Sanuwave Health has launched orthoPACE device in Europe following CE mark approval, for use in orthopedic, trauma and sports medicine indications. The compact portable design of the device allows for expanded treatment potential in both hospital and office settings.
The orthoPACE incorporates the company’s proprietary Pulsed Acoustic Cellular Expression (PACE) technology platform that delivers extracorporeal shock wave technology (ESWT) to treat a wide variety of chronic and acute conditions in hard and soft tissue.
Sanuwave Health said that the device platform generates high energy, electrohydraulic shock waves that activate biological signaling and angiogenic responses, including revascularisation and microcirculatory improvement, helping restore the body’s normal healing processes and promote regeneration.
The orthoPACE device features a new applicator that is less painful for some indications and may reduce or completely eliminate anesthesia for some patients.
Sanuwave said that PACE treatment is completely non-invasive so there is no risk of infection or scarring. It preserves the opportunity for any future treatment options as it does not change the biomechanics of the underlying musculoskeletal system.
In addition to the PACE platform’s orthoPACE introduction, Sanuwave has developed dermaPACE, its lead product candidate for the global wound care market.
The dermaPACE is CE marked for treatment of the skin and subcutaneous soft tissue and has completed enrollment in its FDA-approved Phase III, pivotal, Investigational Device Exemption (IDE) trial in the US for the treatment of diabetic foot ulcers (DFU). The dermaPACE US DFU study is currently in the patient follow-up phase.
Christopher Cashman, president and CEO of Sanuwave, said: “The orthoPACE device offers significant enhancements to our past successful legacy orthopedic products, including the Ossatron. The orthoPACE offers the best aspects and the same solid clinical efficacy, along with new features and expanded treatment potential.
“The orthoPACE has been well received by our European distributors and clinicians, and we expect the product to continue to gain visibility and momentum in 2010.”