09.18.14
Sunnyvale, Calif.-based Intuitive Surgical has received 510(k) U.S. Food and Drug Administration clearance for the use of the Da Vinci S and Da Vinci Si surgical systems in benign, base of tongue resection procedures. These procedures are performed transorally, or through the mouth opening, by otolaryngologic, or ear nose and throat (ENT) surgeons. These procedures involve removal or resection of non-cancerous or benign tissue at the base of the tongue, near the opening of the throat.
The Da Vinci suite of systems are robotic systems designed to aid surgeons performing various types of procedures. The systems offer high-definition 3-D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.
“I am pleased with this next step in our progress in serving the transoral otolaryngology market,” said Dave Rosa, executive vice president and chief scientific officer at Intuitive Surgical. “The significance of this clearance is ENT physicians can now offer their patients a new minimally invasive option for benign base of tongue resection procedures.”
The two Da Vinci systems were previously cleared for use in transoral otolaryngology procedures restricted to early stage benign or malignant (cancerous) tumors classified as T1 and T2. The Da Vinci Xi system is not currently indicated for use in transoral otolaryngologic surgical procedures.
The Da Vinci suite of systems are robotic systems designed to aid surgeons performing various types of procedures. The systems offer high-definition 3-D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.
“I am pleased with this next step in our progress in serving the transoral otolaryngology market,” said Dave Rosa, executive vice president and chief scientific officer at Intuitive Surgical. “The significance of this clearance is ENT physicians can now offer their patients a new minimally invasive option for benign base of tongue resection procedures.”
The two Da Vinci systems were previously cleared for use in transoral otolaryngology procedures restricted to early stage benign or malignant (cancerous) tumors classified as T1 and T2. The Da Vinci Xi system is not currently indicated for use in transoral otolaryngologic surgical procedures.