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Medical Devices / Submissions and Approvals

FDA Hands SoniVie Breakthrough Designation for PAH Treatment

Sept. 10, 2019
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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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