Senhance robot was cleared by FDA
TransEnterix received FDA 510(k) clearance for the
Senhance Surgical Robotic System. The company acquired the Italian ALF-X technology two years ago, and bet on it after its in-house developed SurgiBot system did not pass FDA.
"The clearance of the Senhance System in the US is a milestone in the
progress of robotics and is expected to deliver improvement in the
efficacy, value and choices offered to patients, surgeons and
hospitals," said Todd M. Pope, President and Chief Executive Officer of
TransEnterix. "Millions of surgical procedures in the US are performed
each year laparoscopically with basic manual tools that limit surgeons'
capability, comfort and control. New choices are needed that enhance the
senses, control and comfort of the surgeon, minimize the invasiveness of
surgery for the patient, and maximize value for the hospital. Senhance
is this new choice."
With this clearance, the Senhance becomes the first new market entrant
into the field of abdominal surgical robotics since 2000. Using the
system, a surgeon directs small surgical instruments and a camera with
precise movements and comfort. The system builds on the foundation of
laparoscopy and features the security of haptic feedback and eye-sensing
camera control for the first time in a robotic surgery platform.
Additionally, the Senhance utilizes an open architecture, which allows
hospitals and surgeons to leverage existing technology investments
within the operating room ecosystem. The system is specifically
engineered to manage operative costs effectively, making robotic surgery
cost-effective on a per-procedure basis through the use of fully
reusable instruments.
"Surgeons are approaching the boundaries of minimally invasive care
performed with handheld manual instruments and cameras, and are seeking
new technologies that will allow us to advance beyond these boundaries,"
said Dr. Steve Eubanks, a general surgeon and Executive Director of
Academic Surgery at Florida Hospital. "The future will be driven by the
appropriate use of robotics and information tools in the operating room.
The Senhance platform grants laparoscopic surgeons robotic precision,
control of our vision, and haptic feedback while minimizing procedural
costs, and is a welcome revolution in our field."
Source: TransEnterix
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