Kona Surround Sound®Technology Utilizes Externally-Delivered Ultrasound to Treat
BELLEVUE, Wash. & MENLO PARK, Calif.--(BUSINESS WIRE)--
Kona Medical announced that three month results from the WAVE II study
and complete six month results for the WAVE I (first-in-man) study were
presented at the Transcatheter Cardiovascular Therapeutics Conference
today by Petr Neuzil, MD, of NA Homolce Hospital in Prague, Czech
Republic. Data presented from WAVE II demonstrated that resistant
hypertension patients treated with the Surround Sound® Renal
Denervation System experienced a 19.4 mmHg drop in systolic blood
pressure and 6.5 mmHg drop in diastolic blood pressure at three months
(N=17). For WAVE I, patients experienced blood pressure reductions of 22
/ 9 mmHg at three months and 29 / 12 mmHG at six months (N=24). For the
combined studies, 73% of patients experienced a clinically significant
drop in systolic blood pressure of 10 mmHg or more at three months and
81% at six months. There were no device related serious adverse events
in WAVE I or WAVE II.
WAVE II utilizes a dosing pattern that reduces therapy delivery time
from thirteen minutes per patient side to less than three minutes when
compared with WAVE I.
The study sponsor, Kona Medical, also announced the initiation of the
WAVE III study. WAVE III is evaluating the use of non-invasive
ultrasound imaging to guide externally-delivered therapeutic ultrasound
“Data from the WAVE I and WAVE II studies continue to indicate the
effectiveness of external ultrasound as a method of renal denervation,”
Dr. Neuzil reported. “The great promise of this technology is the
opportunity to treat hypertension patients outside the cath lab, without
the use of catheters, invasive instruments or radiation. We look forward
to the future results from the WAVE III study.”
Michael Gertner, MD, founder and CEO of Kona Medical added, “I thank the
WAVE I and WAVE II study teams for their commitment to this important
The clinical study group included St. Vincent’s Hospital in Melbourne,
Australia (Dr. Robert Whitbourn, Primary Investigator), Nemocnice NA
Homolce in Prague, Czech Republic (Dr. Petr Neuzil, Primary
Investigator), and St. Anne’s Hospital, Brno, Czech Republic (Dr. Zdenek
Starek, Primary Investigator). Dr. Murray Esler of Baker Heart and
Diabetes Institute served as norepinephrine core lab director.
About Kona Medical
Kona Medical’s Surround Sound® Renal
Denervation System utilizes ultrasound, delivered from outside the body,
to treat nerves leading to and from the kidney. Renal denervation has
been shown in clinical studies to lead to significant and lasting
reductions in blood pressure in drug-resistant hypertension patients.
Kona’s non-invasive system offers the opportunity to increase patient
access to renal denervation and lower healthcare costs. Kona is based in
Bellevue, Washington, and Menlo Park, California.
For additional information, please visit www.konamedical.com.
Note: Kona Medical’s technology is investigational and is not yet for
sale or approved by the US Food and Drug Administration.
Kona Medical, Inc.
Chief Operating Officer
Source: Kona Medical, Inc.