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DiLumen -Model C² -FDA Cleared Endoscopic Platform for Endolumenal Procedures

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Pioneering Endosurgery: we are blazing a new trail of healing and discovery. We are pursuing innovation because patients deserve it.

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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 Tension

Current techniques lack proper:

  • Visualization of dissection plane
  • Gross tissue retraction
  • 3D Orientation
  • Tension assisted dissection

This results in:

  • Very steep learning curve
  • High risk of perforation
  • Difficulty in treating bleeding
  • Lengthy procedures
  • Failed cases

Improved Tissue Retraction and Tension

DiLumen C² and instruments enables grasping and repositioning of tissue:

  • Proper retraction of tissue
  • Continuous tissue tension
  • Visualization of submucosal tissue plane
  • Precise dissection ‘up and away’

This may result in:

  • A shorter learning curve
  • Lower perforation risk
  • Improved control of bleeding
  • Shorter procedures
  • More complete resection

Inadequate 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

This results in:

  • A slow and tedious procedure lasting hours

Improved Tissue Dissection

DiLumen C² and instruments enables controlled tissue dissection:

  • Faster electrocautery and mechanical cutting
  • Improved visualization to manage bleeding
  • Fewer instrument exchanges

This may result in:

  • Faster and more precise dissection

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 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.