May 30, 2013 — Kona Medical announced three and six month results from the WAVE I study, a first-in-man study evaluating the safety and efficacy of Kona Medical’s Surround Sound Renal Denervation System for the treatment of resistant hypertension.
Unlike other renal denervation methods, which rely on a catheter emitting energy through the wall of the renal artery, Kona’s system delivers ultrasound energy to the nerves from outside the body. This targeted energy “surrounds” the artery and treats the nerves located in the vicinity of the vessel. Data presented from WAVE I demonstrates that patients treated with the Surround Sound Renal Denervation System had no device-related serious adverse events and experienced a 22 mmHg drop in systolic blood pressure and 9 mmHg drop in diastolic blood pressure at three months (N=24). In those patients who had reached 6 months follow-up (N=14) there was a 29 mmHg drop in systolic blood pressure and 9 mmHg drop in diastolic blood pressure.
“The results from this initial study of external ultrasound for renal denervation are very promising,” said Robert Whitbourn, M.D., of St. Vincent’s Hospital in Melbourne, Australia. “Blood pressure reduction in this very severe hypertensive cohort grows over time. We’ve also seen that the ultrasound energy leads to effective denervation without any discernible effect on the renal artery. While more studies are required to confirm these results, external ultrasound appears to have strong potential as an alternative to catheter based energy delivery for patients with hypertension.”
Additional data reported on WAVE I includes:
- On average, clinical subjects had a baseline blood pressure of 190 mmHg systolic and 100 mmHg diastolic and were taking an average of 4.5 anti-hypertension medications.
- 11 out of 14 subjects (78 percent) reaching the six-month efficacy endpoint had a clinically significant drop in systolic blood pressure of 10 mmHg or greater.
- Results from norepinephrine spillover studies indicate strong evidence of sympathetic denervation.
- There were no adverse findings in the subjects’ renal vasculature based on six-week angiogram (n=9) and 24 week magnetic resonance imaging (MRI) (n=14).
Currently, the clinical sites are enrolling and treating subjects in a follow-on study, WAVE II, which utilizes an optimized treatment protocol that reduces therapy delivery time from approximately 12 minutes per side (in WAVE I) to under three minutes. Kona Medical also has announced plans to initiate the WAVE III study, which will evaluate the safety and efficacy of a fully external (non-invasive) version of its ultrasound-based therapy.
For more information: www.konamedical.com