News | May 09, 2012

Sound Interventions Completes First-In-Human Trial of Ultrasound-Based Renal Denervation System

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

Related Content

Thermedical Announces FDA IDE Approval for Clinical Study of Durablate Catheter
News | Ablation Systems | August 02, 2018
Thermedical announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device...
Boston Scientific to Acquire Cryterion Medical Inc.
News | Ablation Systems | July 13, 2018
Boston Scientific Corp. recently announced a definitive agreement to acquire Cryterion Medical Inc., a privately-held...
Treating AFib With Ablation Reduces Mortality and Stroke
News | Ablation Systems | July 05, 2018
Using catheter-based ablation instead of medications alone reduces the risks of death and stroke in patients with the...
LuxCath Showcases OmniView Light-Guided Ablation Catheter at HRS 2018
News | Ablation Systems | May 22, 2018
LuxCath LLC showcased the next generation of its proprietary OmniView light-guided catheter ablation system at the 2018...
The Kardium Globe combined mapping and ablation catheter. The device has a distal multi-electrode array consisting of 16 ribs with 122 gold-plated electrodes. Ablation can be done with up to 24 electrodes simultaneously.  #HRS2018

The Kardium Globe combined mapping and ablation catheter. The device has a distal multi-electrode array consisting of 16 ribs with 122 gold-plated electrodes. Ablation can be done with up to 24 electrodes simultaneously. 

News | Ablation Systems | May 21, 2018
May 21, 2018 — Complete pulmonary vein isolation (PVI) was achieved in more than 99 percent of patients in a first-in
CardioFocus Announces Successful Live Case Featuring HeartLight X3 System
News | Ablation Systems | May 17, 2018
Medical device manufacturer CardioFocus Inc. announced a successful live case featuring its HeartLight X3 System during...
Imricor MRI-Guided Cardiac Ablation Study Results to Be Presented at HRS 2018
News | Ablation Systems | May 10, 2018
Results from the clinical study to evaluate Imricor’s Vision-MR Ablation Catheter for the treatment of atrial flutter...
Biosense Webster Launches Carto Vizigo Bi-Directional Guidance Sheath
Technology | Ablation Systems | May 08, 2018
Biosense Webster Inc. announced its Carto Vizigo Bi-directional Guiding Sheath is now available in the United States....
Stereotaxis and Acutus Medical Announce Strategic Collaboration
News | Ablation Systems | May 04, 2018
Stereotaxis and Acutus Medical announced a strategic collaboration to integrate the Stereotaxis Niobe Magnetic...
Medtronic Cryoballoon Shows Positive Results for Patients With Persistent Atrial Fibrillation
News | Ablation Systems | April 12, 2018
Medtronic plc announced one-year results from the CRYO4PERSISTENT AF study of ablation with the Arctic Front Advance...
Overlay Init