Officials at the world’s largest medical device company think their Mazor X Stealth robot-assisted spinal surgical platform could move complex procedures from an art to a science.
The company late last year closed on its $1.7 billion purchase of Mazor Robotics and its robot-assisted surgery platform for the spine. A month later, Medtronic launched its Mazor X Stealth robotic-assisted spinal surgical platform in the U.S.
The Mazor X Stealth combines robotic guidance system technology from the Mazor acquisition with Medtronic’s StealthStation surgical navigation technology.
Dave Anderson, VP and general manager of enabling technologies at Medtronic, recently spoke with Medical Design & Outsourcing about how the Mazor X Stealth could greatly improve spine surgery outcomes.
MDO: Why is it important for Medtronic to compete in the robot-assisted orthopedic surgery space?
Anderson: It’s really about improving outcomes. If you take spine in particular, for example, you can see over the past decades that it hasn’t been as predictable as we want. It’s complex. So how do we move complex procedures to be really predictable, moving them from art to science? How do we simplify them? All those things are what robotics can bring us. … In many procedure types, and spine being a classic example, there’s been a lot of innovation, but outcomes aren’t where we need them to be. That plays into the opioid crisis as well — as failed back surgery causes pain which then causes, unfortunately, the opioid crisis that we’re facing.
MDO: Medtronic’s Mazor X Stealth system — how is it able to, as you said, move complex procedures from an art to a science?
Anderson: Prior to even going into the procedure, you can look at the construct, look at what your goal is, plan precisely where you want to place your screws, how your rod is going to be oriented to achieve the biomechanics that you’re looking for. And then in your procedure, you execute that plan with robotics. So now you have the precision to know you’re exactly performing the plan as intended to get the outcomes you were striving for. That’s the robotics side. What [StealthStation] navigation brings is the ability to confirm along the way that you are doing exactly what you intended to do and to visualize that. … That combination is what improves outcomes.
MDO: What is the surgeon doing in the procedure versus the robot?
Anderson: Today, what the robotic portion is doing is setting up the trajectory so you have an end effector on the robot that moves to the preplanned position and creates a trajectory that the physician can then place a pedicle screw through to ensure that it’s going in the right location, the right angle, and by combining with navigation, you’re able to visualize the pedicle screw on the screen to show it’s going to exactly the right location and depth. Then the robot will automatically move to the next position, and you’ll be able to move from position to position and execute all the pedicle screw placement that was planned.
Down the road we’ll incorporate more pieces of the procedure such as interbody placement, bone cutting, etc. to also be robot-assisted.
MDO: How does this guarantee consistency of the procedures? How is that able to happen?
Anderson: So let’s start with a deformity case, one of our complex procedures. You have the correction that you’re looking to achieve, and you need to know, “Where do I precisely place these screws and rods so that it straightens the spine to achieve the outcome I want?” And you’re actually able to look at the forces that would cause the actual correction that would be achieved, and so from a computer-planning perspective you’re pre-deciding what’s going to happen and the outcome that will occur. Then you execute that plan robotically.
In an open procedure, imagine that you’re doing that same thing, but you don’t have a plan. You’re just in a sense visually looking at the patient and making decisions on a level by level basis that your experience and history would leave you to believe would come to a certain outcome, but there’s much less certainty and predictability as when you create that plan in advance and then execute it.
MDO: What kind of evidence have you been able to gather so far to demonstrate that this is an improvement postoperatively over what was done before?
Anderson: We’re still early in our evidence. … We just launched the Stealth Edition. What I can say is from prior generation products, including the [Mazor X guidance system and the Renaissance robot-assisted spine surgery device] before that, we do have publications, peer-reviewed, that talk about pedicle screw accuracy and show the significant improvement in the accuracy of placement versus in freehand. One of the publications also shows a six times risk reduction in the need for revision surgery. So the risk of revision surgery has been reduced sixfold. … With the Stealth edition, because we just launched it, we have prospective studies planned. Over time we’ll be able to publish even stronger outcomes. If I were to look at our roadmap for the future, for example, we have a goal of reducing OR time by 40%, and that’s something that we plan to study and publish. … Our goal is to have a range of study types.
MDO: So where do you want to take this next?
Anderson: Our next big step is how do we make each of these steps work seamlessly together, work better together when you use the whole ecosystem. That’s the whole strategic focus for us.
We have a broad swath of procedures that we support even today. But how do we improve specific steps of the procedure using robotics? And that’s where we can talk about more of our future features. I mentioned bone-cutting as an example, so that’s a procedural step and depending on the procedure you may have more or less bone-cutting required. Disc removal is another example, again depending on the procedure. So as we think about the future, it’s really about how do we look at all the steps for all the procedures, where can we add the most value, where can we move from unpredictable to predictable and really save time and improve outcomes for our physicians?
MDO: A robotic system can be pretty expensive. How do the economics work for health providers?
Anderson: It’s a high-cost capital item. That being said, if we look at the goal of reducing OR time by 40% or we believe we can reduce total procedural costs across all the steps by 10%, you can start to pretty quickly look at the reimbursement levels of spine, the cost of those procedures, the quantity of procedures performed. You can see how it can drive economics pretty quickly with that once you’re able to utilize at the levels we’re looking to utilize.
MDO: How much interest are you getting in the Mazor system?
Anderson: Interest is really high. Because we’re early in adoption, there’s still a minority of total centers that have this equipment. There’s very high interest, but … many that are evaluating right now when they’ll move with a robotic system. So very high interest, still early in the adoption curve in terms of how many centers currently have a robot.