Kona Medical has announced the initiation of the first clinical study of its device therapy for drug-resistant hypertension. The Kona Surround Sound system utilises focused ultrasound, delivered from outside the body, to treat the nerves leading to and from the kidney.
WAVE I is now enrolling subjects at St Vincent’s Hospital in Melbourne, Australia, under the direction of Robert Whitbourn, primary investigator. The study design and initial results of WAVE I will be presented on behalf of the investigators by Todd Brinton at the TCT congress.
Unlike other renal denervation methods which rely on a catheter emitting therapeutic energy through the wall of the renal artery to affect the renal nerves, the Surround Sound technology uses a novel method of treating the nerves from outside the patient. A transducer positioned outside the body delivers targeted ultrasound energy that surrounds the artery and treats the nerves located in the vicinity of the vessel. By creating a focused energy field around the outside of the artery, the Kona system may result in a more complete and effective ablation in a way that does not impact the walls of the artery.
“Renal denervation is becoming one of the fastest-growing interventional therapies,” said Whitbourn. “The Kona system has the potential to further improve clinical results, and may also lead to improved access to renal denervation therapy. We are pleased to be participating in the evaluation of the Kona system and anticipate reporting complete study results next spring.”
Kona Medical’s technology is investigational and is not yet for sale or approved by the US Food and Drug Administration.