Ultrasound-Based Renal Denervation System Studied for Resistant Hypertension

A new clinical human trial has just been completed that followed patients for 12 months to assess the effectiveness of an ultrasound-based renal denervation system in lowering blood pressure.

The study was focused on safety and effectiveness of Sound Interventions Inc.’s (Stony Brook, NY, USA) volumetric dosimetry-based application of unfocused ultrasound (patents pending). The company announced the successful completion of the company’s first-in-human clinical trial (SOUND-ITV) to treat resistant hypertension.

The study was performed by Dr. Petr Neuzil and a team of cardiologists at Homolka Hospital (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. 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,” stated Dr. Neuzil, CSc, FESC, chairman, department of cardiology of Homolka 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.”

Dr. Vivek Reddy, from Mt. Sinai Medical Center (New York, NY, USA), who is an advisor to Sound Interventions, commented, “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.”

Sound Interventions is a privately held emerging medical technology company focused on the development of therapeutic ultrasound for the treatment of resistant hypertension. Founded in 2010, Sound Interventions is located in the Long Island High Technology Incubator at Stony Brook (NY, USA).

Dr. Neuzil received financial support from Sound Interventions for the SOUND-ITV Study.

Related Links:
Homolka Hospital
Sound Interventions
Mt. Sinai Medical Center