Lumendi’s DiLumen gets FDA approval for endolumenal therapy
Medical devices maker Lumendi has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its DiLumen for use in endolumenal therapy.
DiLumen is an endoscopic accessory, which has been developed to position an endoscope in the large intestine and improve optical visualization, diagnosis and endoscopic treatment.
The endoscopic accessory will stabilize colonoscope to facilitate incision-free endolumenal therapeutic procedures.
The procedures that use flexible colonoscope and therapeutic devices inserted into the colon to locate and treat diseased tissue while preserving the colon.
Lumendi, along with the Minimally Invasive New Technologies program (MINT), has developed the device at Weill Cornell Medicine and New York-Presbyterian.
DiLumen can be used in the endoscopic treatment of colonic lesions such as polyps, a common condition that affects millions across the globe.
The device features a single-use and soft flexible sheath that is suitable for standard and small-diameter colonoscopes.
It includes two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope.
A stable therapeutic zone (TZ) is created, when both balloons are deployed and inflated.
The TZ is said to facilitate more localized insufflation and manipulation of the colon, helping to offer enhanced access to lesions to enable endoscopists and surgeons to perform precise endolumenal interventions. procedure is
The balloons are deflated and removed along with the colonoscope, after the procedure is completed.
Lumendi CEO Dr Peter Johann said: “DiLumen is the first step in a family of devices to enhance endoscopic treatment, including many promising endolumenal therapeutic procedures, that may ultimately improve patient care.
“Lumendi sees a great potential in endolumenal interventions and is committed to build on this opportunity.”
Image: Lumendi’s DiLumen endoscopic accessory. Photo: courtesy of Business Wire.