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 cell. In May 2019, company presented data from the TROPHY1 (TReatment Of Pulmonary HYpertension 1) trial (NCT02835950 and NCT02516722) at EuroPCR 2019. The trial enrolled 23…
