Intuitive Surgical Receives FDA Approval For da Vinci Sp Surgical System

By Jof Enriquez,
Follow me on Twitter @jofenriq

The FDA recently granted 510(k) initial clearance to Intuitive Surgical’s da Vinci Sp Surgical System.  The approval is specific to single-port urological surgical procedures for adults.

According to Intuitive’s press release, the system consists of a single 25 mm cannula equipped with three fully articulating EndoWrist Sp Instruments and a 3D HD camera. The instruments include flexible endoscopes, forceps, scissors, retractors dissectors, and electrocautery components that allow the surgeon to manipulate, grasp, cut, and dissect tissue. It is also capable of “approximation, ligation, electrocautery, and suturing through a single incision laparoscopic approach.”

Intuitive claims that the system gives the surgeon more precise control during laparoscopic procedures because its EndoWrist Sp Instruments are fully wristed and offer seven degrees of freedom — two more than da Vinci Single-Site Instruments.

"Our development of this single-port technology represents our foundational commitment to advancing tools for minimally invasive surgery," Gary Guthart, Intuitive Surgical's president and CEO, said in the press release.

Intuitive said that the da Vinci Sp Surgical System (SP999) is compatible with its da Vinci Xi Surgical System, which is aimed for release during the second half of 2015 pending regulatory clearance.

The da Vinci Surgical System allows surgeons to sit at a console while performing surgery. Surgeons look at a magnified 3D HD display of the surgical field while manipulating robotic arms and instruments. Intuitive claims that the system reduces fatigue for the surgeon while reducing torque and the risk of trauma to the body.

However, a spate of lawsuits and product recalls has brought the surgical system’s safety record into question. “Since 2008 the FDA has issued five pages of recalls against the company,” according to The Street.

Intuitive Surgical’s first quarter earnings plummeted 77 percent after a drop in sales of its da Vinci surgical systems, according to the Wall Street Journal. The company also downgraded the projected number of procedures using its system from between 9 and12 percent to between 2 and 8 percent in 2014, according to a separate report by the Journal.

Image credit: ©2014 Intuitive Surgical, Inc.