WAVE IV Evaluates Kona Medical's Surround Sound Renal Denervation System

August 27, 2014—Kona Medical announced the initiation of the WAVE IV clinical trial, which will evaluate the safety and efficacy of the company’s noninvasive Surround Sound hypertension therapy system in people with resistant hypertension. The trial will include a treatment arm for those patients who have failed alternate forms of renal denervation. The randomized, sham-controlled, double-blinded trial will treat 132 patients at sites in Europe, New Zealand, Australia, and South America. Surround Sound uses ultrasound, delivered from outside the body, to treat nerves leading to and from the kidney.

The company advised that 69 patients have been treated with Surround Sound across three clinical trials. Results from the previous WAVE I and WAVE II studies demonstrated a response in approximately 75% of patients at 6 months and an excellent safety profile. Data from the WAVE III study of noninvasive renal denervation will be presented at medical conferences this fall.

Roland Schmieder, MD, serves as principal investigator for WAVE IV. Dr. Schmieder is Professor of Internal Medicine, Nephrology, and Hypertension at University Hospital Erlangen in Germany. Dr. Schmieder commented in Kona Medical’s announcement, “We are pleased to participate in this randomized, sham-controlled trial of Kona Medical’s noninvasive therapy for resistant hypertension. With its novel approach, external ultrasound offers potential benefits over existing catheter-based renal denervation techniques. If proven successful, noninvasive renal denervation could greatly reduce costs of treatment and increase access for the millions of people worldwide whose blood pressure is not adequately controlled today.”