PR Newswire
20 Jun 2022, 12 GMT+10
TEL AVIV, Israel, June 20, 2022 /PRNewswire/ -- SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular Ultrasound System (TIVUS) to treat a variety of hypertensive disorders, announced that on May 5th 2022 the U.S. Food and Drug Administration granted IDE approval for its "REDUCED1" Pilot study to treat Resistant Hypertension Patients with Renal Artery Denervation using TIVUS, its innovative Ultra-Sound Ablation System.
Resistant hypertension is defined as blood pressure higher than 140/90 mmHg despite use of three antihypertensive medications of different classes at the best tolerated doses, one of which must be a diuretic. Millions of people world-wide suffer from resistant hypertension which substantially increases the risk of heart attack, stroke and kidney failure.
"We are very pleased that FDA has approved the REDUCED1 (Renal Denervation using Ultrasonic Catheter EmitteD energy) study. Sites initiation has started, and many clinical teams have responded very favourably about participating to the study. There is a significant number of patients that may benefit from our technology and we are genuinely happy for this important step towards the introduction of TIVUS in the US. There is a lack of effective therapeutic solutions for patients suffering from resistant hypertension, and physicians are looking forward to a safe, effective and easy to use device treatment," says Christian Spaulding, CMO, SoniVie Ltd.
"This is a significant US Regulatory milestone for SoniVie, starting the feasibility study using the Ultra-Sound ablation platform in the US for the Renal Denervation indication. This is a major step and priority in the company's history," says Tomaso Zambelli, CEO, SoniVie LTD.
The REDUCED1 study will further expand the Company's clinical experience based on two clinical trials in Renal Denervation performed using the earlier generation of the TIVUS.
Renal Denervation with TIVUS is a minimally invasive procedure that uses high-frequency non-focused Ultra-Sound energy to ablate nerves in the renal artery. This causes a reduction in the nerve activity, which may decrease blood pressure. This procedure is designed for patients who suffer from resistant hypertension.
About SoniVie
SoniVie is a medical device company developing the TIVUS, the only Ultra-Sound Denervation platform with active development programs in three therapeutic areas: pulmonary artery denervation for pulmonary hypertension, renal artery denervation for resistant hypertension, and lung denervation for chronic obstructive pulmonary disease with chronic bronchitis. These diseases affect millions of patients in the United States and Europe.
Contact:
Tomaso Zambelli
+39 348 4011983
tomaso@sonivie.com
info@sonivie.com
SOURCE SONIVIE
Get a daily dose of Malaysia Sun news through our daily email, its complimentary and keeps you fully up to date with world and business news as well.
Publish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to Malaysia Sun.
More InformationISLAMABAD, Pakistan - Given the country's ongoing economic crisis and acute fuel shortage, the Pakistan government is considering purchasing oil ...
ASSAM, India: During this week's heavy rains, which caused the region's worst floods in years, staff at the Cachar Cancer ...
KATHMANDU, Nepal - According to human rights activists, if people choose sex work as a profession voluntarily, the state should ...
KAREN STATE, Myanmar - Over the past three days, an army outpost meters away from Myanmar's border with Thailand has ...
DHAKA, Bangladesh- The Japanese government is lending Bangladesh $ 1.4 billion (Tk11,400 crore) to construct a subway in Dhaka. Both ...
SULAWESI, Indonesia: Using just a rope, an Indonesian man, supported by fellow villagers on the island of Sulawesi, captured a ...
NEW YORK, New York - U.S. stocks rebounded on Friday, a day after major across-the-board sell-offs."Consensus estimates for 2022 and ...
GENEVA, Switzerland: Swiss pharmaceutical group Novartis has said, as part of its previously announced restructuring program, that it could cut ...
SHANGHAI, China: Walt Disney Company reopened Shanghai Disneyland on 30th June, one month after the city lifted a two month ...
SYDNEY, NSW, Australia - Stocks in Asia skidded lower Friday with all the major indices recording solid losses."Capitulation is the ...
ISLAMABAD, Pakistan - Given the country's ongoing economic crisis and acute fuel shortage, the Pakistan government is considering purchasing oil ...
WASHINGTON, D.C.: Amidst the rise of "re-fracs" in the U.S. as part of the efforts to boost domestic oil production, ...