SoniVie completes enrollment in trial of ultrasound renal denervation for hypertension

The Tivus renal denervation system. [Image from SoniVie]SoniVie announced today that it treated the last patient in a pilot study of its Tivus technology for renal artery denervation to treat hypertension.

Tel Aviv, Israel-based SoniVie develops Tivus (therapeutic intra-vascular ultrasound) to treat a variety of hypertensive disorders. It’s conducting the REDUCED-1 FDA investigational device exemption study to evaluate the renal denervation technology.

The company says the last patient in the trial received treatment with Tivus on Jan. 8.

REDUCED-1 features two enrollment cohorts conducted under an identical protocol in the U.S. and Israel. It enrolled 25 patients in the U.S. and 15 in Israel. All patients are now in the follow-up phase measuring primary efficacy (change in daytime systolic ambulatory blood pressure) at three months. The study also looks at safety at one month and 12 months follow-up.

Tivus, a minimally invasive procedure uses …

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