DFINE StabiliT® Vertebral Augmentation System Product Innovation Offers Physicians Improved Flexibility and Ease-of-Use for the Treatment of Spinal Fractures

SAN JOSE, Calif., May 24, 2011 /PRNewswire/ — DFINE, Inc., the developer of minimally invasive radio frequency (RF) targeted therapies for the treatment of vertebral pathologies, today announced two new product enhancements to its StabiliT® Vertebral Augmentation System – the most advanced treatment option for vertebral compression fractures (VCFs).

Designed to improve the physician experience and provide greater flexibility and ease-of-use for the minimally invasive treatment of VCFs, the product enhancements include:

• The VertecoR® Bone Drill 3.0 – The new VertecoR Bone Drill 3.0 features include a spade drill tip to aid the physician in docking the drill to the bone, as well as sharp, angled flutes for enhanced ease-of-use and precise channel creation in dense bone.  The 16.7-centimeter drill shaft is compatible with both short and long working cannulae, and shaft markings are provided for accurate depth measurement.

• StabiliT® First Fracture Kit – DFINE has adopted the use of blisterpack trays to allow consolidation of StabiliT System components into a single package. The kit now features a single tray for easy access to product components and a pre-filled cement syringe for a safer and more streamlined product set-up.

“DFINE is committed to helping patients affected by spinal pathologies by developing innovative, minimally invasive therapies to relieve pain and improve quality of life,” said Kevin Mosher, chief executive officer of DFINE. “Our StabiliT system and radio frequency targeted vertebral augmentation™ (RF-TVA), are a generational advance over conventional therapies – one that gives the physician unparalleled control and increased safety.  DFINE is dedicated to innovation and will continue to invest in the development of the platform in an effort to enhance the physician experience and improve patient outcomes.”

About StabiliT® and Radio Frequency 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.  StabiliT® ER2 Bone Cementfills 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 under local anesthesia to complete.  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.(1-6)  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.

About DFINE

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 radio frequency (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 radio frequency 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, call 1-866-963-3463 or 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 who is a candidate for RF-TVA with StabiliT, please consult a physician. Procedure results may vary from patient to patient.

REFERENCE:

1.  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.

2.  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).

3.  Radiofrequency kyphoplasty: a new method for the treatment of osteoporotic vertebral body compression fractures – a case report. Licht, A.W. and Kramer, W., J Miner Stoffwechs 2011; 18 (Supplement 1).

4.  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.

5.  Initial Clinical Experience with Radio-Frequency Based Vertebral Augmentation in Treatment of Vertebral Compression Fractures As a Result of Multiple Myeloma. Erdem E., Akdol S., Amole A., Fryar K., Eberle R. American Society of Spine Radiology 2011.

6.  Comparison of clinical and radiological data in treatment of patients with osteoporotic vertebral compression fractures with radiofrequency kyphoplasty or balloon kyphoplasty. Pflugmacher, R., Bornemann, R., Randau, T., and Wirtz, D.C.. GRIBOI 2011- The 21st Interdisciplinary Research Conference On Injectable  Osteoarticular Biomaterials and Bone Augmentation Procedures.

SOURCE DFINE, Inc.