DFine Announces FDA 510(k) Clearance of New Radiofrequency Ablation System for Metastatic Spinal Lesions
SAN JOSE, Calif.–(BUSINESS WIRE)–DFine, Inc., developer of minimally invasive solutions for the treatment of vertebral pathologies, announced today the 510(k) clearance of a new platform extension indicated for the palliative treatment of cancer patients. The product, a percutaneous radiofrequency ablation (RFA) device, provides localized tumor necrosis of vertebral body lesions where metastatic disease has spread to the spine causing severe pain and discomfort.
“The device contains a flexible tip that allows for targeted ablation of metastatic lesions in any location within the vertebral body using a unipedicular approach. Delivery of controlled, heat energy to vertebral metastases enables tumor necrosis providing the potential for substantial pain relief.”
Spinal metastasis affects over 400,000 patients and 850,000 vertebrae each year worldwidei. Beyond narcotic administration, the primary modality for treating painful spinal metastases is external beam radiation which when effective, may require weeks or months to address the associated pain and disability. In addition, radiation therapy often requires that patients suspend chemotherapy treatment of the primary cancer due to cumulative toxicity. The ability to provide localized RFA of metastatic lesions of the spine can provide immediate and lasting pain relief, allowing these patients an improved quality of life and minimal, if any, delay in systemic, curative therapy of their primary cancer.
Commenting on the announcement, Kevin Mosher, Chief Executive Officer of DFine Inc., said, “This regulatory clearance expands DFine’s technology platform, providing additional areas of opportunity and growth for the company. RFA has been routinely utilized to debulk tumors of the liver and kidney, and several studies have shown its efficacy in treating osseous metastatic disease. The unique design of DFine’s RFA system incorporates a navigational electrode which helps overcome many of the technical limitations of current devices on the market. Advantages include a tight, well defined ablation zone, and full access to the vertebral body via a unipedicular approach. Early clinician feedback has been extremely positive.”
Professor Andreas Kurth, a contributor to the product’s development based at University Medical Center in Mainz, Germany, commented, “Bone metastases of the spine are a debilitating complication which are usually treated by surgery or limited dose radiotherapy. This product has the ability to improve the treatment of a significant number of patients with advanced stage cancer.”
Dr. Bassem Georgy, Assistant Professor of Radiology at University of California, San Diego, who has published several pioneering papers on the treatment of painful metastatic spinal lesions commented, “The device contains a flexible tip that allows for targeted ablation of metastatic lesions in any location within the vertebral body using a unipedicular approach. Delivery of controlled, heat energy to vertebral metastases enables tumor necrosis providing the potential for substantial pain relief.”
About DFine
Based in San Jose, CA, DFine, Inc. is a privately held medical device company dedicated to improving patient quality of life through the development of innovative, minimally invasive therapeutic devices used to treat pathologies of the vertebrae. DFine, Inc. is the developer of Radio Frequency (RF) Kyphoplasty, a novel approach to stabilizing vertebral fractures, relieving pain and improving patient quality of life. Commercially available through the company’s flagship StabiliT® Vertebral Augmentation System, RF Kyphoplasty provides physicians greater control in the treatment of vertebral compression fractures through site and size specific cavity creation, ultra high viscosity bone cement with extended working time, and its unique, remotely controlled cement delivery system. For more information, visit www.dfineinc.com.
