Endostart, a gastrointestinal endoscopy-focused medical device company, has received a CE mark for expanded use of its flagship product Endorail.
The latest certification will allow the use of Endorail for enteroscopy.
Endorail is already available in Italy, the UK, and France. It improves endoscopic procedures by enhancing efficiency and safety.
The device secured the US Food and Drug Administration (FDA) 510(k) clearance in March 2024 for gastrointestinal endoscopy including colonoscopy.
With the new CE marking, the device will support diagnosing and treating small bowel conditions, including cancer, bleeding, and chronic inflammatory diseases.
Endostart co-founder and CEO Alessandro Tozzi said: “We are thrilled to obtain the CE mark for small bowel procedures. This milestone has the potential to be a game-changer in managing small bowel diseases.
“It highlights our commitment to innovation and our dedication to developing tools that enhance patient care.”
Endorail utilises a magnetic balloon system that enhances endoscope control in small and large bowel.
It also uses a magnetically anchored balloon to stabilise and guide the endoscope, reducing looping and improving manoeuvrability.
According to Italy-based Endostart, the offering is designed to simplify colonoscopy and boost enteroscopy by supporting both balloon-assisted and push enteroscopy procedures.
In addition, it is said to have a user-friendly design that aids physicians in improving procedural performance. The medical device firm said this leads to more effective outcomes and reduced healthcare costs from prolonged or incomplete procedures.
Italy-based Humanitas Research Hospital digestive endoscopy unit director Alessandro Repici said: “Magnetic balloon-assisted enteroscopy has the potential to transform procedures, not only for small bowel conditions like bleeding or polyps, but also for challenging treatments such as Endoscopic Retrograde Cholangio Pancreatography (ERCP) in altered anatomy.”
Endostart was founded in 2018. The company’s tools addresses diagnostic and therapeutic needs, further expanding the firm’s presence in the gastrointestinal endoscopy sector.
