Lumendi 510(k) for Endoscopic Polyp Surgery

FDA has cleared a Lumendi 510(k) for its DiLumen EIP technology with “suture loops” placed in the skirt along the trailing edge of the fore balloon, a modification to improve tissue retraction during therapeutic endoscopy. “This new device feature will help facilitate tissue manipulation for easier dissection and resection of polyps without the need for surgical intervention,” the company says. The device offers working lengths of 103 cm, 130 cm and 168 cm, which helps provide stability and traction in any part of the colon, it says.

With the suture loops to be attached to the DiLumen’s fore balloon assembly, an endoscopic clip can then be simultaneously attached to the suture and the mucosal edge of a polyp during resection, Lumendi says. “Because the DiLumen fore balloon can be moved back and forth, doctors can now provide traction to the tissue, which will enhance their ability to lift and dissect and ultimately resect polyps,” it adds.