Kona Medical’s two ongoing WAVE studies demonstrated the ability of focused ultrasound to noninvasively reduce blood pressure in patients with drug-resistant hypertension. Renal nerve ablation with their focused ultrasound—based Surround Sound™ Renal Denervation System produced clinically significant drops in both systolic and diastolic blood pressure. 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 with no device-related serious adverse events. As impressive as the drop in blood pressure, the WAVE II study also uses a dosing pattern that reduced therapy time from 13 minutes to 3 minutes.
“Data from the WAVE I and WAVE II studies continue to indicate the effectiveness of external ultrasound as a method of renal denervation,” said Petr Neuzil, MD, Primary investigator at NA Homolce Hospital in Prague, Czech Republic. Dr. Neuzil continued, “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.”
In addition to Nemocnice NA Homolce in Prague, Czech Republic, the clinical study group included St. Vincent’s Hospital in Melbourne, Australia (Dr. Robert Whitbourn, 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.
Kona Medical was recently named one of Fierce Medical Devices 2013 “Fierce 15,” an honor given to the top medical device and diagnostic companies for innovation, drive, and market-changing technology. For more information from Kona Medical, including a Q&A with Founder and CEO Michael Gertner, click here.