US-based Kona Medical has started a randomised, sham-controlled, double-blinded WAVE IV clinical trial of its non-invasive surround sound system for the treatment of hypertension (high blood pressure) and other disorders.
A total of 132 subjects at sites in Europe, New Zealand, Australia and South America will be enrolled in the trial, which will include a treatment arm for those who have failed alternate forms of renal denervation.
The Kona surround sound system uses ultrasound, delivered from outside the body, to treat nerves leading to and from the kidney.
The system uses ultrasound imaging to guide the external delivery of focused ultrasound energy to specific target tissue that automatically tracks movement and enables continuous therapy delivery.
The trial will evaluate the safety and efficacy of surround sound in people with resistant hypertension.
So far, approximately 69 patients have been treated with surround sound across three clinical trials, including WAVE I, WAVE II and WAVE III.
University Hospital Erlangen professor of internal medicine, nephrology and hypertension, and principal investigator for WAVE IV Dr Roland Schmieder said: "We are pleased to participate in this randomised, sham-controlled trial of Kona Medical’s non-invasive therapy for resistant hypertension.
"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."
Data from the WAVE I and WAVE II trials showed a response in about three quarters (75%) of patients at six months and an excellent safety profile.
The company intends to report data from the WAVE III trial of non-invasive renal denervation in fall this year.
Kona Medical founder and CEO Michael Gertner said: "Initiation of WAVE IV is an important milestone in the development and commercialisation of Surround Sound.
"This will be the first randomised, sham-controlled renal denervation trial since the Medtronic HTN-III trial.
"We are excited to work with clinicians around the world to complete this important study."
The company has developed an ultrasound-based platform which allows non-invasive imaging, targeting, tracking and treatment of soft tissue structures throughout the body without radiation and without the cost or complexity of MR and other technologies.