SoniVie has secured the US Food and Drug Administration (FDA) approval for the IDE study of its Therapeutic Intra-Vascular Ultrasound (TIVUS) System in pulmonary arterial hypertension (PAH) patients.
PAH is a disease that narrows the small blood vessels of the lungs, causing an increased pressure in pulmonary-artery, and leads to worsening of heart function.
The Israeli medical device maker said that the IDE trial is the first randomised, controlled medical device trial for PAH treatment.
TIVUS is a therapeutic catheter designed to treat PAH through insertion into the pulmonary artery during a right heart catheterisation procedure.
The device selectively ablates nerves related o PAH, without harming the walls of blood vessel or nearby tissues, said the company
Columbia University college of physicians and surgeons adjunct professor Lewis Rubin said: “Despite the availability of approved pharmacotherapy for PAH, a condition with a five-year mortality rate greater than 40 percent, there is an urgent need for new therapies that can improve outcomes for patients living with this life-threatening, debilitating disease.
“The TIVUS System has the potential to address PAH at a physiologic level by selectively ablating nerves associated with disease activity, specifically targeting the cause of disease without the systemic exposure and attendant side effects associated with pharmacotherapy.”
SoniVie will conduct the TIVUS System IDE trial in US, Europe, Israel and Australia
SoniVie intends to conduct the international, randomised, sham-controlled clinical trial, in 168 eligible PAH patients, with functional class II/III and taking at least 2 medications, at 25 sites in the US, Europe, Israel and Australia.
In the study, the participants in the treatment group will be subjected to nerve ablation using the TIVUS System during a right heart catheterisation procedure
Participants in the sham group will be subjected to catheterisation without nerve ablation and they will be allowed to undergo TIVUS treatment only after six months.
The difference in six-minute walk distance (6MWD) at six months is the primary endpoint of the study.
In September 2019, TIVUS has received the FDA Breakthrough Device Designation, as it is the first therapeutic product to leverage high-frequency non-focused ultrasound to treat PAH.
