FDA probes Intuitive Surgical on complication rates

Intuitive Surgical

The FDA is looking into complication rates for surgeries using Intuitive Surgical‘s (NSDQ:ISRG) da Vinci surgical robot, sending a survey to doctors who use the device.

New of the probe, first reported by Bloomberg, sent ISRG shares down 11.1% to $509.89 apiece on Wall Street yesterday. The stock recovered some of that today, hitting $547.62 in pre-market trading and reaching $552.47 each as of about 11 this morning.

The FDA asked surgeons at "key hospitals" to detail any complications they’ve seen with the da Vinci robot, according to a copy of the survey obtained by the news service. The survey also asked about procedures the device might be good for and those it might not be ideal for and about the training they received on using the device.

The news comes on the heels of a study questioning the cost-effectiveness of hysterectomies using the da Vinci.

An FDA spokeswoman told Bloomberg that the agency is trying to get an accurate read on the increase in incident reports it’s seeing.

"It is difficult to know why the reports have increased," Synim Rivers told the news site.

Analysts on Wall Street downplayed the development, affirming or raising their ratings on Intuitive. Cantor Fitzgerald’s Jeremy Feffer raised his rating from "hold" to "buy" today and raised his price target to $575 per share.

"While we certainly understand investor concern over the words ‘FDA probe,’ we see limited risk of this investigation materializing into significant punitive measures against the company," the Cantor analysts wrote. "The main criticisms of [the da Vinci robot] have not been safety-related, but have rather focused on its higher cost relative to outcomes that are equivalent to laparoscopic. But because da Vinci is typically used in more complex cases, the more appropriate comparison is with open surgeries, against which da Vinci has superior outcomes and much lower complication rates."

Intuitive’s chief medical advisor, Myriam Curet, said the robots are "extremely safe," Bloomberg reported.

"There is a lot of redundancy in the system to make it as safe as possible," Curet said, noting that the rates of death and injury are "extraordinarily small."

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