California medical device maker Intuitive Surgical (NSDQ:ISRG) is working its way out of a public relations nightmare, touting results from a pair of independent studies that the company says demonstrate that its da Vinci system is safer than open surgery.
The studies, one a literature analysis and one a multi-center trial, concluded that minimally invasive robot-assisted surgery resulted in fewer complications, less blood loss and a shorter hospital stay, according to Intuitive.
The 1st analysis examined a randomized trial and 12 retrospective studies of patients undergoing radical cystectomy for bladder cancer. The 2nd compared kidney cancer patients who underwent robot-assisted partial kidney removal.
Intuitive Surgical, which has been under fire all year amid patient injury lawsuits and harsh Wall Street analysts’ criticisms, called the new studies an important perspective on the da Vinci device’s safety profile. That didn’t do much for ISRG shares, which were down 1.6% to $369.17 by about 2:05 p.m. today.
"As individuals and agencies seek to understand the impact of robotic-assisted surgery on healthcare outcomes, evidence-based medicine and all peer-reviewed clinical publications become increasingly important in understanding appropriate treatment options," chief medical advisor Dr. Myriam Curet said in prepared remarks. "Robotic-assisted surgery, while prevalent in urology and gynecology, is now being utilized for other important procedures such as cystectomy and partial nephrectomy where patients may benefit from a minimally-invasive option over open surgery."
It’s not the 1st time that minimally invasive da Vinci surgery has been found a safer bet than traditional surgery. Intuitive just last month touted another large independent study showing that minimally invasive prostatectomies, whether with the da Vinci robot or via laparoscopy, are safer than open ones.
Other studies, however, have criticized da Vinci procedures as a costlier type of minimally invasive surgery that confers little benefits over laparoscopic procedures. A study published earlier this year found that robotic surgery complications may be under-reported and therefore less safe than they appear, a conclusion Intuitive called "misleading." Studies published last year raised similar concerns regarding robotic surgery prostatectomies and robotic surgeries to treat endometrial cancer.
Intuitive Surgical has claimed in the past that many of the critical studies are misleading because they compare robotic surgery with laparoscopy rather than open surgery.
"When evaluating minimally invasive surgery techniques, particularly robotic-assisted surgery, which is now the standard of care in the United States for prostatectomies, it is important to use the surgery it is replacing as a comparator," Curet said in a company release issued last month. "The introduction of laparoscopic urologic surgery and subsequent development of robotic techniques have dramatically increased the use of minimally invasive radical prostate surgery. This examination of the most robust, independent surgical database clearly demonstrates that a minimally invasive radical prostatectomy can be safely performed with low complication rates, particularly when compared to alternative procedures."
Intuitive Surgical has been a roller coaster in recent months, facing harsh criticism from analysts and media while facing a raft of patient injury lawsuits accusing the company of pushing surgeons on the company’s flagship da Vinci robot-assisted surgical system before they were properly trained.
The company still has some friends on Wall Street, with analysts at William Blair this month defending the company as a solid long-term investment, but others have been less kind.
Intuitive Surgical’s share price lost 25.3% this year as the company struggled with a series of studies finding robotic surgery equally safe and effective but more expensive than laparoscopy. Investors, who sent ISRG shares to an all-time high of $585.82 apiece in April 2012, have carved some 36.6% from the stock since then.
The device maker has also been publicly battling analysts at Citron Group, which has this year published a series of harsh criticisms of Intuitive’s track record at the FDA. Citron in January 2013 published all of the FDA’s da Vinci adverse event filings, comprising 12 years’ worth of reporting. Earlier this month Citron released another report, accusing Intuitive Surgical of ignoring a surge of new incidents that have cropped up in the FDA’s system.