The FDA awarded Lumendi's DiLumen C2 510(k) clearance.
Here's what you should know.
1. The DiLumen C2 is a second-generation endoscopic accessory. It helps physicians ensure an endoscope is properly positioned in the large intestine to assist with visualization, diagnosis and endoscopic treatment.
2. The DiLumen C2 is designed similarly to the DiLumen EIP, Lumendi's original device. Two balloons are used to create a therapeutic zone inside the colon during an endolumenal intervention.
3. The DiLumen C2 differs from its predecessor as it incorporates two 6mm diameter tool channels.
4. Lumendi created a flexible grasping tool intended for use with the C2 to manipulate mucosal tissue.
Lumendi CEO Peter Johann, MD, said, "We are continuing our commitment to develop innovative devices that facilitate endolumenal procedures for many gastrointestinal interventions in an effort to reduce costs and improve patient outcomes."