SoniVie’s Tivus Renal Denervation System Receives IDE Approval for the REDUCED1 Pilot Study

June 20, 2022—SoniVie Ltd., an Israel-based company developing the Tivus therapeutic intravascular ultrasound system to treat a variety of hypertensive disorders, announced that the FDA granted investigational device exemption (IDE) approval for the REDUCED1 pilot study, which will evaluate the Tivus ultrasound ablation system for renal denervation (RDN) in the treatment of patients with resistant hypertension.

According to the company, the study will expand the company’s clinical experience based on two clinical trials in RDN performed using the earlier generation of Tivus. RDN with Tivus is a minimally invasive procedure that uses high-frequency, nonfocused ultrasound energy to ablate nerves in the renal artery. This causes a reduction in nerve activity, which may decrease blood pressure. This procedure is designed for patients with resistant hypertension, noted the company.

Christian Spaulding, Chief Medical Officer of SoniVie commented in the company press release, “We are very pleased that FDA has approved the REDUCED1 study. Site initiation has started, and many clinical teams have responded very favorably about participating [in] the study. There is a significant number of patients that may benefit from our technology, and we are genuinely happy for this important step toward the introduction of Tivus in the United States. 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.”