Endostart receives FDA clearance for Endorail product to optimise colonoscopy procedural outcomes

Endostart, a medical device company specialising in gastrointestinal endoscopy solutions, has announced a ‘major breakthrough’ with the FDA 510(k) clearance of its flagship product, Endorail. Endorail is a magnetic balloon solution that optimises colonoscopy procedural outcomes.

The company says this achievement represents a significant step forward in advancing the field of gastrointestinal endoscopy and improving patient care worldwide.

Now available commercially in the US, Endorail is said to enhance the efficiency and safety of endoscopic procedures, offering a solution to solve looping and facilitate the competition of prolonged colonoscopies. Designed to streamline the colonoscopy process, Endorail combines its magnetic balloon solution with user-friendly features, which the company says empowers physicians to overcome procedural challenges with ‘confidence and precision’.

With Endorail, physicians gain access to an on-demand tool that optimises procedural outcomes as well as reducing the healthcare costs associated with prolonged or incomplete procedures.

Colonoscopy remains a cornerstone procedure for the diagnosis, surveillance, prevention and treatment of various colon diseases, including colorectal cancer and chronic inflammatory bowel diseases.

“We are thrilled to obtain FDA clearance for Endorail, marking a significant milestone in our journey to revolutionise gastrointestinal endoscopy,” said Dr. Alessandro Tozzi, co-founder and CEO of Endostart. “This clearance underscores our commitment to innovation and our dedication to improving patient care. We look forward to introducing Endorail to endoscopic centres across the United States, empowering physicians with the tools they need to deliver exceptional care.”

In 2023, Endostart conducted a multicentre clinical trial to demonstrate the high safety and efficacy profile of Endorail in the completion of difficult colonoscopies. The results of the study will be presented in the Digestive Disease Week Congress, taking place in Washington DC, May 18 to 21, 2024.

Dr. Tozzi added: “Through this study, Endostart and our research partners have established that Endorail is safe and can be used effectively on demand in patients with prolonged colonoscopies. Future studies will be carried out to identify additional benefits, including cost advantages and time-saving with our device.”