Company Launches WAVE IV Randomized, Sham-Controlled Trial of Kona Surround Sound® System
BELLEVUE, WASHINGTON AND MENLO PARK, CALIFORNIA–(BUSINESS WIRE)—August 27, 2014. Kona Medical announced the initiation of the WAVE IV clinical trial of its non-invasive Surround Sound® Hypertension Therapy System. The randomized, sham-controlled, double-blinded trial will treat 132 subjects at sites in Europe, New Zealand, Australia, and South America.
Surround Sound utilizes ultrasound, delivered from outside the body, to treat nerves leading to and from the kidney. When hypertension is not adequately treated by lifestyle modifications and medication, these nerves may be overactive, contributing to high blood pressure. People with high blood pressure are more likely to suffer stroke, heart failure, coronary artery disease and other debilitating conditions. 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 6 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.
“We are pleased to participate in this randomized, sham-controlled trial of Kona Medical’s non-invasive therapy for resistant hypertension,” said Dr. Roland Schmieder, Professor of Internal Medicine, Nephrology and Hypertension, University Hospital Erlangen, Germany and Principal Investigator for WAVE IV. “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.”
“Initiation of WAVE IV is an important milestone in the development and commercialization of Surround Sound,” added Michael Gertner, MD, founder and CEO of Kona Medical. “This will be the first randomized, 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.”
For information about WAVE IV visit http://konamedical.com/clinical-studies.
Note: Surround Sound® is investigational and is not yet approved for sale.
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