SoniVie Commences REDUCED1 Pilot Study of Tivus Renal Denervation System

July 13, 2022—SoniVie, an Israel-based company developing the Tivus therapeutic intravascular ultrasound system to treat a variety of hypertensive disorders, announced that the first patient was treated for hypertension with the Tivus renal artery denervation technology as part of the REDUCED1 pilot study.

The procedure was successfully performed on May 30, 2022, by the study’s principal investigator, Professor Michael Jonas, MD, at the Kaplan Medical Center in Rehovot, Israel.

“We were able to use the Tivus catheter to rapidly and efficiently perform ultrasound-based renal denervation in our patient suffering from uncontrolled hypertension,” commented Prof. Jonas in the company’s press release. “Tivus’s excellent ease of use and its ability to denervate at significant depth of the perivascular space allowed for a short, simple, and straightforward procedure. We will closely follow our patient and look forward to continuing enrollment in this exciting trial.”

SoniVie recently announced that the FDA granted investigational device exemption approval for the REDUCED pilot study of the Tivus system in May 2022.

According to SoniVie, 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 nonfocused ultrasound 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, advised the company.