SAN JOSE, Calif.--(BUSINESS WIRE)--DFINE, Inc., a fast-growing market leader in the treatment of spinal diseases, today announced the completion of the first European commercial cases with the STAR™ Tumor Ablation System for the palliative treatment of painful metastatic spinal tumors since the device received CE Mark approval last month.
The Targeted Radiofrequency Ablation (t-RFA) procedures using the STAR System were performed in Germany, Italy and the United Kingdom over the past two weeks.
According to Dr. Winston Rennie at the University of Leicester's Leicester Royal Infirmary who performed the first case in the UK, “t-RFA is one of the most innovative and exciting developments I have seen for the palliative treatment of painful spinal tumors in recent years,” he said. “The unique design of the STAR System allows me to deliver a very targeted and controlled ablation next to critical spinal structures, burn tumors and provide rapid pain relief in a single procedure. I was very pleased with the initial experience and can see a significant need for this in percutaneous cancer treatment and spine augmentation in the UK.”
The STAR System received 510k clearance in August 2010 and has demonstrated strong clinical outcomes in the U.S. and abroad. In September, the company announced the CE Mark approval and European product launch at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Congress.
“We are pleased with the very quick start in Europe and believe that it is indicative of the unmet clinical need for patients with painful spinal metastases,” said Greg Barrett, Chief Executive Officer of DFINE. “Our goal is to expand into centers across all European markets in an effort to make the therapy available to the many thousands of patients suffering from painful spinal tumors.”
About Metastatic Spinal Tumors and the STAR System
Cancer is a major public health problem throughout the world, with more than 3.4 million new diagnoses each year in Europe alone. 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.
Patients suffering from painful spinal tumors have limited options. Many are in excruciating pain and unable to perform activities of daily living. t-RFA with the STAR System was developed specifically for the palliative treatment of 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. This single, minimally invasive procedure may be compatible with both chemotherapy and radiation therapy.
About DFINE, Inc.
DFINE is dedicated to relieving pain and improving the quality of life for patients suffering from diseases of the spine through innovative, minimally invasive, targeted therapies. The company's devices are built on an extensible radiofrequency (RF) platform that currently covers two procedural applications: 1. The treatment of vertebral compression fractures (VCFs) with the StabiliT® Vertebral Augmentation System, and 2. the palliative treatment of metastatic vertebral body tumors with the STAR™ Tumor Ablation System. Both systems represent generational advancements in the minimally invasive treatment of vertebral pathologies. DFINE is based in San Jose, Calif. and is a privately held company. Stay connected with DFINE via Facebook or Twitter (@DFINEinc) or call 1.866.963.3463.
To see a demonstration of the STAR System, visit DFINE at the North American Spine Society (NASS) 28th Annual Meeting October 9-12, 2013 in New Orleans, Louisiana (Booth # 1737).
