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| Surgeons reported positive results but inconsistent training with Intuitive Surgical's da Vinci system.--Courtesy of Intuitive Surgical |
The FDA spooked investors when it launched a probe into the safety and effectiveness of Intuitive Surgical's ($ISRG) robotic da Vinci system, but the agency's results point to a muddled conclusion: Surgeons said the devices have a strong benefit but point out that inconsistent training can put patients at risk.
In a survey of 11 surgeons with between 70 and 600 da Vinci-assisted procedures under their belts, the FDA reported that physicians credited the system with fewer complications and shorter recovery times than with open surgery. However, a complex user interface made learning how to use the device difficult, the surgeons said, leading to complications like collision between the robot arms and imprecise incisions.
Complicating matters, each surgeon had a different training experience, the FDA reports, including Intuitive-sponsored events, online courses and practice sessions on animal models. In the survey, the surgeons recommended standardizing da Vinci training, mandating how many simulation hours one must go through before conducting a procedure.
Over the past year, adverse event reports tied to da Vinci have more than doubled, fueling concerns that Intuitive, in its heavy sales push, has failed to adequately train surgeons. The FDA isn't drawing any conclusions from its informal survey, but the surgeons' largely positive comments on da Vinci's efficacy could quell some of the investor worry about the system's long-term market performance.
Still, it has been a long year for Intuitive, starting with concerns about da Vinci's safety profile and followed by physician scorn, declining sales, mounting lawsuits and an FDA warning letter, with each step met by a decline in the company's share price.
- read the survey (PDF)