Med Device Monday: Lumendi

Endoscopies are often used to scan the intestines and gastrointestinal tract in order to view, assess, biopsy, and help diagnose a variety of diseases. While these procedures don't necessarily require surgery, their inherent limitations do often mean surgery is required to execute the procedure.

DiLumen, a device cleared by FDA at the end of 2016, is an endoscopic accessory that aims to keep these procedures minimally invasive. In the company's own words, "As a new, innovative accessory to an endoscope, DiLumen may facilitate endolumenal therapeutic procedures that otherwise require laparoscopic or open surgery of the colon. When used as instructed, DiLumen ensures the complete positioning of an endoscope in the large intestine and assists with optical visualization, diagnosis, and endoscopic treatment. An endoscopic approach to treatment in the colon may preserve anatomy, eliminate complications associated with colectomy and reduce costs".

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Lumendi stabilizes the scope in the GI tract, thus allowing the physician more control and more options for performing procedures via this route rather than having to go for a full surgery. Business Wire explains, "DiLumen consists of a single-use, soft flexible sheath that fits over standard and small-diameter colonoscopes. The device employs two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope. When both balloons are deployed, and inflated, a stable Therapeutic Zone (TZ) is created. This TZ facilitates more localized insufflation and manipulation of the colon and provides improved access to lesions to enable endoscopists and surgeons to perform precise endolumenal interventions. Once the procedure is complete, the balloons are deflated and removed along with the colonoscope."

Lumendi explains the motivations and benefits: "DiLumen was designed to address the difficulties of these endoscopic procedures. DiLumen facilitates endolumenal therapeutic procedures by:

Stabilizing the tip of the endoscope in relation to the intestinal wall. 

Creating a therapeutic zone inside the intestine that provides improved visualization.

Manipulating the colon wall to enhance access for treatment.

DiLumen has the potential to improve patient outcomes and satisfaction through reduced complications and shorter hospital stays. These improvements may also lead to greatly reduced costs to the healthcare system."

If you've read my posts before, you won't be surprised to hear what excites me about this device! Improving outcomes and providing options for patients, making procedures safer and more effective, and potentially reducing costs and risk of procedures are all wins.


Further reading:

510(k) Pre-market Notification for DiLumen

Classification summary for DiLumen