TORONTO, Oct. 15 /PRNewswire/ -- DFine, Inc., a developer of minimally invasive solutions for treating vertebral compression fractures (VCFs), today announced the launch of its StabiliT(TM) Vertebral Augmentation System and StabiliT(TM) ER Bone Cement at the 23rd annual meeting of the North American Spine Society (NASS). The StabiliT Vertebral Augmentation System allows for on-demand controlled delivery of a cohesive ultra-high viscosity cement in vertebral augmentation procedures (also known as vertebroplasty and kyphoplasty).
The DFine technology allows physicians to control the viscosity of the StabiliT ER Bone Cement, a proprietary energy responsive polymethylmethacrylate (PMMA) formulated cement, through the application of radiofrequency energy. The physician can change the bone cement viscosity on demand, delivering an ultra-high viscosity, yet flowable, cement that forms an internal cast for stabilizing the fracture. The process can yield height elevation of the collapsed vertebrae while minimizing leakage of bone cement (extravasation).
"The use of radiofrequency energy to give physicians the ability to control the viscosity of cement is novel and beneficial to both the physician and the patient," said Kieran J. Murphy, M.D., director of interventional neuroradiology at John Hopkins Hospital in Baltimore, Md. "The ability to minimize the leakage of bone cement is a large safety benefit I can present to my patients, providing them peace of mind in combination with much needed pain relief and improved quality of life."
The StabiliT Vertebral Augmentation System enables simultaneous cavity creation and filling. At the same time, the high viscosity of the cement may address the patient's fracture(s) with greater specificity through localized delivery of cement to compromised structures, providing a level of physician control of the cement that leads to optimized results for the patient.
One of the key benefits of DFine's products to physicians, as well as their hospitals, is the offering of a streamlined, cost-effective solution for vertebral augmentation. As well, DFine's innovative system allows the physician to perform a one-step procedure and makes a single percutaneous injection site possible. The ultra-high viscosity cement can be delivered over an extended period of time, which enables physicians to work on multiple vertebrae with one kit, potentially saving costs and improving efficiency.
"While the core of vertebral augmentation will always remain providing pain relief to the patient, we wanted to look outside the box for additional ways we could improve the procedure for both the patient and the physician," said Csaba Truckai, president and chief executive officer of DFine. "One of the greatest benefits we can offer to physicians is the potential to reduce physician radiation exposure."
More than 700,000 new VCFs occur every year in the United States due to osteoporosis, tumor growth and traumatic injury. In addition, there are an additional 440,000 osteoporotic-related fractures that go undiagnosed each year. Driven by a growing elderly population and increasing patient awareness, the minimally invasive VCF market is projected to grow by an annual rate of 14 percent until at least 2010.
Amid this rapid growth, there is the need to reduce the level of radiation exposure for physicians. DFine's remote hand switch allows optimized cement delivery from up to 10 feet away from the radiation source, while other vertebral augmentation procedures frequently bring the physician's hands very close (<24 inches) to the primary area of exposure.
DFine has been granted 510(k) clearance by the U.S. Food and Drug Administration to market the StabiliT Vertebral Augmentation System and StabiliT ER Bone Cement. To date, almost 50 spine specialists have used the StabiliT Vertebral Augmentation System and StabiliT ER Bone Cement in over 100 procedures.
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 quality of life. DFine's innovative system provides physicians with a precise means of delivering ultra-high viscosity bone cement to fractures of the spine in an effort to relieve pain and improve patient outcomes. The company's products include the StabiliT(TM) Vertebral Augmentation System and StabiliT(TM) ER Bone Cement, a proprietary energy responsive polymethylmethacrylate (PMMA) formulation. For more information, visit http://www.dfineinc.com.
CONTACT: Vanessa Hughes of Porter Novelli Life Sciences, +1-310-444-7019,
vanessa.hughes@porternovelli.com, for DFine, Inc.
Web site: http://www.dfineinc.com/