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FDA Clears Single-Site Wristed Needle Driver for da Vinci Si Surgical System

Intuitive Surgical, Inc. today announced that it has received U.S. Food and Drug Administration (FDA) clearance for the Single-Site Wristed Needle Driver for use in single-incision surgery. This latest addition to the Single-Site suite of instruments has been cleared for use with the da Vinci Si Surgical System for minimally invasive removal of the uterus (hysterectomy), the ovaries and fallopian tubes for benign conditions, as well as removal of the gallbladder.

"As the first 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," said Dave Rosa, Executive Vice President and Chief Scientific Officer at Intuitive Surgical.

Single-Site Instrumentation facilitates virtually scarless surgeries through a single-incision, while providing surgeons the benefits of robotic and computer assistance. These include surgical precision, control, stability, 3D-HD visualization and an ergonomic seated position. Together, the da Vinci System and Single-Site instruments are designed to minimize instrument crowding while maximizing available working space as compared with hand-held, laparoscopic single-incision instrumentation.

"It's truly a remarkable engineering achievement to have a flexible instrument with a wristed tip that provides surgical precision," said Dwight Im, M.D., Mercy Medical Center, Baltimore, who participated in the user testing that led to FDA clearance.

The Single-Site Wristed Needle Driver was developed in part to facilitate suturing after removal of the uterus. It can move the instrument tip up to 45 degrees in all directions for precise needle positioning. This 5 mm instrument also features serrated jaws to facilitate needle handling.

"The debut of the wristed needle driver heralds an advancement in the evolution of the Single-Site platform for da Vinci procedures," said Devin Garza, M.D., of North Austin Medical Center, Austin, Texas, a user-testing participant. "It is likely to change the playing field with regard to the availability of this approach for benign hysterectomy procedures," Garza said.

This clearance means that the Single-Site Wristed Needle Driver is now available for sale in the United States. With the U.S. introduction underway, Intuitive Surgical will seek regulatory approvals to market the Single-Site Wristed Needle Driver for the da Vinci Si System around the world.

"We now have the last piece of the puzzle for Single-Site hysterectomy," said Thomas Payne, M.D., Texas Institute of Robotic Surgery in Austin, who was also a user-testing participant. "This technology is a true tipping point for this procedure," Payne said.

Since the da Vinci System was first cleared for use in gynecology in 2005, the use of minimally invasive surgery in hysterectomy has nearly doubled. da Vinci Surgery is currently the most common minimally invasive surgical approach used by surgeons for removal of the uterus in the United States. With the introduction of the Wristed Needle Driver, surgeons now have a new tool designed to facilitate suturing during a single-incision approach to da Vinci Surgery for benign hysterectomy and removal of the ovaries and fallopian tubes.


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