On 4 May, Sound Interventions announced the successful completion of SOUND-ITV the company’s first-in-human clinical trial to treat resistant hypertension.
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 which could not be controlled with medical therapy. The SOUND-ITV study is focused on safety and effectiveness of Sound Interventions’ 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, chairman, Department of Cardiology, Holmolka Hospital. “The procedures highlighted the ease with which the system and the ultrasound energy may be delivered, minimising the number of applications of energy and the procedure time.”
Vivek Reddy, Mount Sinai Medical Center, New York, 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.”