FDA Hands SoniVie Breakthrough Designation for PAH Treatment

September 9, 2019

The FDA granted SoniVie breakthrough device designation for its Therapeutic Intravascular Ultrasound (TIVUS) system in patients with pulmonary arterial hypertension.

The system, a dedicated ultrasound catheter, is placed in the pulmonary artery during a heart catheterization procedure to ablate nerves associated with the disease’s effects.

The debilitating, life-threatening rare disease occurs when patients have high blood pressure in the vessels that move blood from the heart to the lungs.

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