SAN JOSE, Calif.–(BUSINESS WIRE)–DFine, Inc., a developer of minimally invasive solutions for treating vertebral compression fractures, announced today that it has launched a next generation access system for the RF Kyphoplasty procedure using the StabiliT® Vertebral Augmentation System.
“This is one of several key line extension products DFine intends to launch this year that will address unmet market segments and complete the RF Kyphoplasty product offering designed to treat vertebral compression fractures,” said Kevin Mosher, Chief Executive Officer of DFine Inc. “The new access system allows physicians the ability to treat a broader patient group and includes several advancements that aid in the function and placement of the devices.”
The new access system has been in limited release through the beginning of 2010 and has received positive feedback from physician customers. Dr Steven Smith, an Interventional Radiologist in Chicago, IL who has utilized the new access system on several occasions, commented, “This modified delivery system allows more accurate minimally invasive delivery of cement, and this means decreased trauma to the patient and potentially a more comfortable procedure.” Dr Ramsey Abadir in Middletown, NY, a physician also involved with the limited release of the product, said, “I see great advantages in utilizing the advance access system. The improved sharpness facilitates a highly accurate trajectory through the bone and the longer length improves access to all parts of the vertebral body. It is yet another reason why I choose to routinely perform RF Kyphoplasty.”
DFine will continue to bring new products to market in 2010 further strengthening its position as the technology leader in the treatment of vertebral compression fractures.
About Vertebral Compression Fractures:
There are approximately 750,000 vertebral compression fractures (VCFs) due to osteoporosis that occur in the US each year with only 1/3 being diagnosed by physicians.[1][2] Several studies have documented a decrease in mobility, patient quality of life and life expectancy due to osteoporotic vertebral compression fractures indicating it is a significant problem for elderly patients.[3][4][5] Economic studies have shown there are over 100,000 admissions due to VCFs in the US each year costing in excess of $500 Million/year in the United States alone.[6][7] As pain medication and bed rest can exacerbate the degree of bone loss and decrease patient mobility leading to other medical problems, the use of minimally invasive treatments like vertebroplasty and kyphoplasty have become increasingly common in the US and Europe to relieve pain, regain patient mobility and improve patient quality of life. [1][6]
About DFine
DFine, Inc., a privately held medical device company based in San Jose, Calif., is dedicated to advancing minimally invasive solutions for treating vertebral compression fractures and other spinal disorders to improve patient quality of life. DFine’s RF Kyphoplasty procedure with the StabiliT® Vertebral Augmentation System provides physicians greater control in the treatment of vertebral compression fractures through site and size specific cavity creation and an ultra high viscosity bone cement over an extended working time using a remotely controlled delivery system to stabilize the fracture, relieve pain and improve patient quality of life. For more information, visit www.dfineinc.com.
References
1. Melton L, Thamer M, Ray N et al. Fractures attributable to osteoporosis: report from the National Osteoporosis Foundation. J Bone Miner Res 12:16-23 1997
2. Papaioannou A, Watts N et al. Diagnosis and Management of Vertebral Fractures in Elderly Adults. Am J Med 113:220-228 2002
3. Gold D. The Clinical Impact of Vertebral Fractures: Quality of Life in Women with Osteoporosis. Bone 18:1855-1895 1996
4. Kado D, Browner W et al. Vertebral Fractures and Mortality in Older Women. Arch Inter Med 159:1215-1220 1999
5. Cauley, J Thompson D et al. Risk of Mortality Following Clinical Fractures. Osteoporosis International 11:556-561 2000
6. Gehlbach S, Burge T, et al. Hospital care of osteoporosis-related vertebral body fractures. Osteoporosis International 14:53-60; 2003
7. Riggs B, Melton L. The Worldwide Problem of Osteoporosis: Insights Afforded by Epidemiology. Bone 17:505S-511S 1995
