Sound Interventions, Inc. today 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 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 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," stated Doc. MUDr. Petr 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."