Intuitive Surgical Receives FDA Approval for New da Vinci Xi

RBR50 company Intuitive Surgical has received clearance from the Food and Drug Administration (FDA) for the da Vinci Xi, its fourth-generation surgical robot for minimally-invasive procedures.

With the U.S. introduction underway, Intuitive will seek regulatory clearance to market the da Vinci Xi worldwide. Bloomberg reports the device will sell for $1.85 million.

Intuitive will continue to offer its da Vinci Si and da Vinci Si-e, which is a lower-cost system for less complex surgeries.

The da Vinci Xi surgical robot fixes a mechanical problem found on older models. According to Intuitive, the new overhead instrument arm architecture allows the robot to reach all parts of a patient’s anatomy without repositioning the machine. Other new features include:

An endoscope digital architecture for a more compact design
The endoscope can be attached to any arm for greater flexibility and visualization
Smaller, thinner arms with redesigned joints offer a greater range of motion
Longer instrument shafts provide greater operative reach

Intuitive also says the da Vinci Xi has has broader capabilities than prior generations as it can be used for a variety of minimally-invasive procedures and has been optimized for multi-quadrant surgeries.

“Our goal is to develop technology that enhances surgical performance,” says Gary Guthart, Intuitive President and CEO. “The da Vinci Xi System’s new overhead architecture means that multi-quadrant surgery can be performed without repositioning the system, an innovation long sought by surgeons who perform complex procedures.”

Thinner Robotic Arms Cause Less Friction

The thinner arms on the da Vinci Xi should prevent the robotics arms from bumping into each other and causing friction during surgeries, which has been a problem for Intuitive in the past. In Nov. 2013, Intuitive issued a warning that its da Vinci Si surgical robot may momentarily stall during procedures and endanger patients.

The FDA deemed this a Class II recall, meaning the device could cause “temporary or medically reversible” health problems, with a remote potential for serious complications. The notice stated:

“Reports of friction within certain instrument arms can interrupt smooth instrument motion,” adding, “This can be felt by the surgeon as resistance in the movement of the master. In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance.”

The da Vinci Si wasn’t recalled from the market, and Intuitive urged customers to inform surgeons about the matter and schedule inspections of the devices.

da Vinci Xi Sales Outlook

Shares of Intuitive jumped 15 percent to $502.88 in early trading after news of the da Vinci Xi broke. Before the announcement, Intuitive’s shares had declined 25 percent from February 2013 as the FDA was investigating potential issues with the da Vinci system. The da Vinci system experienced a 23 percent decline in sales to $205 million in the fourth quarter of 2013.

So what do analysts anticipate for the da Vinci Xi?

According to Bloomberg, Vijay Kumar, an analyst at ISI Group LLC, said in a note to clients that the Xi may sell up to 1,000 units. ?The new Xi launch is a positive for ISRG, despite the fact that this was widely expected by investors.?

“The new system came a bit earlier than we expected, and is a very good improvement on the open surgery part of the ledger -particularly for colorectal surgery,” Suntrust Robinson Humphrey analyst Amit Hasan writes in a note obtained by Reuters.

Leerink Swann analyst Richard Newitter isn’t as sold.

“A key question will be whether ‘new technology’ is in fact at the crux of Intuitive Surgical’s slowing procedure growth and system placement trends in recent quarters or whether the headwinds Intuitive Surgical is facing in its growth deceleration are more structural (and long-lasting) in nature,” Newitter writes in a note to Barrons. “[G]iven capital equipment purchase headwinds in the market broadly, right now it is unclear to us how many incremental systems sales the new robot will drive at this early stage, and whether the features of the new robot will in fact help drive higher utilization into new surgery areas that previously were not occurring.”

Intuitive plans to release its first quarter financial results on April 22 at 4:30 p.m. Eastern Time.