DiLumen C²TM is the Newest FDA Cleared Endoscopic Platform for Endolumenal Procedures

Incorporating two revolutionary instruments that grasp and cut tissue.

We are blazing a new trail of healing and discovery.
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DiLumen C² , like DiLumen, consists of a soft flexible sheath that fits over standard and small diameter endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip. When both balloons are deployed, and inflated the area in between is stabilized.
In addition, DiLumen C² employs two 6mm working channels at the 3 and 9 o’clock position of the endoscope. These working channels accommodate the DiLumen Ig grasper and the DiLumen Is scissor.

The DiLumen C² and instruments are designed to improve stability and manipulation of tissue in the rectum and colon during complex endolumenal procedures such as Endoscopic Submucosal Dissection or ESD.

ESD continues to be a challenging procedure to learn and adapt to a clinicians practice. However, many of the current limitations of ESD can be overcome with the DiLumen C² and instruments.

Inadequate Tissue Retraction and TensionImproved Tissue Retraction and Tension
Current techniques lack proper:
- Visualization of dissection plane
- Gross tissue retraction
- 3D Orientation
- Tension assisted dissection
DiLumen C² and instruments enables grasping and repositioning of tissue:
- Proper retraction of tissue
- Contiguous tissue tension
- Visualization of submucosal tissue plane
- Precise dissection ‘up and away’
This results in:
- Very steep learning curve
- High risk of perforation
- Difficulty in treating bleeding
- Lengthy procedures
- Failed cases
This may result in:
- A shorter learning curve
- Lower perforation risk
- Improved control of bleeding
- Shorter procedures
- More complete resection
Inadequate Tissue DissectionImproved Tissue Dissection
Current techniques and instruments:
- Provide only slow and tedious
dissection to reduce risk of perforation
- Limited ability to manage bleeding
- Constant exchange of instruments
DiLumen C² and instruments enables controlled tissue dissection:
- Faster electrocautery and mechanical cutting
- Improved visualization to manage bleeding
- Fewer instrument exchanges
This results in:
- A slow and tedious procedure lasting hours
This may result in:
- Faster and more precise dissection

DiLumen C² and Instruments Intended Use

The Lumendi DiLumen C² is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment. The DiLumen C² is intended for use with endoscopes having distal tip diameters between 11.5 mm and 14.3 mm in 501k.

The DiLumen Endolumenal Interventional Grasper (“DiLumen Ig”) is a sterile, single use, disposable endoscope accessory intended to be used for grasping and manipulating tissue within the digestive tract under direct endoscopic visualization.

The DiLumen Endolumenal Interventional Scissors (“DiLumen Is”) is a disposable monopolar electrosurgical device intended to be used for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures.

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