Medical device company TransEnterix has secured expanded CE mark approval for its Senhance surgical system.
The expanded indication has been granted for the Senhance system to treat paediatric patients above 10kg (around 22lbs).
TransEnterix president and CEO Anthony Fernando said: “Given the size of the patients, pediatric surgery seeks to use the smallest instruments and scopes possible to minimize invasiveness, yet it is critical to maintaining 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.”
Senhance is the digital laparoscopic platform that helps to maintain laparoscopic MIS standards
The Senhance surgical system is claimed to be the first and only digital laparoscopic platform that will help maintain laparoscopic MIS standards.
It will also help offer digital benefits such as haptic feedback, robotic precision, eye-sensing camera control, comfortable ergonomics and advanced instrumentation, including 3mm microlaparoscopic instruments, eye-sensing camera control and reusable standard instruments to maintain per-procedure costs similar to traditional laparoscopy.
The CE mark approval allows using the Senhance surgical system for laparoscopic surgery in the abdomen and pelvis, as well as limited uses in the thoracic cavity excluding the heart and greater vessels. The system now can be used for adult and pediatric use in CE marked territories.
TransEnterix is currently focused on the commercialization of the Senhance surgical system, which digitises laparoscopic minimally invasive surgery.
The system enables robotic precision, haptic feedback, surgeon camera control through eye sensing and improved ergonomics while providing responsible economics.
It is currently available for sale in the US, the EU, Japan and select other countries.
In January 2019, TransEnterix secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Senhance ultrasonic system.
The company is engaged in digitising the interface between the surgeon and the patient to improve minimally invasive surgery.-NS Medical Devices