The U.S. Food and Drug Administration (FDA) has granted SoniVie permission to begin a pivotal clinical trial of its Therapeutic Intra-Vascular Ultrasound (TIVUS) System in people with pulmonary arterial hypertension (PAH). This “study will provide important information on the safety and efficacy of the TIVUS System in…
Pulmonary artery denervation was found to be safe and to improve the health of people with pulmonary arterial hypertension (PAH), according to results of an early clinical trial. The study, “Intravascular Ultrasound Pulmonary Artery Denervation to Treat Pulmonary Arterial Hypertension (TROPHY1),” was published in the journal …
The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough device to SoniVie’s Therapeutic Intra-Vascular Ultrasound (TIVUS) System for the treatment of people with pulmonary arterial hypertension (PAH). Similar to breakthrough therapy, the designation of breakthrough device is given to medical equipment…
New data support the safety and effectiveness of TIVUS (therapeutic intra-vascular ultrasound) for patients with pulmonary arterial hypertension (PAH) on a stable treatment regimen. The data were recently presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR), in Paris. In PAH, small arteries inside…
SoniVie recently announced that it has completed the first two procedures in an initial clinical trial evaluating TIVUS system (Therapeutic Intra-Vascular Ultrasound) for the treatment of pulmonary arterial hypertension (PAH). TIVUS is a therapeutic catheter inserted into the pulmonary artery to selectively damage nerves associated with PAH disease activity, without touching vessel walls…
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