London-based Lumendi received 510(k) clearance from the FDA for its DiLumen, an endoscopic accessory.
Here's what you should know.
1. DiLumen was is a single-use flexible sheath that was designed to allow complete positioning of an endoscope in the large intestine while assisting with visualization, diagnosis and endoscopic treatment.
The device uses two balloons to create a therapeutic zone which allows for manipulation of the colon.
2. The accessory stabilized a colonoscope to allow for incision-free endoluminal therapeutic procedures.
3. The accessory was developed by Lumendi in collaboration with the minimally invasive new technologies program at Weill Cornell Medicine and New York-Presbyterian, both in New York.
4. CEO Peter Johann, MD, said the DiLumen is the "first step in a family of devices to enhance endoscopic treatment."