SoniVie has won FDA breakthrough device designation for its Therapeutic Intra-Vascular Ultrasound System for patients with pulmonary arterial hypertension.
The Therapeutic Intra-Vascular Ultrasound (TIVUS) System is a dedicated therapeutic ultrasound catheter that enhances the treatment of PAH, the company said early this month. It is inserted into the pulmonary artery during right heart catheterization and is designed to ablate nerves associated with PAH without damaging vessel walls and tissues.