The Insides® Company is pleased to announce that The Insides® System, an effective chyme reinfusion treatment for enteroatmospheric fistulas and high output enterostomies, is now cleared for sale and commercially available in the United Kingdom and Europe.
This critical commercial milestone follows our ISO 13485 certification and CE mark approval of our flagship product, The Insides® System, with product labelling currently available in the following European languages: French, German, Dutch, Danish, Swedish, Italian, and Spanish.
CEO Garth Sutherland said “These are important milestones for intestinal failure centres, their patients, and our company. The Insides® System can significantly improve health outcomes in patients with serious gut disease. By restoring patient bowel continuity, the chyme reinfusion platform enables patients to resume oral nutrition, thereby reducing the risk of infection, dehydration, organ damage, and reducing the time to surgical closure. My congratulations and thanks go to all of the team and company’s founders on achieving these key milestones”.
TÜV SÜD certified The Insides® Company’s medical device for intestinal chyme reinfusion to be in conformance with the European Medical Device Directive 93/42/EEC, thereby clearing these products for marketing in the UK and Europe.