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Endostart Receives FDA Clearance for Endorail Product to Optimize Outcomes of Colonoscopy Procedures

Endostarta medical device company specializing in gastrointestinal endoscopy solutions, announced a “major breakthrough” with the FDA 510(k) authorization of its flagship product, Endorail. Endorail is a magnetic balloon solution that optimizes the results of colonoscopy procedures.

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

Now commercially available in the United States, Endorail is said to improve the efficiency and safety of endoscopic procedures, providing a solution to resolve loops and ease competition from extended colonoscopies. Designed to streamline the colonoscopy process, Endorail combines its magnetic balloon solution with user-friendly features, which the company says allow doctors to overcome procedural challenges with “confidence and precision.”

With Endorail, physicians have access to an on-demand tool that optimizes procedure outcomes and reduces healthcare costs associated with prolonged or incomplete procedures.

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

“We are thrilled to receive FDA clearance for Endorail, marking an important milestone in our journey to revolutionize gastrointestinal endoscopy,” said Dr. Alessandro Tozzi, co-founder and CEO of Endostart. “This authorization underscores our commitment to innovation and our commitment to improving patient care. We look forward to introducing Endorail to endoscopy centers across the United States, giving physicians the tools they need to provide exceptional care.”

In 2023, Endostart conducted a multicenter clinical trial to demonstrate the high safety and effectiveness profile of Endorail in performing difficult colonoscopies. The results of the study will be presented at the Digestive Disease Week conference, which will be held in Washington DC, from 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 undergoing prolonged colonoscopies. Future studies will be conducted to identify additional benefits, including cost and time-saving advantages with our device.



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