Randomised, sham-controlled clinical trial of non-invasive, ultrasound therapy for resistant hypertension begins


Kona Medical has announced the initiation of the WAVE IV, randomised, sham-controlled, double-blinded, clinical trial of its Surround Sound Hypertension Therapy System. The 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.

WAVE IV will evaluate the safety and efficacy of Surround Sound in people with resistant hypertension, and will include a treatment arm for those who have failed alternate forms of renal denervation.

To date, 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 three quarters (75%) of patients at six months and an excellent safety profile. Data from the WAVE III study of non-invasive renal denervation will be presented at medical conferences this fall.

Roland Schmieder, Professor of Internal Medicine, Nephrology and Hypertension, University Hospital Erlangen, Germany and Principal Investigator for WAVE IV said: “With its novel approach, external ultrasound offers potential benefits over existing catheter-based renal denervation techniques. If proven successful, non-invasive 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.”

Michael Gertner, founder and CEO of Kona Medical noted: “This will be the first randomised, sham-controlled renal denervation trial since the Medtronic HTN-3 trial. We are excited to work with clinicians around the world to complete this important study.”

Surround Sound is investigational and is not yet approved for sale.