A Novel Device Alternative to Temporary Diverting Ostomies after Rectal Cancer Surgery

After colon resections for rectal cancer, anastomotic leaks can occur in up to 36% of patients with a mortality of up to 22%. Currently, diverting ostomies are often placed above the anastomosis to protect against leaks and the consequences of leaks, but ostomies are highly morbid and expensive to the healthcare system. Savage medical is developing an intraluminal fecal diversion technology that utilizes a novel anchoring mechanism that is safe, reliable, easily reversible, and eliminates the need for temporary ostomy surgery. We have tested our device in short term studies to demonstrate the function and safety of the technology. There are more than 300,000 ostomies performed each year in the US, and a majority of these can be eliminated with the development of the proposed technology. Eliminating the need for a temporary ostomy would on average save over $25K per patient in direct surgical costs and eliminate $8.5K per patient in annual maintenance costs. The Savage Medical's proprietary technology is now at the stage where long term testing in anatomic animal models is required to complete and validate the design. The proposed project is to fund large animal testing, possible design revision requirements, and validation of this novel device as a precursor to human clinical trials.