SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular Ultrasound System (TIVUS) to treat a variety of hypertensive disorders, announced that 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 ultra-sound ablation system.
"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 favorably 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," said Christian Spaulding, CMO, SoniVie Ltd.
"This is a significant U.S. 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.
