FDA Clears New da Vinci Surgical Robot

Megan Brooks

Disclosures

April 02, 2014

The US Food and Drug Administration (FDA) has granted marketing clearance to an upgraded model of the da Vinci surgical robot, Intuitive Surgical announced April 1.

The new da Vinci Xi System has "broader capabilities than prior generations of the da Vinci System. It can be used across a wide spectrum of minimally invasive surgical procedures and has been optimized for complex, multi-quadrant surgeries," the company said in a statement.

The new system was designed "with the goal of further advancing the technology used in minimally invasive surgery for complex diseases and conditions in gynecology, urology, thoracic, cardiac, and general surgery."

Compared to prior systems, key features of the new da Vinci Xi System include a new overhead instrument arm architecture designed to facilitate anatomical access from virtually any position, the company said.

"The da Vinci Xi System's new overhead architecture means that multi-quadrant surgery can be performed without repositioning the system, an innovation long sought by surgeons who perform complex procedures," Gary Guthart, president and chief executive officer of Intuitive Surgical, explained in a statement.

Other new features highlighted by the company include

  • a new endoscope digital architecture that creates a simpler, more compact design with improved visual definition and clarity;

  • an ability to attach the endoscope to any arm, providing flexibility for visualizing the surgical site;

  • smaller and thinner arms with newly designed joints that offer a greater range of motion than ever before; and

  • longer instrument shafts designed to give surgeons greater operative reach.

The da Vinci surgical robot was first approved in the United States in 2000. Since then, questions have swirled around the safety and effectiveness of the new technology.

In January 2013, the FDA reported a spike in adverse event reports, including some involving injuries and death, filed with the FDA's Manufacturer and User Facility Device Experience database from 2011 to 2012. The number of da Vinci procedures during that period increased 26%.

Mishaps on file include accidental electrical burns, severed nerves and blood vessels, and punctured bladders.

The company is currently defending itself in numerous product liability lawsuits. In May of last year, it won a well-publicized case in Washington State. A jury there found that Intuitive Surgical was not liable for the death of a man who underwent da Vinci–style prostate surgery.

Intuitive Surgical says introduction of the new and improved da Vinci system is underway in the United States and that the company plans to seek regulatory clearance to market the system in other countries.

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