The Senhance® Surgical System is the first and only digital laparoscopy platform

Indications for Use: Senhance® Surgical System

US Indication:

The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use. The device is restricted to sale by or on the order of a physician.

 

EU Indication:

The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery, suturing, mobilization, retraction, and sealing of vessels up to and including 5 mm in diameter in laparoscopic and thoracoscopic surgery. The system is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use. Use of the device is limited to patients with a weight equal to or above 10 kg and a BMI of up to 40, who are suitable to be subjected to a conventional endoscopic technique.

 

TransEnterix Italia S.R.L. is the legal manufacturer for CE purposes.

 

Eye trackers supplied by Tobii.

 

RADIA articulating instrumentation is only currently available in CE Markets. Four manipulator arm configurations are only available in CE Markets and Japan.

 

Senhance was developed under a license of the European Commission Joint Research Centre.

 

Japan Indication:

The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery, suturing, mobilization, and retraction in laparoscopic surgery. The system is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.

 

Four manipulator arm configurations are only available in CE Markets and Japan.

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