Intuitive Surgical gets CE mark for robot-assisted device

The da Vinci X System (Intuitive Surgical)

Intuitive Surgical has bagged a CE mark for the latest product in its da Vinci series of robot-assisted surgical systems. The regulatory nod clears Intuitive Surgical to start selling a device it sees acting as an entry point for hospitals interested in installing robot-assisted surgery systems.

Da Vinci X follows the blueprint established by other products in the range. The product shares the console and cart surgeons use to see and perform procedures with the higher-end Xi product. But by stripping the product of some of the more advanced features of the Xi line, Intuitive Surgical has brought X in at a lower price. This is integral to the positioning of da Vinci X and the company’s rationale for introducing the product.

“Da Vinci X ... enables a compelling entry point to our advanced technologies. Da Vinci Xi will remain our flagship and we will provide customers with logical upgrade paths for more affordable entry-level systems like Si and X to Xi and Sp,” Intuitive Surgical CEO Gary Guthart said on a conference call with investors last week. “Xi will remain the top of the line. Xi has intraoperative table motion. It has automated help and set up and optimization and multiquadrant functions that X will not have.”

Intuitive Surgical hopes the combination of a lower-cost base model and clear upgrade path to access these more advanced features will enable it to bring on new customers and then upsell to them. The company is offering customers who bought the old system in the first quarter the chance to swap it for the new X model. Intuitive Surgical deferred $23 million of revenue in the first quarter to cover the cost of the trade-in program.

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The next step is to secure clearance to sell the product in the U.S. Guthart declined to provide a timeline for getting FDA clearance when asked last week, saying only that it is possible the device could come to market in the U.S. this year.

As the rollout gathers pace, Intuitive Surgical expects lower price systems to more cost-sensitive customers to account for more and more of its sales. If the trends play out as Intuitive Surgical foresees, robot-assisted surgical devices will break into markets that earlier, high-end iterations of the products were priced out of.