SoniVie, a company based in Israel, won FDA Breakthrough Device Designation for its TIVUS intravascular ultrasound system for patients suffering from pulmonary arterial hypertension (PAH). Currently there are only medications available for PAH and even those don’t do so well at improving mortality rates, so the new designation is potentially a quick path to approval for the new technology.
The TIVUS system is designed to help improve pulmonary vascular resistance by ablating diseased nerves related to PAH, yet sparing vessels walls and other nearby tissues. It works thanks to a special catheter, delivered into the pulmonary artery via a right heart cath procedure, that emits ultrasound at frequencies that destroy nerve cells.
Some details about the clinical research on the TIVUS system, according to SoniVie:
In May 2019, Sonivie presented data from the TROPHY1 (TReatment Of Pulmonary HYpertension 1) trial (NCT02835950 and NCT02516722) 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. The study authors conclude that the TROPHY1 results support the safety of pulmonary denervation using TIVUS in this patient population and suggest that this procedure may improve hemodynamics and exercise tolerance in patients with PAH.
Product page: TIVUS System