Metavention, Inc. announces the completion of enrollment in the DeLIVER U.S. Study (NCT04285554), to evaluate the safety of sympathetic denervation of the liver using its new Integrated Radio Frequency (iRF) Denervation System.
The purpose of the DeLIVER U.S. Study is to establish the safety of liver denervation with the iRF System in patients with a clustering of metabolic diseases, including type 2 diabetes and hypertension, collectively termed as metabolic syndrome. The study will collect and evaluate changes in patients' glycemic control, blood pressure, and liver steatosis at multiple timepoints for the duration of one year. The data collected will be fundamental in demonstrating the potential of liver denervation to improve both glucose and blood pressure control in a single procedure. The DeLIVER U.S. Study is the first study of its kind to be completed in the United States.
"The research team at Baylor Scott & White Heart and Vascular Hospital is proud to contribute to this study, including enrolling the final patient. While intravascular denervation is not new, this study represents a novel approach, beyond the renal arteries and allows us to explore denervating the liver to potentially treat type 2 diabetes. Furthermore, the iRF technology, which enables single ablation procedures, has the potential to greatly simplify intravascular denervation capabilities," commented Dr. James Choi, principle investigator at Baylor Scott & White.
Sympathetic nervous system (SNS) overactivity is thought to play a central role in multiple metabolic diseases, including hypertension, type 2 diabetes, and fatty liver disease. The sympathetic nervous system is a signaling pathway between the brain and organs such as the liver and kidneys, in the management of metabolic homeostasis. When the SNS becomes overactive, excessive signaling may impede these organs from properly regulating metabolic functions, such as glucose control and blood pressure.
About Metavention, Inc.
Metavention, Inc. is a privately held medical device company headquartered in Maple Grove, Minnesota, and the developer of the iRF Denervation System. Metavention's mission is to deliver innovative and life-changing technology in the treatment of metabolic disease.
Metavention is currently conducting multiple studies around the world with its iRF Denervation System for indications including, renal, hepatic, and multi-organ denervation. For more information, please visit www.metavention.com.
About the iRF Denervation System
Metavention's iRF Denervation System is a novel technology designed to permanently disrupt the overactive sympathetic nerves that contribute to hypertension, type 2 diabetes, and other metabolic diseases. The iRF denervation procedure is catheter-based, minimally invasive, and intended to be a single treatment option. The radio frequency system allows full denervation in a single cycle.
The iRF Denervation System is an investigational device, limited to use in studies only, and is not currently approved in any geography.
About Hypertension (High Blood Pressure)
High blood pressure is a common condition in which the long-term force of blood against the artery walls is great enough that it may eventually cause serious health problems. Potential complications of uncontrolled hypertension include heart attack, stroke, aneurysm, and heart failure. Hypertension is the leading preventable cause of premature death worldwide. Current treatments include lifestyle modifications and medication.
About Type 2 Diabetes
Type 2 diabetes (T2D) is a chronic, progressive metabolic disease characterized by excessive blood sugar levels (hyperglycemia) that affects more than 400 million people worldwide. Potential complications of type 2 diabetes include increased risk of heart disease, stroke, high blood pressure and narrowing of blood vessels (atherosclerosis), nerve damage, kidney failure, glaucoma, and blindness.
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Source: Metavention
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