Feature | November 07, 2012

Kona Medical Announces Initiation of WAVE I Study of Renal Denervation Therapy for Hypertension

Kona Surround Sound Technology utilizes externally-delivered ultrasound to treat drug-resistant hypertension

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

Related Content

TCT 2016, TCT.16, main arena, late breaking trials
Feature | Cath Lab| September 28, 2016
September 28, 2016 — The Cardiovascular Research Foundation (CRF) has announced the 11 late-breaking trials and 16 fi
News | Pharmaceuticals| September 26, 2016
Nearly 2 out of 5 people with diabetes who could benefit from statin therapy to lower their risk of future heart attack...
smartphones, hospital tranfers, heart attack patients, JACC study, South Korea
News | Mobile Devices| September 23, 2016
Smartphone communication among medical teams at different hospitals can significantly reduce the time it takes for...
Medtronic, In.Pact Admiral drug-coated balloon, trial data, VIVA
News | Drug-Eluting Balloons| September 22, 2016
New data presented at the Vascular Interventional Advances (VIVA) conference demonstrated the durability, consistency...
Medtronic, CRT, cardiac resynchroniazation therapy devices, heart failure, medication adherence, retrospective analysis, HFSA 2016
News | Heart Failure| September 20, 2016
Medtronic plc announced the results of an analysis that reveals patients increasingly adhere to heart failure...
Valtech Cardio, Cardioband Tricuspid, Cardioband Mitral, PCR London Valves 2016, study data
News | Heart Valve Technology| September 19, 2016
Valtech Cardio Ltd. announced that it will present the first-in-man data for its Cardioband Tricuspid (TR) system at...
EBR Systems, FDA, WiSE Technology, Wireless Stimulation Endocardially, SOLVE-CRT study

The WiSE CRT System uses a tiny implant in the left ventricle to synchronize the heart, overcoming limitations of traditional cardiac resynchronization therapy (CRT) in heart failure patients. Graphic courtesy of Business Wire.

News | Cardiac Resynchronization Therapy Devices (CRT)| September 15, 2016
EBR Systems Inc. announced the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption...
News | Cardiac Diagnostics| September 13, 2016
September 13, 2016 — Results from a new study suggest that small molecules known as microRNAs may be part of the path
News | Cardiac Diagnostics| September 13, 2016
September 13, 2016 — Findings from a small...
News | Cardiac Diagnostics| September 12, 2016
A Saint Louis University researcher has received a grant to study the effects of treating post-traumatic stress...
Overlay Init