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TransEnterix Gains FDA Approval for Surgical Robotic System

By Barry Teater, NCBiotech Writer

Visitors to the TransEnterix Milan Robotic Surgery Center, dedicated in late 2016, practice operating the Senhance Surgical Robot. -- TransEnterix photo

Morrisville-based TransEnterix has received clearance from the U.S. Food and Drug Administration to begin selling its Senhance surgical robotic system.

The announcement sent the medical device company’s stock soaring by more than 80 percent on the New York Stock Exchange.

“The clearance of the Senhance system in the U.S. 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 Pope, president and chief executive officer of TransEnterix.

Pope said Senhance will give surgeons a new option to “enhance the senses, control and comfort” when conducting laparoscopic procedures that have previously been done with basic manual tools. Millions of laparoscopic surgeries are performed each year, and the robotic system can “minimize the invasiveness of surgery for the patient, and maximize value for the hospital,” he said.

With the FDA’s 510(k) clearance, Senhance becomes the first new market entrant into the field of abdominal surgical robotics since 2000, when California-based Intuitive Surgical’s da Vinci Surgical System was approved.

Using the Senhance system, a surgeon can direct small surgical instruments and a camera with precise movements and comfort, TransEnterix said. The system builds on the foundation of laparoscopy and features haptic feedback – a simulation of touch – and eye-sensing camera control for the first time in a robotic surgery platform.

Senhance uses an open architecture, allowing hospitals and surgeons to leverage existing technology within the operating room. The system is engineered to make 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 Steve Eubanks, M.D., a general surgeon and executive director of academic surgery at Florida Hospital in Orlando. “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.”

TransEnterix installed a Senhance system at Florida Hospital’s Institute for Surgical Advancement this summer.

The company also sold Senhance systems to hospitals in France, Germany and Japan earlier this year. In 2016 it opened a European training and research and development center for Senhance in Milan, Italy.

Senhance has CE Mark approval, which allows its sale throughout Europe.

TransEnterix  was founded in 2006 by Synecor, a Chapel Hill business accelerator that spun out of Duke University in 2001.

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