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
tomaso@sonivie.com
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content:https://www.prnewswire.co.uk/news-releases/sonivie-announces-advancements-in-its-renal-denervation-program-reduced-1-pilot-study-results-radial-access-first-in-human-results-and-fda-pivotal-ide-approval-of-the-thrive-global-study-302205278.html