Breakthrough designations go to renal denervation devices in latest FDA batch

FDA has granted breakthrough therapy device designation to two renal artery denervation systems in quick succession. ReCor Medical and SoniVie disclosed the FDA actions within one day of each other as the agency continued to award regulatory privileges to device developers in the closing weeks of 2020. 

SoniVie was the first of the device developers to disclose the receipt of a breakthrough designation. FDA granted the status to the Israeli-based SoniVie’s Therapeutic Intra-Vascular Ultrasound (TIVUS) System for use in the treatment of resistant hypertension, defined as the persistence of high blood pressure despite the use of three classes of antihypertensive medication. 

TIVUS uses high-frequency non-focused ultrasound to ablate nerves in the renal artery. In doing so, the device is designed to reduce nerve activity and, by extension, lower blood pressure. Cardiosonic, the original developer of the technology, linked TIVUS to mean reductions in systolic and diastolic office blood pressure at six months of 30.6 and 14.1 mm Hg, respectively, in a small trial.  

Cardiosonic received a CE mark for the device in 2014 and outlined plans to use it in the treatment of resistant hypertension. SoniVie originally licensed the device for use in the treatment of pulmonary arterial hypertension and picked up a breakthrough designation in that indication last year. Now, SoniVie has licensed the remaining intellectual property from Cardiosonic.

If SoniVie brings TIVUS to the U.S. market, it may face competition from ReCor Medical, a subsidiary of Otsuka Medical Devices. The day after SoniVie shared its update, ReCor revealed FDA has awarded breakthrough status to its ultrasound renal denervation system for use in the treatment of patients with persistently high blood pressure. 

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