November 7, 2012 — Kona Medical Inc. announced the initiation of the first clinical study of its device therapy for drug-resistant hypertension. The company is sponsoring the WAVE I clinical study to evaluate the safety and efficacy of its novel technology, and is now enrolling subjects at St. Vincent’s Hospital in Melbourne, Australia, under the direction of primary investigator Robert Whitbourn, M.D. The study design and initial results of WAVE I were presented on behalf of the investigators by Todd Brinton, M.D., at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) conference.
The Kona Surround Sound system utilizes focused ultrasound, delivered from outside the body, to treat the nerves leading to and from the kidney. The therapy of renal denervation has been shown in other studies to lead to significant and lasting reductions in high blood pressure. 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, Kona’s 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.”
“Initiation of the WAVE I study is an important milestone in the development of therapies for hypertension,” added Michael Gertner, M.D., founder and CEO of Kona Medical. “Ultrasound has inherent advantages as an energy source for ablation, and we believe that external delivery of ultrasound energy better addresses the variability of the location of renal nerves and may lead to better outcomes. Importantly, focused external ultrasound also can enable a system that is entirely noninvasive. This could greatly expand access to renal denervation therapy, and would offer a more patient-friendly alternative for the tens of millions of people who suffer from drug-resistant hypertension.”
Kona Medical’s technology is investigational and is not yet for sale or approved in the United States.
For more information: www.konamedical.com