TEL-AVIV, Israel, June 20, 2022 /PRNewswire/ — SoniVie, an Israeli company developing a new proprietary Therapeutic Intravascular Ultrasound System (TIVUS™) to treat a variety of hypertensive disorders, announced that on May 5, 2022 , the United States Food and Drug Administration (FDA) had approved IDE for its “REDUCED1” pilot study to treat patients with resistant hypertension with renal artery denervation using TIVUS™, its system innovative ultrasound ablation.
Resistant hypertension is defined as blood pressure above 140/90 mmHg despite the use of three antihypertensive drugs of different classes at the best tolerated doses, one of which must be a diuretic. Millions of people around the world suffer from resistant hypertension, which greatly increases the risk of heart attack, stroke and kidney failure.
“We are very pleased that the FDA has approved the REDUCED1 (Renal Denervation using Ultrasonic Catheter EmitteD energy) study. The launch of the sites has begun and many clinical teams have responded very favorably to participating in the study. A significant number of patients could benefit from our technology and we are really pleased with this important step towards the introduction of TIVUS™ in the United States. Effective therapeutic solutions are lacking for patients with resistant hypertension, and physicians are eagerly awaiting a safe, effective and easy-to-use treatment,” said Christian Spaulding, Chief Medical Officer, SoniVie Ltd.
“This is a major US regulatory milestone for SoniVie, which is beginning the feasibility study using the Ultra-Sound ablation platform in the US for the renal denervation indication. This is a major milestone and a priority in the company’s history,” said Tomaso ZambelliCEO of SoniVie LTD.
The REDUCED1 study will further expand the Company’s clinical experience based on two clinical trials of renal denervation performed with the earlier generation of TIVUS™.
Renal denervation with the TIVUS™ is a minimally invasive procedure that uses high-frequency, unfocused ultrasound energy to ablate nerves from the renal artery. This leads to reduced nerve activity, which can lower blood pressure. This procedure is designed for patients who have resistant hypertension.
SoniVie is a medical device company developing the TIVUS™, the only ultrasound denervation platform with active development programs in three therapeutic areas: pulmonary artery denervation for pulmonary hypertension, renal artery denervation for resistant hypertension, and pulmonary denervation for chronic obstructive pulmonary disease with chronic bronchitis. These diseases affect millions of patients in the United States and Europe.