Not a Moment Too Soon: FDA Clears Intuitive Surgical's New Robot

In what could be called a turning point for robotic surgery, FDA has cleared da Vinci 5, the latest surgical robotics system from market pioneer Intuitive Surgical.

Intuitive's investors had been growing restless for news of a new multiport da Vinci system until three weeks ago, when CEO Gary Guthart confirmed that the company has been quietly working through the FDA process for the da Vinci 5.

The company is expected to discuss the da Vinci 5 features and benefits, along with launch plans, during a conference call Monday morning. In the meantime, here is what we know about the new robot:

Only select robotic surgeons will have access to da Vinci 5 for some time

Intuitive Surgical's da Vinci 5 tower. IMAGE COURTESY OF INTUITIVE SURGICAL

Intuitive said the da Vinci 5 will initially be available only to a small number of U.S. customers who collaborated with the company during the development period and to those with mature robotic surgery programs. This limited launch will enable the company to work with its early adopters to generate additional data on the system's use before a wider commercial introduction.

"We strive to provide customers with technology that meets their needs and solves important problems," said Myriam Curet, MD, chief medical officer at Intuitive Surgical. "We intend to launch da Vinci 5 more broadly in the U.S. and globally after we learn from and work with an initial smaller number of customers directly.

Related:The Moment Intuitive Surgical Investors Have Waited For

Intuitive has designed da Vinci 5 with a whopping 150 enhancements

At the J.P. Morgan Healthcare Conference in January, Guthart said the company would not rush a new system to market without making a meaningful change to the technology. With a whopping 150 enhancements, it seems he was serious about that commitment.

“Intuitive is committed to meaningful improvements in surgery that enable better patient outcomes, enhance the patient and care team experiences, and ultimately lower the total cost of care. After more than a decade of careful research, design, development, and testing, we believe da Vinci 5 will deliver on these goals and help drive the future of robotic-assisted surgery," Guthart said.

The enhancements, according to the company, include:

What medtech analysts are saying about da Vinci 5

William Blair's Brandon Vazquez said in a report issued early Friday morning that he is bullish on long-term growth potential based on his initial read on the da Vinci 5 announcement.

First, based on his team's November 2023 survey, Vazquez said the da Vinci 5 checks the box of at least three of the top four most requested features by bariatric surgeons (the analyst notes these surgeons are largely representative of general surgery use cases). Those three boxes are decreased footprint, haptic feedback, and console ergonomics.

"We think this can help drive incremental demand for the system and raise the bar for competition in the future," Vazquez wrote.

Intuitive's da Vinci 5 has integrated key OR technologies, including insufflation (shown here) and an electrosurgical unit. IMAGE COURTESY OF INTUITIVE SURGICAL

The analyst also said a streamlined workflow with da Vinci 5's integrated insufflation and electrosurgical units, as well as new heads-up displays, can potentially reduce procedure times and the cost of each procedure. These benefits in turn can incentivize hospitals to convert additional surgical volumes to da Vinci, Vazquez wrote.

BTIG's Ryan Zimmerman raised some interesting questions regarding da Vinci 5 (Dv5) potential to move the needle.

"If Dv5 can speed up procedures this would create additional capacity and drive I&A sales higher," Zimmerman wrote in his report, issued Thursday evening. "We know the Dv5 computing power will be leaps ahead of Xi and feedback is starting to emerge from a few KOLs, but there is only so much time in the day and no matter how smart a robot may be, humans can only prep an OR so fast or turn around an OR regardless of technology."

To gain better insight into the utilization factor, Zimmerman and team conducted an interesting analysis on Intuitive Surgical’s utilization rate (procedures per system per quarter), which has steadily increased over the past couple decades. The analyst estimates that Intuitive is currently averaging about 70 procedures per system per quarter. The analysis assumes one da Vinci unit per operating room and roughly 91.25 total days per quarter.

“When we think about capacity in an operating room, we consider the following items as key factors: operating room hours in a day, operational days per quarter, and average procedure times,” Zimmerman wrote. “...The first three are flexible. Facilities can run operating rooms longer in a given day, a facility could add on cases during the weekend, or case times could go faster (a result of [the company’s] efforts to improve workflow efficiency) and one of the biggest drivers to achieving increased ROIC for hospital customers."

So, what did BTIG's analysis show?

“In short, we believe [Intuitive Surgical] has a lot of headroom to keep growing utilization,” Zimmerman wrote.

The analyst added that even under conservative assumptions, he sees capacity per operating room well ahead of current utilization.