Dfine, a manufacturer of spinal disease treatment devices, has obtained CE Mark approval for its STAR tumor ablation system, designed to treat painful metastatic spinal tumors.
The STAR tumor ablation system uses radiofrequency (RF) energy and is capable of reducing the size of metastatic spinal tumors in a single, minimally invasive RF ablation procedure, providing rapid pain relief.
Earlier in 2010, the company received the US Food and Drug Administration (FDA) approval for the STAR system.
The system also demonstrated strong clinical outcomes at all centers in the US.
Dfine CEO Greg Barrett noted the company is very excited to bring this new treatment modality to Europe so that the hundreds of thousands of patients suffering from painful spinal tumors can receive the rapid pain relief that patients here in the US have experienced.
"This represents a significant milestone for the company," added Barrett.
The STAR system will be launched at the Cardiovascular and Interventional Radiological Society of Europe annual congress, from 14 September to 19 September 2013, in Barcelona, Spain.