Breakthrough tag for ultrasound system for PAHNovember 15, 2019
SoniVie’s therapeutic intra-vascular ultrasound (TIVUS) system for patients with pulmonary arterial hypertension (PAH) has been granted breakthrough device designation by USFDA.
TIVUS is a dedicated therapeutic ultrasound catheter to enhance the treatment of PAH and is inserted into the pulmonary artery during a right heart catheterization procedure.
It is designed to ablate nerves associated with disease activity without damaging the vessel walls or the adjacent tissues to improve the quality of life and clinical outcomes.
In May 2019, Sonivie presented data from the TROPHY (TReatment Of Pulmonary HYpertension) trial at EuroPCR 2019.
The trial enrolled 23 Functional Class III PAH patients who were on an established regimen of dual-oral medical therapy. The study found no serious adverse events related to the device or procedure and demonstrated improvements in pulmonary vascular resistance, mean pulmonary artery pressure, six-minute walk distance, daily activity, and European Society of Cardiology (ESC) low-risk indicators compared with baseline assessments.