Founded in 2014 on the achievements of the Therapeutic Intra-Vascular UltraSound-based technology (TIVUS) developed by Cardiosonic for Renal Artery Denervation, Sonivie further developed the technology for Pulmonary Hypertension.
TIVUS has been performing clinical trials in both PAH and RDN and has been awarded three Breakthrough Device Designation from the US FDA to treat PAH patients and Uncontrolled and Resistant Hypertension patients, and has obtained a Premarket Application for FDA approval for PAH.
SoniVie recently completed the enrollment of a Renal Denervation IDE Pilot trial in US and Israel, and is initiating a global Renal Denervation IDE Pivotal trial.