Customer Partners with Enercon to Develop & Manufacture a Direct Visualization System
• What is it?
The Direct Visualization System is an intuitive platform that enables simple, single-operator, direct visualization cholangioscopy for detection and treatment of large stones and strictures throughout the pancreatico-biliary system.
The System is comprised of:
- The Catheter for imaging and illumination, navigation, irrigation and aspiration, and delivery of various devices
- The Digital Controller [developed and manufactured by Enercon Technologies] that processes the video signal for display on an external monitor, provides dual LED illumination to the Catheter along with automatic light control and enables control of the light source through a front panel user interface.
• Why is this product important?
Each year, more than one million people throughout the world undergo endoscopic retrograde cholangiopancreatography (ERCP) for conditions related to the liver, gallbladder, pancreas and bile ducts. The benefits of direct visualization cholangioscopy are well known and documented, but traditional approaches limited adoption due to the need for two operators and continual, costly capital scope repairs.
• Significant features of the camera/controller imaging system?
Camera: The small area of the CMOS camera face (0.726mm x 0.726mm) allows this digital sensor to be mounted in the distal cap of the Catheter. This sensor features a total of 25,600 pixels (160 pixels x 160 pixels), an approximate 4X increase in the number of pixels compared to the previous generation probe. Unlike the previous probe, the digital imager eliminates dead space between pixels which is visualized as a honeycomb pattern by the physician. The field of view is 120˚ allowing the physician to visualize a larger region of interest.
Controller: The Controller provides the power and illumination for the Catheter, receives and decodes the video signal, performs custom image processing to generate standard video signals for display and provides a simple, easy to use interface for control of the light source. The Controller also features automatic light control (ALC).
• Clinical outcomes?
The clinical trial physician commented that the System is a dramatic improvement over the previous system, allowing him to view mucosal structure with impressive morphological detail. He stated that the new system is a game changer and that the cases today altered patient management. Overall, the system exceeded his expectations with regard to image quality, steering, deflection, suction and ease of set-up.
Caution: US Federal law restricts this device to sale by or on the order of a physician.