FDA clears modification to Lumendi's DiLumen EIP: 6 insights

Lumendi received FDA 510(k) clearance for a modification to its DiLumen Endolumenal Interventional Platform.

Here are six things to know:

1. The DiLumen EIP technology is designed to improve endoscopists' ability to dissect and resect polyps without the need for surgical intervention.

2. With working lengths of 103 centimeters, 130 centimeters and 168 centimeters, the DiLumen EIP is intended to provide stability and traction in any part of the colon.

3. The modified platform features 'suture loops' in the skirt along the trailing edge of the fore balloon. This allows for the suture loops to be attached to the DiLumen's fore balloon assembly.

4. An endoscopic clip can also be attached to the suture and the mucosal edge of a polyp during resection. The DiLumen fore balloon can be moved back and forth, which is intended to help physicians provide traction to the tissue.

5. The platform is a non-sterile, single-use, close-fitting sleeve designed to fit securely over a standard endoscope to stabilize it in the large intestine and facilitate use of the endoscope for visualization, diagnosis, tissue manipulation and treatment.

6. More than 40 endoscopists and colorectal surgeons have performed more than 500 procedures using DiLumen EIP technology.

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