SoniVie announces RDN pilot results, radial access FIH and FDA pivotal IDE approval, initiating the global THRIVE study in US, Europe and Israel
TEL AVIV, Israel, July 24, 2024 /PRNewswire/ -- SoniVie, which has developed a novel proprietary Therapeutic Intra-Vascular Ultrasound System (TIVUS™) to treat a variety of hypertensive disorders, presented on May 15th, 2024 at the EuroPCR conference (Paris, France) the results of its renal denervation REDUCED-1 pilot study, along with a case presentation of the first-in-human treatment with the TIVUS™ Radial Access Catheter.
Dr. James Zidar (University of North Carolina, NC) presented the 3-month primary efficacy data from the REDUCED-1 Pilot study (N=40 patients, 25 in US and 15 in Israel): an average -12.0 mmHg reduction in daytime ambulatory systolic blood pressure (ASBP) comparing baseline to 3-month was obtained, with 78.4% of patients being responders (≥5mm reduction in daytime ASBP). The responder ASBP 3-month average reduction was -16.2mmHg. No device related adverse events were reported in the 1-month primary safety endpoint analysis, and efficacy data are sustained at 6-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 renal denervation experts.
Professor Michael Jonas (Kaplan, Israel) 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 July 17th, 2024, the FDA approved the THRIVE study, an international, multicentre, randomized, 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 4-week wash-out period before RDN/Sham procedure and 2 months after procedure. At 2 months after procedure, subjects with uncontrolled hypertension are put back on antihypertensive medication according to a medication escalation protocol. Unblinding will be performed at 6 months. Uncontrolled sham subjects can crossover to TIVUS™ at 6-months. The THRIVE Study is led by a Global Steering Committee comprised of Dr. Ajay Kirtane (Columbia University Medical Center, New York City, NY), Dr. Michel Azizi (George Pompidou Hospital, Paris, France) and Dr. Felix Mahfoud (University of Basel, Basel, Switzerland).
"The SoniVie clinical operations teams throughout US, Europe and Israel are now supporting sites, physicians and patients participating in the global pivotal THRIVE Study, anticipating enrollment of the first patient in the fourth quarter of 2024", says Tomaso Zambelli, Chief Executive Officer, SoniVie.
Renal Denervation 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.
About SoniVie
SoniVie is a medical device company developing the TIVUS™ System, the only platform denervation technology with active development programs in three therapeutic areas: renal artery denervation for resistant hypertension, pulmonary artery denervation for pulmonary hypertension, and total lung denervation for chronic obstructive pulmonary disease with chronic bronchitis. These diseases affect millions of patients around the world.
The company's offices are located in Rehovot, Israel and in Minneapolis, MN, USA
Contact:
Tomaso Zambelli
CEO, Sonivie
[email protected]
SOURCE SoniVie
