San Jose, Calif. and Magdeburg, Germany – June 11, 2014 – DFINE®, Inc., a market leader in the minimally invasive treatment of spinal diseases, today announced that the first patient has been enrolled in the EU-STAR Clinical Trial. The multi-center trial is the first prospective study to evaluate clinical outcomes in patients receiving treatment with the STAR™ Tumor Ablation System for the palliative treatment of metastatic spinal tumors.
DFINE will enroll 40 patients at five centers in Germany and France. The trial will evaluate pain relief at one month as a primary outcome measure with follow up through six months. Secondary outcome measures include change in function, quality of life and pain medications post-procedure.
“We’ve had very promising results with targeted RF ablation (t-RFA™) to ‘melt’ the tumor followed by RF targeted vertebral augmentation™ (RF-TVA) during the same procedure to repair the damaged vertebrae,” said Dr. Boris Joellenbeck, a principal investigator at The Otto-von-Guericke University Magdeburg in Germany, where the first patient was treated. “Immediately following the procedure, the patient had a significant reduction in pain and increased activity level. We are excited about the many potential benefits of this therapeutic approach for our patients.”
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 metastasize (spread) 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 Many of these tumors also result in fractures of the vertebrae.
“t-RFA and RF-TVA provide an innovative new treatment option for the many patients worldwide who suffer from the debilitating effects of spinal tumors,” said Greg Barrett, Chief Executive Officer of DFINE. “As a company we are committed to building a body of scientific evidence supporting the therapy and are excited to partner with several leading medical centers in Germany and France on this landmark trial.”
To learn more about the EU-STAR clinical trial (ID # NCT02081053), interested parties may contact the study research staff found here: http://www.clinicaltrials.gov/ct2/show/NCT02081053
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. [media-contact]
- 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 sMar1;132(5): 1133-45 PubMed: 22752881
- Gerszten PC, Welch WC, et al. Combined percutaneous transpedicular tumor debulking and kyphoplasty for pathological compression fractures Technical note. J Neurosurg: Spine. 2007 s6: 92-95
- Boehling NS, Grosshans DR, et al. Vertebral compression fracture risk after stereotactic body radiotherapy for spinal metastases. J Neurosurg: Spine. 2012 s16(4): 379-386