Here’s what you should know:
1. DiLumen is a nonsterile, single-use, sleeve that fits over an endoscope to allow for increased visualization.
2. The DiLumen received FDA 510(k) clearance in December 2016 and has been commercially available since May 2017.
3. The 100 completed procedures are in addition to those from Lumendi’s first in-human trial of DiLumen, which was completed in October 2017.
4. Lumendi estimates that 30 endoscopists and colorectal surgeons across the country have used DiLumen to date.
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