Intuitive Surgical (NSDQ:ISRG) said today that it won FDA clearance for a new robotic "wrist" used with its da Vinci Si robot-assisted surgery device in single-incision hysterectomies, gallbladder removals and other procedures.
Intuitive said its single-site wristed needle driver was designed in part to facilitate suturing after removal of the uterus; it can move the instrument tip up to 45° in all directions, according to a press release. The company boasts its single-site instrumentation as enabling virtually scarless surgeries through a single-incision, while providing surgeons better precision, control, stability, 3D-HD visualization and an ergonomic seated position.
The Sunnyvale, Calif.-based company said it’s also seeking approval in markets outside the U.S.
"As the 1st fully articulating robotic single-port instrument available on the market, this is truly a transformative technology for surgeons and patients seeking a minimally invasive option," chief scientific officer Dave Rosa said in prepared remarks.
In April, the FDA cleared a new robot-assisted platform from Intuitive, the da Vinci Xi. That same month, the watchdog agency issued a warning on the use of laparoscopic power morcellators in hysterectomies and myomectomies, on the risk that the procedure could unintentionally spread undetected uterine cancers. Intuitive said the warning appeared to be having a "muted" effect on da Vinci myomectomies, even though the system doesn’t include a morcellator attachment.
"Within our gynecology segment, negative trends in da Vinci use in U.S. hysterectomy in the 1st quarter moderated in the 2nd," CEO Gary Guthart said during a conference call discussing the company’s 2nd-quarter results. "That said, the macro environment around U.S. hysterectomy appears unchanged and overall performance in hysterectomy is likely better understood by viewing the first half of 2014 as a whole versus a quarterly breakout. Overall, general surgery interest and utilization in the United States is positive."