09.16.13
San Jose, Calif.-based Dfine Inc., which makes targeted, minimally invasive spine pine disease treatments, has received the CE mark for its Star tumor ablation system. The company launched the device in the European Union at the Cardiovascular and Interventional Radiological Society of Europe held from Sept. 14-19.
The Star system received 510(k) clearance in the United States in August 2010.
The system includes the SpineStar ablation instrument, a small steerable device that enters the vertebra in a minimally invasive manner. Temperature monitors located within the SpineSTAR Ablation Instrument are designed to provide the physician real-time information about the ablative process throughout the procedure. According to the company, the device destroys the tumor using heat, not only removing the tumor but also relieving pain in a single treatment. Spinal tumors can cause debilitating pain, in some instances rendering patients immobile.
“We are 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 U.S. have experienced,” said Greg Barrett, CEO of Dfine. “This represents a significant milestone for the company.”
There are more than 3.4 million new cancer diagnoses each year in Europe alone. When cancer is not found early, it can spread or metastasize to other parts of the body. Spinal tumors form in or around the vertebra near the spinal cord. It is estimated that 30-40 percent of cancer patients will likely develop metastatic spinal tumors.
The company recently named a new CEO.
The Star system received 510(k) clearance in the United States in August 2010.
The system includes the SpineStar ablation instrument, a small steerable device that enters the vertebra in a minimally invasive manner. Temperature monitors located within the SpineSTAR Ablation Instrument are designed to provide the physician real-time information about the ablative process throughout the procedure. According to the company, the device destroys the tumor using heat, not only removing the tumor but also relieving pain in a single treatment. Spinal tumors can cause debilitating pain, in some instances rendering patients immobile.
“We are 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 U.S. have experienced,” said Greg Barrett, CEO of Dfine. “This represents a significant milestone for the company.”
There are more than 3.4 million new cancer diagnoses each year in Europe alone. When cancer is not found early, it can spread or metastasize to other parts of the body. Spinal tumors form in or around the vertebra near the spinal cord. It is estimated that 30-40 percent of cancer patients will likely develop metastatic spinal tumors.
The company recently named a new CEO.