Metavention’s RADAR Pivotal IDE Study Approved for the iRF Renal Denervation System

June 21, 2023—Metavention, Inc. announced it has received investigational device exemption (IDE) approval from the FDA to initiate the RADAR Pivotal study. The study is being conducted to determine the safety and efficacy of the company's integrated radio frequency (iRF) renal denervation (RDN) system for the treatment of hypertension.

RADAR Pivotal is a randomized, double-blinded, sham-controlled study that will allow enrollment of 300 patients at 50 centers.

According to Metavention, its iRF denervation system uses an integrated multi-RF electrode balloon with a cooling circuit to provide RDN in a single ablation cycle. By requiring only one ablation per kidney, the iRF system is intended to significantly simplify and standardize the denervation procedure.

The Metavention iRF denervation system is an investigational device, limited to use in studies only, and is not currently approved in any geography, advised the company.

Todd Berg, CEO of Metavention, commented in the company’s press release, “The benefits of RDN for the treatment of uncontrolled hypertension have been meticulously studied for over a decade. The procedure could represent a new frontier in hypertension management for interventionalists. This pivotal study of the iRF denervation system is a tremendous opportunity to bring next-generation capabilities to this emerging field.”