PR Newswire
20 Jun 2022, 07:30 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
[email protected]
[email protected]
SOURCE SONIVIE
Get a daily dose of Sydney 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 Sydney Sun.
More InformationOTTAWA, Canada: With Canada Post struggling to maintain operations amid labour unrest, rivals like FedEx and UPS are stepping in to...
NEW YORK, New York - U.S. and global markets showed a mixed performance in Tuesday's trading session, with some indices edging higher...
PARIS, France: French military and intelligence officials have accused China of orchestrating a covert campaign to damage the reputation...
NEW DELHI, India: Birkenstock is stepping up its efforts to protect its iconic sandals in India, as local legal representatives conducted...
HONG KONG: China has fired back at the European Union in an escalating trade dispute by imposing new restrictions on medical device...
NEW YORK, New York - Monday's trading session saw mixed performances across U.S. and global markets, with several major indices posting...
DHARAMSHALA, India: The Dalai Lama turned 90 on July 6, celebrated by thousands of followers in the Himalayan town of Dharamshala,...
ZAGREB, Croatia: A massive concert by popular Croatian singer Marko Perković, known by his stage name Thompson, has drawn widespread...
WASHINGTON, D.C.: Elon Musk's entry into the political arena is drawing pushback from top U.S. officials and investors, as his decision...
CULVER CITY, California: TikTok is preparing to roll out a separate version of its app for U.S. users, as efforts to secure a sale...
WASHINGTON, D.C.: President Donald Trump claimed he was unaware that the term shylock is regarded as antisemitic when he used it in...
PARIS, France: A strike by French air traffic controllers demanding improved working conditions caused significant disruptions during...