Fractyl Health has announced the commercial availability of its Revita DMR System in Germany, an endoscopic procedural therapy that is based on emerging scientific evidence linking gut dysfunction to metabolic diseases and is designed to remodel the duodenal lining via hydrothermal ablation (ie, duodenal mucosal resurfacing) to edit abnormal intestinal nutrient sensing and signalling mechanisms that are a potential root cause of metabolic diseases. The Revita System has a CE Mark in Europe and has recently established reimbursement in Germany under the NUB reimbursement process.
Initially, Revita will be available to patients at the EVK Hospital in Düsseldorf, where procedures will be conducted by a senior advanced endoscopist, Associate Professor Torsten Beyna, Head Physician of the Medical Clinic. Patients referred for Revita will be managed in close collaboration with the West-German Centre of Diabetes and Health (WDGZ) in Düsseldorf by Professor Stephan Martin, Head Physician and Director. Revita will first be available at select hospitals in Germany with the close collaboration of clinical leaders in both endoscopy and endocrinology, with additional centres to be added in the future.
“We are enthusiastic about the availability of Revita in Düsseldorf for our patients with T2D who are inadequately controlled and at risk of disease progression. Current medical therapies for T2D focus on treating symptoms of the disease and - despite numerous options - nearly 50% of German patients remain inadequately controlled,” said Martin. “Revita addresses a root cause of their disease in the gut for the first time, thereby potentially enabling patients to improve their underlying disease rather than treating symptoms alone. In conjunction with an appropriate modification of diet and lifestyle, Revita may offer a crucial opportunity for a metabolic reset for patients and society.”
"We have been looking forward to the availability of Revita in Germany for quite some time,” said Beyna. “The clinical development of the technology and procedure has demonstrated the key role of the gut in metabolic diseases, and specifically in T2D. Revita is an innovation that can complement the offerings of modern interventional gastroenterology in a manner that has the potential to become an important paradigm shift in how we think about treating the disease.”
In April 2016, Revita received a CE mark in Europe. In the United States, Revita is for investigational use only under US Law and has received Breakthrough Device Designation from the FDA to improve glycaemic control and eliminate insulin needs in T2D patients who are inadequately controlled on long-acting insulin.