Posted by Michael Wonder on 10 Dec 2020
SoniVie receives FDA breakthrough device designation for the TIVUS system for renal artery denervation
9 December 2020 - SoniVie acquires new intellectual property and other assets from Cardiosonic Moving TIVUS into new therapeutic areas beyond pulmonary hypertension.
SoniVie today announced that it has been granted breakthrough device designation from the U.S. FDA for the TIVUS System for renal artery denervation for the treatment of resistant hypertension, which is defined as blood pressure that remains above 140/90 mmHg despite use of three anti-hypertensive medications of different classes at the best tolerated doses, one of which must be a diuretic.
