DFINE ANNOUNCES FIRST COMMERCIAL CASES WITH STAR TUMOR ABLATION SYSTEM IN EUROPE
San Jose, Calif. – October 9, 2013 – 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 STAR™ Tumor Ablation System
t-RFA with the STAR System does not treat cancer. It is cleared by the FDA for providing palliative treatment (e.g. pain relief) by ablation of metastatic malignant tumors in a vertebral body. For a complete list of indications, risks and contraindications, visit http://www.dfineinc.com/Product-Risk—SpineSTAR
About DFINE, Inc.
DFINE is dedicated to relieving pain and improving the quality of life for patients suffering from spinal diseases through innovative, minimally invasive therapies. The company’s flagship products, the StabiliT® Vertebral Augmentation System and STAR™ Tumor Ablation System, represent generational advancements in the minimally invasive treatment of spinal diseases. DFINE is based in San Jose, Calif. and is a privately held company. DFINE and StabiliT are registered trademarks and STAR and Targeted Radiofrequency Ablation (t-RFA) are trademarks of DFINE, Inc.