A new surgical robot is smaller, nimbler, and cheaper, its maker claims. But will it be better for patients?

The surgical robot market, long dominated by one company, has a new entrant hoping to disrupt the industry with a more immersive, 3D experience for surgeons — even as the need for surgical robots in most procedures remains hotly debated.

Robot-assisted surgery has boomed in the past 20 years, led by Intuitive, the company that makes the popular da Vinci robot. Vicarious Surgical, the new company that went public last month, claims it can do better than what exists on the market — “legacy systems,” as co-founder and roboticist Adam Sachs refers to them, declining to critique Intuitive specifically. “I’d prefer to leave the criticism of Intuitive to, you know, hospitals and surgeons,” he said.

By pairing a smaller, more flexible robot with virtual reality technology and 28 sensors on each arm, the Vicarious robot allows surgeons, said Sachs, to feel as if they are inside a patient, looking and moving around with more control. “Because now we’re building robots that operate from inside the abdomen instead of across the abdominal wall, we have the ability to actually make those arms work like a human arm, naturally work like the surgeon’s arm, and have the ability to have a camera that can actually follow the motion of the surgeon’s head,” he said.

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To Sherry Glied, a health policy expert who has studied robot-assisted surgery, “it sounds like a ride at Disneyland.” But she cautioned that the technology is still unproven. “I would say the jury is still out, really, as to whether the robotic surgeries that we’ve been doing for 20 years have been, including all of their effects, better than the surgeries that they replaced,” said Glied, an economist and dean of New York University’s Robert F. Wagner Graduate School of Public Service.

In a 2010 paper in the New England Journal of Medicine, Glied and co-author Gabriel I. Barbash said the lack of “well-designed, large-scale, multicenter trials” meant clinicians didn’t have clear guidance on when robot-assisted surgeries were appropriate or not. In the 11 years since, that hasn’t changed, Glied said. No medical consensus has emerged, but robotic surgery has nonetheless mushroomed. Some studies suggest certain robotic surgeries have the same outcomes as other methods but cost more. Other studies say robots are beneficial in certain cases.

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There are nearly 6,000 da Vinci machines globally, and more than 8.5 million procedures were done with the robots in 2020 alone, according to Intuitive.

The robots are used as an alternative to open surgeries, which often require larger incisions and more invasive handiwork, and to laparoscopic tools that are less invasive but also less nimble. Prostate surgeons were among the first to wade into the world of robot-assisted surgery, and have increasingly turned to the less invasive robotic procedures for the delicate, walnut-sized organ.

The robots, which look something like praying mantises with lights for eyes, have “wrists” on their instrument hands, giving them a wider range of motion than is available in laparoscopy. And robots can help surgeons perform delicate tasks that are harder to do without them, like detailed dissections and sewing.

Arielle Perez, a surgeon at the University of North Carolina’s Hernia Center, describes laparoscopic surgery as trying to complete a task with an arm cast on, only able to use one’s fingers, versus if “you took the cast off and you could work with your entire hand, and you have those degrees of freedom.” (Perez is paid by Intuitive for teaching other surgeons how to use the company’s robots.)

When Waltham, Mass.-based Vicarious was listed on the New York Stock Exchange last month, after merging with D8, a special purpose acquisition company, it said it hoped to take in about $220 million in gross proceeds to carry the company through the Food and Drug Administration approval process. It plans to file for FDA clearance in late 2023, Sachs said.

If its technology is cleared, Vicarious plans to roll out a flagship program for hernia repair in the next few years, followed by other kinds of surgeries later on. By starting off with hernia surgery, Vicarious can tap into a corner of the U.S. market that hasn’t widely adopted robots yet, Sachs said. He sees it as an opportunity to start small and build, instead of trying to tackle procedures that already use robots.

The robot was given Breakthrough Device Designation by the FDA, in part based on early data that showed Vicarious’s robot-assisted hernia technique might be able to reduce recurrence rates from 20% to 4%, according to Sachs.

But some surgeons are skeptical of this unpublished data. “There isn’t a huge amount of data supporting robotics use in hernias in general,” said Benjamin Davies, a professor of urology at the University of Pittsburgh School of Medicine and chief of the urology section at the university’s Shadyside/Hillman Cancer Center. Davies said he has performed thousands of robot-assisted surgeries with da Vinci models over a dozen years. He considers the recurrence rates Vicarious touts to be “totally baseless” without a clinical trial. “I will be a nonbeliever until it’s done.”

Davies said more recent iterations of the da Vinci robot have addressed some of the early issues the machines had, such as being clunky and large or needing multiple ports to enter the body. Now, the da Vinci is able to do a single-port surgery and move around in ways Vicarious says its competitor cannot. “All those things we struggled with initially have really gone away,” Davies said of the da Vinci.

Sachs said through a spokesperson that Vicarious will work closely with the FDA “to follow their required path for clearance,” which could include a trial. Medical devices are not regulated in the same way as drugs, which manufacturers must prove are safe and effective, often by comparing them in a clinical trial with a placebo or the standard of care. The robots don’t need to be proven to work better than laparoscopic or open surgery in order to be approved by regulatory agencies, so device trials don’t usually happen before they are used in hospitals and in patients.

Perez, the UNC hernia specialist, said she was “slow to adopt” robotic techniques but it is now on the menu of options for her patients. For people with thicker abdominal walls, previous surgeries, or larger or more complex hernias, she tends to favor robotic sturdiness, dexterity and specificity. For straightforward cases, laparoscopy is sufficient, she said.

Perez said she would be willing to try out the Vicarious robot.

“If it does allow you to get a wider view of the tissues, it’ll reduce how much you have to move a camera around and it could be very beneficial,” she said. “Until you try it out, it’ll be hard to say.”

What is known about surgical robots is that they are expensive (a Vicarious robot will cost about $1.2 million, Sachs estimates, compared to about $2 million for the da Vinci), and can significantly raise the price of surgeries. That allows hospitals to quickly recoup the cost of the technology, but it can equate to an added cost burden for patients and payers.

Some studies argue that extra costs in the operating room can be offset by cost savings after surgery, when patients can recover and be discharged more quickly. On a larger scale, Vicarious entering the marketplace with a robot to compete with the da Vinci could also help drive down costs for such surgeries, Glied said.

Sachs said his vision for Vicarious is a platform that can halve the procedural time and double the revenue for hospitals and surgeons.

Health care providers might go for that sales pitch, even if they have another robot already, Glied said.

“If they think that they can sell it to more customers, they will buy the new robot,” she told STAT. “Or if they can attract new, hot shot surgeons who will attract new customers, they will go with the robot if it looks shinier in their ads.” Marketing and clinical and fiscal results – “all three of those things together will be what influences the hospital’s decision, ultimately.”

For the next year, Vicarious will be beta testing its robot, consulting with surgeons to nail down the details of the machine and platform and finalizing device features before filing for FDA clearance in late 2023, Sachs said.

Source: STAT