Spine surgery has advanced significantly over the past decade, with minimally invasive surgery and robotic spine surgery drawing increased interest from surgeons.
In 2004, The FDA approved the Mazor SpineAssist for the placement of pedicle screws. The technology has developed rapidly since then, with several device companies introducing their own robots with promising clinical outcomes.
Currently, the technology is approved for pedicle screw placement but could soon expand to other areas of spine.
Here are 17 notes for surgeons, ASCs and administrators:
1. Market growth. The global spinal robotics market value is expected to reach $320 million by 2026, up from $75 million in 2017. Market growth will be driven by increased demand for minimally invasive spine procedures, which robots support.
2. Robots are here to stay. Interest continues to grow in reduced radiation exposure for patients and staff, precise implant placement and minimally invasive technologies. While robotic technology "may not be optimal, it has reached a point where it is reasonable and available," said Jonathan Carmouche, MD, of Carilion Clinic in Roanoke, Va.
3. Cost. Robotics are expensive purchases. Globus Medical's ExcelsiusGPS costs $1.5 million and Medtronic's Mazor X robot costs more than $1 million, with added disposable costs of about $1,000 per case, according to a study published in the Journal of Spine Surgery. The high cost ultimately increases the cost of care for patients. However, as the healthcare industry continues its move away from fee-for-service toward a value-based care model, device companies are working on producing robots that are less expensive.
"Robotics are going to have to get cheaper so that your quality of care, global fees and episodes of care can be reasonably done and reasonably charged," said Stephen Hochschuler, MD, founder of Texas Back Institute in Plano. When we consider more cost-effective options to care, device companies believe that the increased precision provided by robots will lead to fewer surgical errors and less reoperations, therefore leading to lower costs in the long term.
4. Attracting top surgeons. The next generation of spine surgeons want to have access to the latest and greatest technology on the market. For total joint and spine surgeons, that's robotics, according to Alfonso del Granado, administrator at a Texas surgery center. Although robots can be an expensive capital purchase, surgery centers "have to make the investment" to attract talent at the top of the surgeon pool, he said.
5. Advantages/disadvantages: Although still in its infancy, robotic spine surgery has well-documented benefits. Improved precision translates to better outcomes and quicker recoveries for patients, smaller incisions mean smaller scars and reduced risk of infection, and robots contribute to less radiation exposure for patients and staff. Robots can help surgeons safely transition to more minimally invasive procedures while maintaining low reoperation rates. Disadvantages include high costs, steep learning curves and inherent technological glitches.
6. Future applications. While robots are primarily used for pedicle screw placement, the technology has the potential to advance far beyond instrumentation placement. "The future is very exciting for robotic spine surgery," said K. Samer Shamieh, MD, of Avala Hospital in Covington, La. "I believe that robots will soon be used for docking of retractors, drilling of bone as well as directing certain equipment to take away tissue from the spinal cord and nerves."
7. Spinal deformity surgery could be the next frontier for robotics. "Planning lumbar laminectomies and more technically demanding techniques, like osteotomies for deformity surgery," are on the horizon, according to Raymond Walkup, MD, of Polaris Spine & Neurosurgery Center in Sandy Springs, Ga. "Soon, we will have the ability to plan the deformity correction and predict the amount of lordosis we can achieve with the fusion construct."
8. Robotic autonomy. While many physicians believe that robots will never replace surgeons, other industry leaders see the technology developing greater autonomy in the operating room, similar to robots in the auto industry.
9-12. A breakdown of spinal robotics at four device companies:
Medtronic: In December 2018, Medtronic acquired Mazor Robotics in a $1.7 billion deal, as part of its plan to combine its spinal implants, navigation and 3D-imaging technology with the Mazor X robotic guidance system. The Mazor X costs about $1 million with each surgery resulting in about $1,500 in disposables sales. The third-generation system, the Mazor X Stealth Edition, was used in more than 1,000 procedures in over 50 U.S. hospitals in its first year.
Globus Medical: Globus Medical acquired Excelsius in 2014 for an estimated $40 million and earned CE Mark approval for ExcelsiusGPS in the European Union in January 2017. The FDA cleared the system for use in spine surgery in August 2017. ExcelsiusGPS is priced at about $1.5 million and supports screw placement in several approaches including posterior cervical, posterior thoracic sacroiliac and posterior lumbar.
Zimmer Biomet: In 2016, Zimmer Biomet acquired Medtech SA for at least $132 million. Medtech developed the Rosa Brain and Rosa Spine robotic-assisted surgery systems, which cost about $700,000 each. Rosa Spine was cleared by the FDA in 2016, but the company's new technology — the Rosa One Spine System — received FDA approval in March 2019. The Rosa system has been used more in cranial neurosurgical procedures than in spinal procedures.
NuVasive: NuVasive revealed a new spinal robotics system called Pulse in the fall of 2019. The robot is an open imaging platform integrated with Siemens' 3D mobile C-arm, Cios Spine. The Pulse system is expected to have applications for all spinal surgeries, not just complex or low-acuity cases. The system features neuromonitoring, surgical planning, radiation reduction and rod bending technologies, as well as imaging and navigation functions. CEO Chris Barry said in NuVasive's second-quarter earnings call that robot has been delayed due to "software and hardware updates following beta testing, as well as the impact of COVID-19." The Pulse system is expected to launch in summer 2022, with the first-in-human use of Pulse Robotics in 2022.
13-17. Five surgeon insights:
Christopher Good, MD. Virginia Spine Institute (Reston): "Spinal robots have already advanced well beyond being used solely for instrumentation placement. I have used robotic software and guidance to help plan and execute osteotomies for spinal realignment and to guide spinal decompression. I also use robotic guidance to assist with minimally invasive lumbar facet preparation in the setting of minimally invasive fusion. I've also used robotic/navigation guidance for pelvic reconstruction and sacroiliac joint fusion. I believe the next big advancement will be using robotic guidance to prepare the interbody space for fusion and also to perform fully automated robotic-guided laminectomy/decompression."
Kornelis Poelstra, MD, PhD. The Robotic Spine Institute of Silicon Valley (Los Gatos, Calif.): "The future for robotics is bright. In addition to trajectory guidance to place hardware and perform complex preoperative planning procedures, robots are soon going to be able to have greater autonomy in the OR, I hope. We must discuss these advances together with regulatory bodies such as the FDA, but this autonomy will not be far off. Robotic systems should be able to nearly autonomously place hardware, further reducing outliers and human error, help us with discectomy procedures and end plate preparation in a more predictable form as well as with decompression surgery or the spinal canal.
"Utilizing advanced learning, I am confident that we can start manipulating muscle and fascia and have robotic assistance that will help us open and close surgical approaches. People should also not forget the highly advanced predictive analytics that help us with the decision-making processes of which surgical technique to offer to which patient. Robotic and computer systems are much more capable of analyzing large amounts of variables to help us reduce complications and make better choices for our patient population."
Brian Gantwerker, MD. Craniospinal Center of Los Angeles: "In a year, the spine space will be more crowded in terms of robotics and endoscopy. We anticipate a larger market share being taken from Medtronic/Mazor and going toward DePuy and Nuvasive. There will be larger patient demand for minimally invasive outpatient and awake surgeries."
Christopher Blanchard, DO. Resurgens Orthopaedics (Atlanta): "Robotics in spine surgery is still in its infancy compared to robotics in general surgery. Currently, the largest utility of a robot is with screw placement. This is rapidly changing with software and hardware updates. In the next five years, I think robotics will continue to evolve, allowing surgeons to perform surgery in a less invasive way to allow for quicker recovery. I believe as robotics develops, it may completely change how we think about and perform spinal procedures."
Vladimir Sinkov, MD. Sinkov Spine Center (Las Vegas): "I am excited about new technologies in spine surgery that will lead to better patient outcomes, faster recovery and lower chance of complications. These technologies that enable minimally invasive spine surgery, robotic assisted surgery, computer navigation and augmented reality bring with them extra costs. The financial savings associated with minimally invasive spine surgery result in faster recovery and return to work and function, shorter hospitalization or even avoiding an admission altogether. Lower chance of complications or need for revision surgery will more than compensate for such extra expenses. Once the technologies are widely implemented, the costs will inevitably go down while we continue to provide the best and most innovative care for our patients."