Intuitive Surgical (NSDQ:ISRG) is ready to take its newest surgical robot overseas after landing European market approval for the next-generation da Vinci Xi system.
The new device is a significant departure from the original da Vinci system. The instrument arms on the Xi model stem from a single overhead arm that can swivel and shift along an overhead track, allowing the instruments to move across a patient during surgery without shifting the entire system.
Intuitive’s Xi won FDA clearance in April this year, winning high praise from Wall Street but some sharp jabs from doctors online.
In a blunt editorial following new of the FDA win, Pennsylvania urologist Dr. Benjamin Davies chided Intuitive for moves that he said alienated doctors and hospitals. The self-proclaimed "King of the Urology twitter world" also took to social media, calling Intuitive sales reps "useless," and saying that the company "has blown the rollout of the new bots."
Some objectors took offense in particular to the new device’s incompatibility with the old system. The Xi instruments aren’t plug-and-play compatible with the older Si model.
"The new da Vinci Xi System represents a broadening of the da Vinci platform portfolio, not a replacement for the da Vinci Si System," a spokesperson told MassDevice.com at the time. "Our goal is to align our da Vinci System technologies with case complexity and unique clinical requirements."
The company is also looking to bring Xi to new markets and more procedures. Intuitive is also pursuing regulatory approvals and clearances for new components of the system, such as vessel sealing and fluorescence imaging, according to a press release.
Wall Street didn’t budge much on news of today’s CE Mark win, with ISRG shares up just 0.7% to close at $405.08 by the end of the day today.
