DFINE ANNOUNCES FIRST U.S. PATIENT TREATED WITH THE STAR™ ABLATION SYSTEM
Landmark Interventional Oncology Procedure at University of Louisville Marks Initial Rollout of Therapy to Treat Spine Tumors
SAN JOSE, CALIF. – March 14, 2012 – DFINE, Inc.
, the developer of minimally invasive radiofrequency (RF) targeted therapies for the treatment of vertebral pathologies, today announced the first U.S. patient was successfully treated using the Spinal Tumor Ablation with Radiofrequency (STAR™) System. The FDA-commercially cleared, percutaneous Targeted RadioFrequency Ablation (t-RFA™) device delivers energy directly into a metastatic vertebral body tumor to heat and destroy tumor cells and provide palliative pain relief.
The first procedure marks the initial rollout of the DFINE STAR System, which will initially be available in a limited number of centers throughout the U.S., with full commercial availability expected in autumn 2012.
"This therapy has made a world of difference for our patient,” said Douglas Coldwell, MD, Director of Vascular and Interventional Radiology at the University of Louisville Hospital/James Graham Brown Cancer Center, who performed the first procedure. "Shortly after the treatment, the patient’s mobility improved, and just hours after the outpatient procedure, his pain was significantly reduced. Due to this treatment, he will be more comfortable with additional therapy for his primary cancer. The targeted delivery of RF energy has the potential to provide the fastest relief from painful metastatic spine tumors. We are pleased to be the first U.S. center to offer this revolutionary therapy."
Because RF energy does not directly stimulate nerves or muscles, as do other types of energy delivering devices, RF ablation therapies have been effectively used to treat soft tissue diseases in the heart, lungs, kidneys, breast, liver, and various other sites throughout the body.
The STAR System, using t-RFA, is a dramatic step forward in the palliative treatment of metastatic spinal tumors of vertebral bodies. Unlike other currently available ablation tools designed for soft tissue, the STAR System was developed specifically to treat metastatic spine tumors.
“This is an exciting development that will offer physicians new, targeted options when treating patients suffering from the debilitating effects of spinal tumors,” said Virginia Kaklamani, MD, Director of Translational Breast Cancer Research and Co-director of the Cancer Genetics Program at Northwestern University.
Metastatic bone disease occurs in up to 85 percent of patients with the three most common types of primary cancer – breast, prostate and lung.1
The spine is the most common site for bone metastases, with studies showing that metastatic spinal tumors will develop in between 10 percent and 40 percent of all cancer patients, with even higher rates in elderly patients.2
Several post-mortem studies have found metastatic spinal tumors in over 30 percent of all patients who died as a result of cancer and cancer-related causes.3,4
Beyond narcotic administration for pain management and conservative treatment, the primary modality for treating painful spinal metastases has been external beam radiation, which when effective, may require weeks or months to address the associated pain and disability. In addition, radiation therapy often requires patients suspend chemotherapy treatment of the primary cancer due to the potential effects of cumulative toxicity. The benefits of t-RFA using the STAR System include:*
1 Kurup AN and Callstrom MR. Ablation of skeletal metastases: Current status. J Vasc Interv Radiol. 2010;21:S242-S250.
- Minimally invasive procedure that can be performed on an outpatient basis and requires only a small surgical incision
- Designed to ablate the patient’s vertebral body lesion with the intent to provide palliative pain relief
2 Cardoso ER, et al. Percutaneous tumor curettage and interstitial delivery of samarium-153 coupled with kyphoplasty for treatment of vertebral metastases. J. Neurosurg Spine 2009;10:336-342.
3 Wong DA, Fornasier VL, and MacNab I. Spinal metastases: the obvious, the occult, and the impostors. Spine. 1990;15(1):1-4.
4 Ortiz Gómez JA. The incidence of vertebral body metastases. Int Orthop. 1995;19:309-311.
- May minimize delay in systemic therapy (i.e. chemotherapy) of the primary cancer.
- Potentially minimizes vertebral body damage due to radiation-related bone fragility, and the overall effects of radiation, including resistance, alopecia, xerostomia and nausea.5
“Our goal is to work closely with the interventional and oncology professional communities to obtain clinical evidence and continually advance our knowledge in the role of t-RFA with the STAR System in the palliative treatment of patients with painful vertebral body metastasis,” said Kevin Mosher, Chief Executive Officer of DFINE. “We anticipate our RF platform will pave the way for additional applications, positioning the company for significant growth into the largely unexplored field of interventional oncology, as it relates to vertebral body spine lesions and other bony metastases.”
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
For DFINE, Inc