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April 2, 2014

FDA OKs first major da Vinci upgrades in five years

Daily Briefing

    Intuitive Surgical on Tuesday announced that FDA has cleared the first major upgrade of its da Vinci robot in five years, providing a needed boost for the surgery system that has struggled with safety and efficacy concerns in recent years.

    The da Vinci Xi System is the fourth generation of Intuitive's surgical system, which allows surgeons to perform minimally invasive procedures using hand controls at a computer system several feet away from the patient. The latest model features thinner arms that can reach multiple incision sites and reduce the chances of the surgical arms interfering with each other, the company said.

    The new model also includes a fluorescent imaging system—called Firefly—that may improve safety by allowing clearer imaging of organs' blood supply. Additionally, the integration of the robot's power supply in the new model may minimize excess energy at the surgery site and result in less tissue damage.

    Salvatore Brogna, senior vice president for product development at Intuitive, says the new robot will be available immediately and cost between $1.85 million and $2.3 million. The da Vinci Xi is being marketed to surgeons as a solution for more complex surgeries. "Some of the complex surgeries now done by a smaller group of [surgeons] can be done by a larger group of [surgeons] because of the ease of use," he says.

    Brogna notes that the company's current models (the da Vinci Si System and the Vinci Si-e system) will still be available for less complicated procedures.

    A needed boost for the devicemaker

    The announcement follows last year's warning that devices used in Intuitive's da Vinci Si System may momentarily stall during procedures. FDA classified the issue as a Class II recall, meaning that the agency was concerned that the da Vinci robot could cause "temporary or medically reversible" health problems.

    Why Intuitive issued a recall for da Vinci surgical system

    Intuitive says affected arms were inspected and repaired without needing to be removed from the market. Nonetheless, sales of the da Vinci system have plummeted in recent quarters amid concerns about the safety and efficacy of the device.

    Before news of the FDA approval, investor shares of Intuitive Surgical had decreased 9.6% over a year. On Tuesday, share prices increased by 13%, to $493.60 per share.

    ISI Group analyst Vijay Kumar notes that the last major da Vinci upgrade trigger an increase in sales as facilities upgraded their surgical robot systems. "The new Xi launch is a positive for Intuitive, despite the fact that this was widely expected by investors," he says (Armstong/Langreth, Bloomberg, 4/1; Walker, Wall Street Journal, 4/1).
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