Vibrant Submits Innovative Non-Drug Treatment for Chronic Idiopathic Constipation for FDA Clearance | News
NEW YORK, December 17, 2021 / PRNewswire-PRWeb / – Vibrant announced that the Vibrant System for Chronic Idiopathic Constipation met its primary endpoints for safety and efficacy in the pivotal V-270 trial. Based on the positive findings of the study, the CEO Lior Ben Tsour announced that the company has submitted a de novo classification request to obtain marketing authorization for the Vibrant System from the United States Food and Drug Administration (FDA).
The Phase III trial evaluated the safety and efficacy of the Vibrant System in 312 patients at more than 70 clinical centers across United States, including Harvard Medical School, Augusta University, Georgia University of Health Sciences, University of Michigan, and the Houston Methodist Hospital. “The development of the Vibrant System highlights the kind of scientific approach we need today to treat so many diseases,” said the gastroenterologist. Satish rao, MD, Ph.D., professor of medicine at the Georgia Medical College, and a principal investigator (PI) in the phase III study. “Vibrant’s goal is to solve a real problem of chronic constipation, which has made life very difficult for those who suffer from it. We believe that the Vibrant system is a significant step towards achieving this goal. “
The New Non-Drug Vibrating System offers new hope to the millions of Americans suffering from chronic idiopathic constipation without satisfactory relief from laxatives. Current studies show that 62% to 78% of CIC patients taking over-the-counter medications may be unhappy or unhappy with the drug’s effect on their constipation and CIC-specific abdominal symptoms2.
Vibrant’s non-drug system benefits from research exploring the gut-brain axis, the connection between the body’s gastrointestinal tract and the enteric nervous system. Vibrant brings a new approach to the problem. By increasing the circadian rhythm, the body’s natural biological clock, through the gut-brain connection, allows bowel function to return to normal naturally, providing significant relief from constipation.
“Vibrant’s New Treatment Improves Constipation Symptoms For Patients While Providing Healthcare Providers With A New Tool To Help With Patients With Chronic Constipation,” CEO Said Lior Ben Tsour. “We look forward to working with the FDA throughout the review process to make this treatment available to clinicians and patients. “
Vibrant is the pioneer of the Synchronized Activation Method ™, a new technological system based on the science of the gut-brain connection via the enteric nervous system (ENS) pathway.
Vibrant is a proprietary and biocompatible treatment for chronic idiopathic constipation (CIC). Treatment consists of an orally administered drug-free capsule that induces bowel movements. The capsule is directed by a pod, which activates and sends operating instructions to the capsule.
The Vibrating capsule is an experimental device limited to experimental use in United States. It is currently under review by the FDA and is not available for sale.
To learn more about Vibrant, visit http://www.vibrantgastro.com
Ben feldman, Marketing Director, Vibrant Gastro, +972 58.6240336, [email protected]
SOURCE Gastro Vibrant