News | November 13, 2013

WAVE I, WAVE II Studies of Renal Denervation Therapy Show Improvements in Hypertension

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

November 13, 2013 — Petr Neuzil, M.D., Nemocnice Na Homolce Hospital, Prague, Czech Republic, presented three-month results from the WAVE II study and complete six-month results for the WAVE I (first-in-man) at the Transcatheter Cardiovascular Therapeutics conference (TCT 2013). Data 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 percent of patients experienced a clinically significant drop in systolic blood pressure of 10 mmHg or more at three months and 81 percent 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 13 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 energy.
“Data from the WAVE I and WAVE II studies continue to indicate the effectiveness of external ultrasound as a method of renal denervation,” said Neuzil. “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.”
The clinical study group included St. Vincent’s Hospital in Melbourne, Australia  (Robert Whitbourn, M.D., primary investigator), Nemocnice Na Homolce Hospital, Prague, Czech Republic (Neuzil) and St. Anne’s Hospital, Brno, Czech Republic (Dr. Zdenek Starek, Primary Investigator). and Dr. Murray Esler, Baker Heart, Diabetes Institute and core lab director of norepinephrine.
For more information:

Related Content

American College of Cardiology Expands Patient Navigator Program
News | Cath Lab | March 21, 2018
March 21, 2018 — Hundreds of hospitals across the United States will have access to tools and resources to help impro
Videos | Cath Lab | March 15, 2018
A discussion with Hitinder Gurm, M.D., MBBS, FACC, professor, internal medicine, and associate chief clinical officer
News | Cath Lab | February 27, 2018
The American College of Cardiology (ACC) and the Saudi Arabian Cardiac Interventional Society have partnered to...
News | Cath Lab | February 23, 2018
February 23, 2018 — CorFlow Therapeutics AG announced that the company will present new insights into the coronary mi
Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Overlay Init