Metavention has received approval from the US Food and Drug Administration (FDA) for initiating an investigational device exemption clinical study of the Integrated Radio Frequency (iRF) Renal Denervation System to treat hypertension.
The sham-controlled, double-blinded RADAR Pivotal study intends to enrol up to 300 patients from 50 participating centres.
The iRF Denervation System is a minimally invasive, catheter-based renal denervation procedure that uses an integrated multi-RF electrode balloon with a cooling circuit.
It provides renal denervation in a single ablation cycle and simplifies the denervation procedure and reduces the overall burden on patients.
The renal denervation of the kidneys (RDN) procedure inhibits sympathetic nerve overactivity, which contributes to high blood pressure.
Metavention CEO Todd Berg said: “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 interventionalists.
“This pivotal study of the iRF Denervation System is a tremendous opportunity to bring next-generation capabilities to this emerging field.”
Uncontrolled hypertension leads to potential complications including heart failure, aneurysm, heart attack, as well as stroke.
It is said to be the leading preventable cause of premature death globally and has been treated with medication and modifications to the lifestyle historically.
