Intuitive's surgical robot hit with another unfavorable study result

Intuitive Surgical's da Vinci robot system--Courtesy of Intuitive Surgical

Intuitive Surgical ($ISRG) had to defend its robotic surgery platform again, this time from a study which reports that insurance claims data shows that bladder cancer patients had a similar complication rate and length of hospital stay regardless of whether their bladder was removed robotically or in a more invasive open procedure.

The study was performed on 118 patients recruited at Memorial Sloan Kettering Cancer Center between 2010 and 2013 who were randomly assigned to either open or robotic surgery.

Intuitive Surgical told The Wall Street Journal that the results are "grossly misleading" because the complications typically occur during the bladder reconstruction phase of the surgery, which is done openly regardless of how the bladder is removed. The Journal article said that the robotic bladder removal costs $16,250 on average, about 10% more than open surgery.

Indeed, cost concerns are one of many issues plaguing the product, especially in an era of cost cutting at hospitals. But worries about safety are the bigger issue due to a slew of unfavorable studies. For instance, last year, Johns Hopkins researchers earlier this month concluded separately that robotic surgery-related complications are grossly underreported, adding to the body of academic evidence that questions robotic surgery's value and overall safety.

Meanwhile, the FDA and others have questioned surgeons' level of training on the device. To top it off, Intuitive issued a recall of more than 1,300 systems in November 2013.

The company announced July 22 that revenues fell 11.5% and profits were down 35% year-over-year in Q2. But Wall Street expected worse results and the stock rose more than 10% following the earnings call, Mass Device says. On the bright side global procedure volume rose by 8%, according to CEO Gary Guthart.

Intuitive shipped 96 systems during the quarter, and more than half were of the upgraded da Vinci Xi system, which was cleared by FDA earlier this year.

- read the study summary in the New England Journal of Medicine
- read the Wall Street Journal article
- read the Mass Device article on Intuitive's earnings

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