The FDA has awarded SoniVie with a Breakthrough Device designation for its Therapeutic Intra-Vascular Ultrasound (TIVUS), a device being developed to treat a number of hypertensive disorders.

The designation was granted for renal artery denervation for the treatment of resistant hypertension, defined as blood pressure that remains above 140/90 mmHg despite the use of three antihypertensive drugs of different classes, one of which must be a diuretic.

The minimally invasive device uses high-frequency, nonfocused ultrasound to ablate nerves in the renal artery, causing a reduction in nerve activity and decreasing blood pressure.