Guided Therapy Systems, based in Mesa, Arizona, landed EU CE mark approval (via Ardent Sound Inc., Guided’s partner and manufacturer) for the Actisound Intense Therapeutic Ultrasound device. It’s intended to help recover from a variety of injuries and chronic pain resulting from internal soft tissues.
The device is used to create small ablations within the tendons, ligaments, and other soft tissues in order to promote the growth of new connective tissue. This technology is intended to be an option over more invasive or less focused laser, microwave, and RF energy sources, as well as surgery, shockwaves, tenotomies, platelet rich plasma, and stem cell therapies.
The ultrasound device can target tissues up to 15 millimeters below the skin. Each procedure lasts about ten minutes and only one or two is expected to be needed for most patients. Inflammation and pain reduction typically happens within three days and tissue repair within a few weeks.
According to Guided Therapy Systems, three clinical studies have demonstrated that over 80% of patients treated had significant pain reduction and improvement in movement and joint function.
“CE mark is the result of many years of rigorous research, development and clinical testing. Starting today, Clinicians can offer a better, safer, and more efficient healing process,” in a statement said Michael Slayton, Ph.D, founder and CEO of Guided Therapy Systems. “Actisound’s Intense Therapeutic Ultrasound represents a completely new treatment option that wasn’t before available to chronic patients, and it’s the only option (outside of conservative therapies) that doesn’t include painful or costly procedures.”