Metavention announced today that the FDA granted approval to initiate an investigational device exemption (IDE) trial for its renal denervation system.
Minneapolis-based Metavention designed its integrated radiofrequency (iRF) renal denervation system to treat hypertension. The company plans for its randomized, double-blinded, sham-controlled RADAR study to enroll up to 300 patients across 50 centers. This pivotal study evaluates the safety and efficacy of the iRF renal denervation system.
Metavention designed its iRF denervation system to provide an important distinction to renal denervation procedures: it requires only a single ablation cycle per kidney. The company believes this approach could simplify procedures and reduce the overall burden on patients undergoing renal denervation.
The catheter-based, minimally invasive procedure uses an integrated, multi-RF electrode balloon. It also features a cooling circuit to provide renal denervation in the lone ablation cycle. With just one ablation per kidney, Metavention said the iRF system simplifies and standardizes the denervation procedure. The system remains an investigational device and does not hold approval in any geography.
“The benefits of renal denervation for the treatment of uncontrolled hypertension has been meticulously studied for over a decade, the procedure could represent a new frontier in hypertension management for interventionists,” said Todd Berg, Metavention CEO. “This pivotal study of the iRF Denervation System is a tremendous opportunity to bring next-generation capabilities to this emerging field.”
Renal denervation could be a billion-dollar business. But medtech giant Medtronic has faced challenges gathering clinical trial evidence to show that its Symplicity Spyral renal denervation system outperforms hypertension drugs. ReCor Medical — another company active in the space — announced more positive study results in February related to its Paradise ultrasound renal denervation (uRDN) system.