SoniVie, which has developed a novel Therapeutic Intra-Vascular Ultrasound System (TIVUS) to treat a variety of hypertensive disorders, presented at the EuroPCR 2024 conference (20–23 May, Paris, France) the results of its renal denervation (RDN) REDUCED-1 pilot study, along with a case presentation of the first-in-human treatment with the TIVUS radial access catheter.
James Zidar (University of North Carolina, Chapel Hill, USA) presented the three-month primary efficacy data from the REDUCED-1 pilot study (N=40 patients, 25 in USA and 15 in Israel): an average -12mmHg reduction in daytime ambulatory systolic blood pressure (ASBP) comparing baseline to three-month was obtained, with 78.4% of patients being responders (≥5mm reduction in daytime ASBP). The responder ASBP three-month average reduction was -16.2mmHg. No device related adverse events were reported in the one-month primary safety endpoint analysis, and efficacy data are sustained at six-month follow-up.
“This is the first no-touch RDN device that is not required to be in contact with the renal artery vessel wall, which is unique as the other RDN technologies to date require contact,” commented the EuroPCR panel of discussants and RDN experts.
Michael Jonas (Kaplan Medical Center heart institute, Rehovot, Israel) also introduced the 4Fr Rapid Exchange Radial Access TIVUS catheter as the newest evolution of RDN technologies and presented the first-in-human clinical case performed.
More recently, on 17 July 2024, the US Food and Drug Administration (FDA) approved the THRIVE study, an international, multicentre, randomised, double blind, sham-controlled study, designed to demonstrate the adjunctive effectiveness and safety of the TIVUS system in hypertensive subjects while subjects are maintained off-antihypertensive medications for a four-week wash-out period before RDN/sham procedure and two months after procedure. At two months after procedure, subjects with uncontrolled hypertension will be put back on antihypertensive medication, according to a medication escalation protocol. Unblinding will be performed at six months. Uncontrolled sham subjects will be able to cross over to TIVUS at six months. The THRIVE study is led by a global steering committee comprised of Ajay Kirtane (Columbia University Medical Center, New York, USA), Michel Azizi (George Pompidou Hospital, Paris, France) and Felix Mahfoud (University of Basel, Basel, Switzerland).
Commenting on the approval of the study, Tomaso Zambelli, chief executive officer (CEO) of SoniVie, said: “The SoniVie clinical operations teams throughout the USA, Europe and Israel are now supporting sites, physicians and patients participating in the global pivotal THRIVE study, anticipating enrolment of the first patient in the fourth quarter of 2024.”
SoniVie stated in a recent press release that RDN with TIVUS is a minimally invasive procedure that uses a high-frequency non-focused ultrasound energy catheter which does not anchor to the vessel wall during treatment to ablate nerves in the surrounding tissue located along the renal arteries, thereby reducing sympathetic activity which lowers blood pressure.
