Author(s): Sharona Ross MD, Timothy Bourdeau
FlexDex, Inc developed the FlexDex system. As this device is a purely mechanical tool, it is listed as a Class I medical device with the FDA.
The FlexDex system is a minimally invasive surgical tool that provides surgeons with additional degrees of motion compared with traditional laparoscopic instruments. The technological developments within the device include: a “virtual center” which transfers the surgeon’s wrist motion to the tip of the instrument, a “three axis gimbal” connecting to a click-on wrist band, and an ergonomic “infinity handle” which allows for 360 degree rotation. To flex the instrument and articulate the end effector, the surgeon simply bends their wrist. Rotating the infinity handle will spin the tool an equal number of degrees, and the squeezable trigger on the handle opens and closes the end effector, allowing for multi-axis wrist control. The FlexDex system has been called a “handheld robotic platform,” designed to provide the intuitive dexterity of robotic surgery in a more cost-effective manner.
FlexDex has been deemed substantially equivalent to traditional laparoscopic instruments.
- The FlexDex system is intended for use in laparoscopic procedures.
- The FlexDex system should not be used for procedures that are not able to be undertaken laparoscopically or robotically.