him to track the patients’ anatomy and his instruments with “pinpoint precision.”
PathKeeper’s 3D optical navigation, a key feature of the platform, provides active and independent tracking capabilities with an accuracy of less than a millimeter. The system’s navigation software and 3D optical camera help surgeons precisely locate anatomical structures and place pedicle screws in the thoracic, lumbar and sacral regions during posterior lumbar interbody fusion.
PathKeeper features a compact footprint and provides registration of anatomy in seconds without the need for intraoperative imaging and associated radiation exposure risks to the surgical team.
With an eye on commercializing the system in the U.S., PathKeeper has been launching surgical showcases with built-in training for spine surgeons who are interested in using the technology for the first time. As a result, complex spine surgeries involving the system have taken place at St. Vincent’s Medical Center in Bridgeport, Connecticut.
Glenn S. Russo, M.D., was one of the St. Vincent’s surgeons who used the 3D optics technology for the first time and claimed the experience convinced him to reassign some of his spine cases to outpatient facilities. “The system allowed me to safely navigate spinal implant placement,” he said. “This imaging technology is particularly exciting with growing applications in minimally invasive surgery.”
