Medical device company TransEnterix has received CE Mark approval for an expanded indication of the Senhance Surgical System to treat paediatric patients weighing above 10kg.
The system is intended for use in laparoscopic surgery in the abdomen and pelvis, with limited uses in the thoracic cavity, excluding heart and greater vessels.
TransEnterix president and CEO Anthany Fernando said: “Given the size of the patients, pediatric surgery seeks to use the smallest instruments and scopes possible to minimise invasiveness, yet it is critical to maintain a high degree of precision.
“The Senhance System is designed to maximize control of instruments as small as 3 mm and be compatible with small scopes while also retaining the sense of touch through haptic feedback. This makes our technology uniquely positioned to meet the requirements of pediatric surgeons, and we look forward to working closely with leading European hospitals to serve the needs of their paediatric patients.”
It is the first and only digital laparoscopic platform at this time to maintain laparoscopic MIS standards.
The digital benefits provided by the system include robotic precision, eye-sensing camera control, haptic feedback, advanced instrumentation including 3mm microlaparoscopic instruments, comfortable ergonomics, eye-sensing camera control and reusable standard instruments.
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Netherlands Maastricht University Medical Center pediatric surgery department chairman Dr Wim van Gemert said: “The ability to use 3 mm microlaparoscopic instruments on a robotic platform is very exciting and is a large step forward in treating pediatric patients.
“Especially in younger patients, smaller ports and instruments are critically important in achieving the best outcomes given the body size constraints in these patients.”
TransEnterix claims that the Senhance Surgical system keeps time and cost-per-procedures comparable to manual laparoscopy.