Since the introduction of the da Vinci surgical system nearly 20 years ago, robotics has revolutionized surgery for patients undergoing everything from hysterectomies to coronary bypasses. The promise of this technology has finally arrived for spine surgery.
Medical device companies are debuting a new collection of robotic-assisted tools designed to help surgeons improve the precision, safety and consistency of complex spine procedures.
Today, few spine surgeons use robotic-assisted technology in the operating room, but that’s expected to change due to the rapid development of this technology as well as the rising demand for minimally invasive back surgery among aging Americans. The spinal robotics market is projected to grow to $320 million by 2026, according to a 2019 report by Transparency Market Research. A 2016 survey by RBC Capital Markets revealed that more than one in four spine surgeries could be performed using a surgical robotic system within the next decade.
The use of robotics in surgery has evolved significantly since the release of the da Vinci robot in 2000. The da Vinci is an active robot with arms attached to a 3D camera and surgical instruments inside the patient’s body that are manipulated by a surgeon across the room. It was initially approved for general laparoscopic surgery, but it is now widely used in urologic, gynecologic, cardiac, colorectal and thoracic procedures.
Innovators began experimenting with robotic technologies for orthopedic surgeries nearly 15 years ago with the release of navigation-based systems such as the MAKO robotic arm. First primarily used for joint replacement procedures, robotics for spine surgery has begun developing more rapidly in recent years.
How Spine Robots Work
Spine robots act as guides, helping surgeons position their tools for the precise placement of screws and implants. Associated software produces virtual 3D images of a patient’s spine from CT and MRI scans. This enables surgeons to map out details of the surgery in advance—from the right size of instruments to the best trajectory for inserting hardware into bone.
During surgery, these platforms work like a GPS, allowing surgeons to track their instruments against virtual landmarks of the patient’s spine and make precise calculations about next steps. A robotic arm, mounted to the operating table or the patient’s vertebrae, syncs with a digital blueprint of the surgical plan and guides surgeons as they place screws and implants into the spine. If the patient breathes or moves slightly, most robots can sense changes in position and adjust accordingly.
This technology improves accuracy and safety during surgery and reduces the amount of imaging required throughout the procedure, decreasing radiation exposure for patients and operating room staff. These robotic tools can also help make spine surgeries more efficient and successful, especially in minimally invasive procedures.
“One of the biggest challenges in spine surgery is reproducibility,” says Brent Ford, clinical director, HealthTrust inSight Advisory–Medical Device Management. “Surgeons want to use their instruments and implants in a comparable manner and without change to that cadence. But that can be hard when operating on patients with so many different kinds of physiques and anatomies.”
The navigational expertise of these systems can help surgeons improve planning, prepare for challenges they may face during surgery and develop more of a streamlined process for each procedure. “This helps surgeons avoid obstacles that can slow them down and provides support in the final stretch of surgery,” Ford says.
Several companies are vying for market share in the spine robotics space, but the most prominent is Mazor Robotics, an Israeli-based firm purchased by Medtronic in 2018 for $1.6 billion. In 2004, the company introduced SpineAssist, the first robotic-assisted platform for spine surgery, followed by a more sophisticated Renaissance Guidance System for spine and brain surgery in 2011. Mazor and Medtronic formed a strategic alliance in 2016 to develop the Mazor X, which combined its robotic navigation capabilities with analytical tools, precision guidance, optical tracking and intraoperative verification.
In January 2019, Medtronic launched the Mazor X Stealth Edition, designed to help surgeons visualize and plan robotic spine procedures beforehand and execute them with increased predictability and precision.
Another anticipated innovator is Globus Medical, whose robotic navigation platform ExcelsiusGPS was conceived by Johns Hopkins neurosurgeon Theodore White for minimally invasive spine procedures. Like many surgeons, White relied on multiple X-rays taken during surgery to place screws with minimal incisions and adjustments. Noticing how his hands tended to drift when looking to images on the screen for guidance, White began using a touch screen to plan the best pathway for screw placement and a robotic arm for the execution.
Other leading spinal robotics developers include Zimmer Biomet, which acquired its robotic navigation technology from the French firm Medtech and recently received FDA approval for its ROSA One Spine platform; Johnson & Johnson’s DePuy Synthes, which is working with Google’s life sciences unit to bring greater visualization, instrumentation, data analytics, machine learning and connectivity to robotic surgery capabilities; and Stryker, which is expected to eventually adapt its MAKO robot for spine surgery.
Over the next few years, many of the current systems on the market will become less cumbersome and more efficient—and many are already implant-agnostic, which adds to their ease and flexibility, Ford says. This summer, HealthTrust showcased demonstrations of these top platforms at its annual cadaver lab for member executives.
“We wanted to provide members with a comparison of these technologies to help them learn more about this market, why their physicians are asking about it, and what distinguishes one platform from another,” Ford explains.
Though early clinical trials of these navigational tools have shown potential for reducing human error and patient complications compared to freehand and fluoroscopic surgical techniques, investing in spine robotics at this stage is a bit of a gamble for many hospitals because of the expense and training required for proper implementation. But it makes sense for hospitals to start learning about this technology now so they can be competitive in the future, Ford notes.
“Everyone is curious about spine robotics,” he says. “Physicians want to learn more about bringing it into their facilities, so they can be cutting-edge. Patients are also more educated and may look to choose a hospital based on its ability to offer access to technologies like these.”
2000: Intuitive Surgical releases the da Vinci robot, the world’s first robotic-assisted surgical system, for use in general laparoscopic procedures.
2004: Mazor Robotics introduces SpineAssist, the first robotic-assisted platform for spine surgery, and receives FDA approval to market it in the United States.
2011: Mazor Robotics releases a more sophisticated navigation-based robotics system for spine and brain surgeries.
2013: Stryker buys MAKO Surgical, acquiring its MAKO Rio robot for partial knee and total hip replacements and increasing robotics in the orthopedic market.
2016: Mazor Robotics launches its Mazor X system for spine procedures, distributed by Medtronic; Zimmer Biomet acquires Medtech with plans to adapt its robotics navigation and preplanning technology from brain surgery to spine procedures.
2017: Globus Medical receives FDA approval for its robotics navigation platform for spine surgery, ExcelsiusGPS, initially developed by a Johns Hopkins neurosurgeon.
2018: Medtronic acquires Mazor Robotics and releases the Mazor Stealth to improve the precision and predictability of its spine robotics platform.
2019: Zimmer Biomet receives FDA approval for its ROSA ONE Spine platform for minimally invasive spine surgeries.