RF Medical has received the US Food and Drug Administration (FDA) approval for its patented MYGEN M-3004 generator and MYOBLATE radiofrequency ablation system.
The MYGEN M-3004 is a medical device that enables a combination of monopolar and bipolar modes to deliver radiofrequency energy.
In addition, the device supports optimised algorithm modes for use in a variety of lesions, based on their size and shape.
MYOBLATE electrodes are intended for coagulation and ablation of soft tissue to treat fibroids in a minimally invasive manner.
The device uses radiofrequency ablation (RFA), a therapeutic form of heat-treatment approach to safely treat fibroids individually while keeping the uterus intact.
RF Medical said that MYGEN and MYOBLATE devices will support medical facilities and practices, and will enhance the standard of care for minimally-invasive practices in the US.
With the FDA approval in place, the two products are now commercialised in the US.
RF Medical chief executive officer Mike Jun said: “The world’s medical device market is showing remarkable growth driven by cutting-edge minimally invasive technology and its industrial value is limitless. RF Medical is working diligently in an effort to keep pace with the advanced medical market.
“Improving the health and safety of mankind is our top priority and we are dedicated to carrying our mission as a leading medical device company through continuous investments in superior workforce and R&D.”
The South Korean medical device firm manufactures thermal ablation systems and is the creator of the MYGEN M-3004 generator and MYOBLATE electrodes.
According to the company, MYOBLATE is the only radiofrequency ablation system available for the treatment of uterine fibroids that uses a wide range of approaches.
The FDA approval provides an alternative treatment option for women with uterine fibroids.
A recent study found that around 70-80% of women experience this condition at some point.
The MYOBLATE system will be a less-invasive and more patient-friendly alternative to hysteroscopy or myomectomy.
