Guided Therapy Systems has received CE Mark approval via development partner and manufacturer, Ardent Sound, for its Intense Therapeutic Ultrasound (ITU) Actisound device.
Actisound Intense Therapeutic Ultrasound (ITU) acts like an invisible scalpel, working beneath the surface of the skin and precisely delivering small thermal ablations to tendons, ligaments, and other soft tissue to stimulate collagen growth and the regeneration of connective tissue.
Unlike other energy sources, such as laser, microwave and radio frequency; ultrasound is the only energy source that can penetrate safely through intervening tissue and be focused to a specific point and shape within the body.
This allows physicians the unique ability to deliver treatments directly at the point of injury, up to depths of 15 mm, without ever opening the patient.
Currently, Actisound is the only non-invasive, ablative treatment for pain relief associated with the repair of musculoskeletal injuries available to medical professionals.
“This CE mark is the result of many years of rigorous research, development and clinical testing”, said Michael Slayton, founder and chief executive of Guided Therapy Systems.
“Starting today, Clinicians can offer a better, safer, and more-efficient healing process.
“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.”
Common therapies such as NSAIDS and steroid injections only temporarily reduce pain without addressing the underlying injury.
And procedures like shockwave and minimally-invasive tenotomy, PRP and stem cell injections can be very costly and painful.
Traditional surgeries are even more expensive – requiring longer recovery and down time and exposing patients to a number of complications.
With Actisound, no cutting or painful injections are required, and the treatment can be delivered right in the physician’s office.
Actisound is affordable and fast, requiring only one or two 10-minute treatments and typically resulting in reduced pain and inflammation within 48-72 hours and soft tissue repair within 4-12 weeks.
Three multi-centre clinical studies have shown that more than 80% of chronic patients with length of persisting pain averaging 15.7 months experienced a significant reduction in pain combined with increased function and mobility compared to traditional methods