Dfine, Inc. Receives CE Mark Approval for Star Tumor Ablation System
European Launch at CIRSE Annual Congress
SAN JOSE, Calif., Sept. 12, 2013 -- DFINE, Inc., a fast-growing market leader in the treatment of spinal diseases, today announced it has received CE Mark approval for the STAR™ Tumor Ablation System for treatment of painful metastatic spinal tumors. The company will launch the STAR System in Europe at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Congress (Booth #12). CIRSE, the world's largest and most prestigious conference in the field of minimally invasive image-guided therapies, will be held in Barcelona, Spain Sept. 14 – 19, 2013.
The STAR System received 510k clearance in the United States in August 2010 and has demonstrated strong clinical outcomes at centers across the country.
“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. This represents a significant milestone for the company,” said Greg Barrett, Chief Executive Officer of DFINE.
About Metastatic Spinal Tumors
Cancer is a major public health problem throughout the world, with more than 3.4 million new diagnoses each year in Europe alone.1 When cancer is not found early, it can spread or metastasize to other parts of the body. A spinal tumor is a growth of cells (mass) 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.2
Patients suffering from painful spinal tumors have limited options. Many are in excruciating pain and unable to perform activities of daily living. Targeted RF ablation (t-RFA) with the STAR Tumor Ablation System was developed specifically for metastatic vertebral body tumors. The physician can target precisely where the device’s energy is delivered to heat and destroy the tumor, providing rapid and lasting pain relief in a single treatment.
1 Bray F, Ren HS, Masuyer E, Ferlay J. Estimates of global cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar1;132(5):1133-45. Epub 2012 Jul 26
2 Medscape Reference: Victor Tse, MD, PhD; Chief Editor: Stephen A Berman, MD, PhD, MBA, et al.
About DFINE, Inc.
DFINE is dedicated to relieving pain and improving the quality of life for patients suffering from vertebral pathologies through innovative, minimally invasive therapies. DFINE's devices are built upon an extensible radiofrequency (RF) platform. Cleared for commercial use by the Food and Drug Administration (FDA), the first application was the StabiliT® Vertebral Augmentation System and StabiliT® ER2 Bone Cement, which harness the power of radiofrequency energy to treat pathological fractures of the vertebrae. The company subsequently received FDA 510(k) commercial clearance for its second application, the STAR™ Ablation System, for palliative treatment in spinal procedures to ablate metastatic malignant lesions in a vertebral body. The STAR system will be commercially released later this year. DFINE is based in San Jose, Calif. and is a privately held company.
Susan Benton Russell
Posted: September 2013