Surround Sound Renal Denervation System results for Resistant Hypertension
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 energy.