WAVE I, WAVE II Studies of Renal Denervation Therapy Show Improvements in 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: www.konamedical.com