Endostart received CE mark approval for the expanded use of its flagship Endorail product. Certaldo, Italy-based Endostart designed Endorail to provide efficiency and safety in endoscopic procedures. The technology utilizes a magnetic balloon system to enhance control of the endoscope in both the small and large bowel. It leverages a magnetically anchored balloon to stabilize and guide the endoscope, reducing looping and improving maneuverability.
Related: Astellas subsidiary Iota wins FDA IDE nod to study implantable bladder device
Endostart says its Endorail solution simplifies the colonoscopy process and improves enteroscopy. It aids in both balloon-assisted and push enteroscopy procedures. Endorail also features a user-friendly design to enhance procedural performance and avoid prolonged or incomplete procedures.
The company said the expanded CE mark makes its procedure more accessible and widely available. That significantly advances gastrointestinal endoscopy and improves patient care, according to a news release.
Endostart already offered Endorail in Italy, the UK and France. The new CE marking expands its enteroscopy solution for diagnosing and treating small bowel conditions. Those can include cancer, bleeding and chronic inflammatory diseases.
“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,” said Dr. Alessandro Tozzi, co-founder and CEO at Endostart.