Completed Clinical Studies

WAVE I Study of Renal Denervation Therapy for Hypertension

WAVE I was the first-in-man single arm study evaluating the safety and efficacy of the Surround Sound Renal Denervation System for the treatment of resistant hypertension. Unlike other renal denervation methods which rely on a catheter-based procedure which emits energy through the wall of the renal artery, the Surround Sound system delivers ultrasound energy to the renal nerves externally. This targeted energy “surrounds” the artery and ablates the nerves located adjacent to the vessel.

Data presented at EuroPCR 2013 from WAVE I demonstrated that patients treated with the Surround Sound Renal Denervation System had no device-related serious adverse events and experienced an average 22 mmHg drop in systolic blood pressure and 9 mmHg drop in diastolic blood pressure at three months and a 29 mmHg drop in systolic blood pressure and 12 mmHg drop in diastolic blood pressure at six months following treatment (N=24).

The clinical study participants included:

  • Robert Whitbourn, MD, Primary Investigator at St. Vincent’s Hospital in Melbourne, Australia
  • Petr Neuzil, MD, Primary Investigator at Nemocnice NA Homolce in Prague, Czech Republic
  • Zdenek Starek, MD, Primary Investigator at St. Anne’s Hospital, Brno, Czech Republic
  • Dr. Murray Esler of Baker Heart and Diabetes Institute in Melbourne, Australia served as norepinephrine core lab director.

WAVE II Study of Renal Denervation Therapy for Hypertension

The WAVE II single arm clinical study also evaluated the safety and efficacy of the Surround Sound Renal Denervation System for the treatment of resistant hypertension. The WAVE II clinical study utilized a dosing pattern that reduced the therapy delivery time from thirteen minutes per patient side to less than three minutes when compared with WAVE I.

The three month results from the WAVE II clinical study were presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in October 2013. The data from WAVE II demonstrated that resistant hypertension patients treated with the Surround Sound system experienced a 19.4 mmHg drop in systolic blood pressure and a 6.5 mmHg drop in diastolic blood pressure at three months following treatment (N=17).

The clinical study participants included:

  • Robert Whitbourn, MD, Primary Investigator at St. Vincent’s Hospital in Melbourne, Australia
  • Petr Neuzil, MD, Primary Investigator at Nemocnice NA Homolce in Prague, Czech Republic
  • Zdenek Starek, MD, Primary Investigator at St. Anne’s Hospital, Brno, Czech Republic
  • Dr. Murray Esler of Baker Heart and Diabetes Institute in Melbourne, Australia served as norepinephrine core lab director.

For the combined studies (WAVE I and WAVE II), a clinically significant drop in systolic blood pressure of 10 mmHg or more was reported in 73% of patients at three months and 81% of patients at six months.

WAVE III

The WAVE III pilot study evaluated the safety and efficacy of non-invasive renal denervation using the Surround Sound Hypertension Therapy System. The proprietary technology used in WAVE III utilized ultrasound imaging to externally guide therapeutic ultrasound energy. This fully non-invasive, ultrasound-based renal denervation system does not require the use of a catheter, catheterization laboratory, x-rays, shielding, contrast media or other specialized equipment.
The data from the WAVE III study demonstrated that resistant hypertension patients treated with the Surround Sound system experienced a greater than 10 mmHg reduction in 83% of the patients and more than 20 mmHg reduction in 58% of the patients. The clinical study group included:

  • John Ormiston, MD, Primary Investigator at Mercy Angiography Auckland, New Zealand
  • Petr Neuzil, MD, Primary Investigator at Nemocnice NA Homolce in Prague, Czech Republic
  • Zdenek Starek, MD, Primary Investigator at St. Anne’s Hospital, Brno, Czech Republic

The WAVE III study data was presented at medical conferences in the fall of 2014.

For the combined studies (Wave I, II and III), the average blood pressure reduction was greater than 25mmHg. In addition, greater than 75% of the patients responded with a drop ≥ 10 mmHg and > than 50% of the patients had a drop of ≥ 20 mmHg.