FDA echoes questions over Intuitive's surgical robot

Intuitive Surgical is facing scrutiny over its da Vinci surgical robot.--Courtesy of Intuitive Surgical

Last week, a large-scale study in the Journal of the American Medical Association concluded that Intuitive Surgical's ($ISRG) robot does little more than up the cost of procedures, and now the FDA has taken an interest, probing surgeons on just how beneficial the devices are.

As Bloomberg reports, the agency is surveying hospitals on complications, outcomes and dangers with Intuitive's da Vinci robot, a $1.5 million device used in about 500,000 procedures last year. The FDA says it's conducting the probe in response to an uptick in adverse event reports, including organ damage and device failure, and the agency wants to figure out if they result from user error or design problems with da Vinci, a spokeswoman told Bloomberg.

In any case, an increase in scrutiny and questioning doesn't do Intuitive any favors. The surgical robot accounts for most of the company's sales, reaching $2.2 billion last year, and those figures could plummet if hospitals lose faith in da Vinci's efficacy or, worse, if the FDA recalls the system, whether by component or en masse.

Also, if the agency deems da Vinci to be less than effective in certain procedures, it could choose to scale back the robot's indications, much as it did with Stryker's ($SYK) Wingspan brain stent back in August.

For its part, Intuitive asserts that da Vinci is safe, and spokeswoman Myriam Curet told Bloomberg the number of adverse event reports is "extraordinarily small" and hasn't grown over time. And while that may be true, it doesn't address the JAMA study's conclusion that using da Vinci tacks $2,200 onto the cost of surgery with little to no added patient benefits.

Surgical robots have become something of a craze in healthcare over the past few years, pitched to patients as safe and futuristic by hospitals pressured to keep up with the Joneses in the industry. But, under the new spendthrift paradigm of healthcare reform, companies like Intuitive could find themselves scrambling to maintain revenue growth if the conventional wisdom on the likes of da Vinci changes.

- read Bloomberg's story

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