SAN JOSE, Calif.--(BUSINESS WIRE)--DFINE, Inc., the developer of minimally invasive radiofrequency (RF) targeted therapies for the treatment of vertebral pathologies, announced today the award of a five-year Federal Supply Schedule (FSS) contract from the U.S. Department of Veterans Affairs (V.A.). According to the terms of the contract, DFINE will supply the StabiliT® Radiofrequency Targeted Vertebral Augmentation™ (RF-TVA) System and all related products to treat vertebral compression fractures (VCFs) to the V.A. system, representing 950 facilities throughout the country.
“We are proud to have been selected by Veterans Affairs to provide DFINE’s innovative StabiliT system to treat patients who are suffering from VCFs,” said Kevin Mosher, chief executive officer of DFINE. “We appreciate the tremendous sacrifice our military personnel make and believe these individuals and their families should have access to RF-TVA, the most advanced, targeted therapy for the treatment of VCFs.”
According to the 2009 American Community Survey, there are approximately 22 million veterans in the United States. The median age for a World War II veteran in February 2009 was 86 years.1
An estimated 700,000 VCFs occur annually in the United States, and more than 80 percent of the patients who present are 65 years and older.1
About StabiliT® and Radiofrequency Targeted Vertebral Augmentation™ (RF-TVA)
The DFINE StabiliT Vertebral Augmentation system is the latest advancement in the treatment of vertebral compression fractures (VCFs). During the RF-TVA procedure, a small tube is placed into the fractured vertebra and a cavity is created. Ultra-high viscosity StabiliT® ER2 Bone Cement fills the cavity and permeates the surrounding bone to stabilize the fracture. With StabiliT, physicians are able to navigate within the vertebral body to target the spinal fracture with greater precision and control, while also sparing the bone - two unique benefits of RF-TVA over older, conventional therapies such as balloon kyphoplasty. The RF-TVA procedure typically takes 30-40 minutes to complete under local anesthesia. Patients report significant and lasting back pain relief, significant improvement in mobility and quality of life, and often return to daily activities soon after the procedure.3-5 Patients can go home the same day or the following day. RF-TVA is a safe, proven and effective procedure that presents low-risk and a significant benefit for the patient.* DFINE received 510(k) clearance and commercially introduced the StabiliT system in 2008. To date, more than 12,000 spinal fractures have been treated with StabiliT worldwide.
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 that presently covers two procedural applications. The first application, the StabiliT® Vertebral Augmentation System and StabiliT® ER2 Bone Cement, harnesses the power of radiofrequency energy to repair fractured vertebrae.* The company has received FDA 510(k) clearance for a second application, the STAR™ Ablation System, for the treatment of spinal tumors. The STAR system will be commercially available later this year. DFINE is based in San Jose, Calif. and is privately held. For more information visit www.dfineinc.com
* As with all medical treatment options, there are risks associated with the procedure. For a complete list of potential complications and to determine if you are candidate for RF-TVA, please consult a physician. Procedure results may vary from patient to patient.
1. “FY07 Annual VA Information Pamphlet (February 2008)". United States Department of Veterans Affairs. Retrieved 2009-06-
2. PearlDiver Patient Records Database, Nov. 2007: http://tinyurl.com/44qcmp8
3. Radiofrequency Kyphoplasty: A Novel Approach to Minimally Invasive Treatment of Vertebral Compression Fractures. Murphy K. In The Comprehensive Treatment of the Aging Spine: Minimally Invasive and Advanced Techniques edited by Yue, J.J., Guyer, R., Johnson, J.P., Khoo, L.T., Hochschuler, H., and Hochschuler, S.H., Elsevier. Pg 248-252.
4. Radiofrequency Kyphoplasty for the Treatment of Osteoporotic and Neoplastic Vertebral Body Fractures: Preliminary Experience and Clinical Results after 6 Months. Elgeti, F., and Gebauer, B., J Miner Stoffwechs 2011; 18 (Supplement 1).
5. One year observation study upon a new augmentation procedure (Radiofrequency-Kyphoplasty) in the treatment of vertebral body compression fractures. Licht A.W. and Kramer W. Eurospine 2011.