The FDA has granted 510(k) clearance to Endorail (Endostart), a magnetic balloon system designed to help resolve intestinal looping and improve colonoscopy quality.
The system, which is now commercially available in the United States, consists of a single-use balloon catheter and a reusable handpiece containing a magnet. To resolve intestinal looping, the catheter can be inserted into a colonoscope’s tool channel and then filled with the company’s ferromagnetic fluid, which is composed of biocompatible iron powder. The clinician then guides the magnetic handpiece over the patient’s abdomen, pulling and rotating the colonoscope to resolve the intestinal looping.
Endostart noted that clinical trial data on the Endorail system will be presented at this year’s Digestive Disease Week in May.
—GEN Staff
Based on an Endostart press release.
