May 9, 2012 — Sound Interventions Inc. announced the successful completion of the company's first-in-human renal denervation system clinical trial to treat resistant hypertension, SOUND-ITV.
The study was performed by Petr Neuzil and a team of cardiologists at Holmolka Hospital in Prague, Czech Republic. Patients enrolled in the study were selected based on a history of hypertension that could not be controlled with medical therapy. The SOUND-ITV study is focused on safety and effectiveness of the company's volumetric dosimetry-based application of unfocused ultrasound (patents pending). Patients enrolled in the study will be followed for 12 months to evaluate the procedure's effectiveness in lowering blood pressure.
"This study demonstrated the feasibility of the acute procedure," said Neuzil, CSc., FESC, chairman, department of cardiology of Holmolka Hospital. "The procedures highlighted the ease with which the system and the ultrasound energy may be delivered, minimizing the number of applications of energy and the procedure time."
Vivek Reddy, of Mount Sinai Medical Center in New York City and an advisor to Sound Interventions, said, "In addition to testing the effectiveness of ultrasound in lowering blood pressure, the study was designed to evaluate the ability of the technology to deliver a specific dose of ultrasound which is effective in affecting the renal sympathetic nerves, while sparing the renal artery from damage. We are encouraged by the complete lack of ultrasound-induced spasm in the renal arteries during these procedures. Spasm is a common occurrence when radiofrequency energy is delivered in the renal arteries."
"The successful completion of the treatment phase of the SOUND-ITV study is an important milestone for Sound Interventions, and brings us closer to our goal of commercialization of the Sound Interventions' technology," said David Smith, president and CEO of Sound Interventions. "While we await the important follow-up data from this series of patients, we continue to move forward with our plans for an expanded European trial."
For more information: www.sounditv.com