The InsidesTM Systemfi has been granted Breakthrough Device Designation by the US FDA as it addresses a high unmet clinical need.
The InsidesTM Systemfi is now commercially available in the United Kingdom, Europe and New Zealand after being CE-marked and registered on the New Zealand MedSafe WAND database. *The InsidesTM Systemfi is not currently approved for sales in the United States. Caution - Investigational Device, Limited by Federal Law to Investigation Use
*The InsidesTM Systemfi is not currently approved for sales in the United States.
Caution - Investigational Device, Limited by Federal Law to Investigational Use
Chyme Reinfusion is recommended by the European Society of Clinical Nutrition and Metabolism (ESPEN) and American Society for Parenteral and Enteral Nutrition (ASPEN) for the nutrition in patients with acute intestinal failure.
The existing literature also favours chyme reinfusion for its ability to restore intestinal continuity, and improve intestinal function, hydration and the nutritional status of the patient. The benefits of chyme reinfusion improves recovery and conditions patients for definitive surgery.
The InsidesTM Systemfi enables patients to recommence oral feeding and wean off the expensive therapy of parenteral nutrition. This reduces their length of stay in hospital and potential complications.
Connects magnetically to The InsidesTM Pump via the outside of the patient's ostomy appliance whenever the patient needs to power the pump and refeed the content of the ostomy appliance back into their distal intestine.
*The InsidesTM Systemfi is not currently approved for sales in the United States.
Caution - Investigational Device, Limited by Federal Law to Investigational Use
Sits within the ostomy appliance, and pumps the chyme into the distal intestine via The Insides™ Tube
Inserted into the distal intestine and connected to The Insides™ Pump, serving as a conduit for chyme
Associate Professor
Greg O’Grady
Co-Founder & Chief Scientific Officer
“Chyme refeeding reduces recovery time, while minimising harms attributed to a defunctioned colon.”
The InsidesTM Systemfi has been developed on the back of 30+ years of clinical experience in gut nutrition, along with research and development from one of Australasia’s top Universities.
Professor Ian Bissett
Co-Founder & Chief Medical Officer