Advertisement
The DFine technology allows physicians to control the viscosity of theStabiliT ER Bone Cement, a proprietary energy responsivepolymethylmethacrylate (PMMA) formulated cement, through the application ofradiofrequency energy. The physician can change the bone cement viscosity ondemand, delivering an ultra-high viscosity, yet flowable, cement that forms aninternal cast for stabilizing the fracture. The process can yield heightelevation of the collapsed vertebrae while minimizing leakage of bone cement(extravasation).
Advertisement
"The use of radiofrequency energy to give physicians the ability tocontrol the viscosity of cement is novel and beneficial to both the physicianand the patient," said Kieran J. Murphy, M.D., director of interventionalneuroradiology at John Hopkins Hospital in Baltimore, Md. "The ability tominimize the leakage of bone cement is a large safety benefit I can present tomy patients, providing them peace of mind in combination with much needed painrelief and improved quality of life."
The StabiliT Vertebral Augmentation System enables simultaneous cavitycreation and filling. At the same time, the high viscosity of the cement mayaddress the patient's fracture(s) with greater specificity through localizeddelivery of cement to compromised structures, providing a level of physiciancontrol of the cement that leads to optimized results for the patient.
One of the key benefits of DFine's products to physicians, as well astheir hospitals, is the offering of a streamlined, cost-effective solution forvertebral augmentation. As well, DFine's innovative system allows thephysician to perform a one-step procedure and makes a single percutaneousinjection site possible. The ultra-high viscosity cement can be delivered overan extended period of time, which enables physicians to work on multiplevertebrae with one kit, potentially saving costs and improving efficiency.
"While the core of vertebral augmentation will always remain providingpain relief to the patient, we wanted to look outside the box for additionalways we could improve the procedure for both the patient and the physician,"said Csaba Truckai, president and chief executive officer of DFine. "One ofthe greatest benefits we can offer to physicians is the potential to reducephysician radiation exposure."
More than 700,000 new VCFs occur every year in the United States due toosteoporosis, tumor growth and traumatic injury. In addition, there are anadditional 440,000 osteoporotic-related fractures that go undiagnosed eachyear. Driven by a growing elderly population and increasing patient awareness,the minimally invasive VCF market is projected to grow by an annual rate of 14percent until at least 2010.
Amid this rapid growth, there is the need to reduce the level of radiationexposure for physicians. DFine's remote hand switch allows optimized cementdelivery from up to 10 feet away from the radiation source, while othervertebral augmentation procedures frequently bring the physician's hands veryclose (<24 inches) to the primary area of exposure.
DFine has been granted 510(k) clearance by the U.S. Food and DrugAdministration to market the StabiliT Vertebral Augmentation System andStabiliT ER Bone Cement. To date, almost 50 spine specialists have used theStabiliT Vertebral Augmentation System and StabiliT ER Bone Cement in over 100procedures.
About DFine
DFine, Inc., a privately held medical device company based in San Jose,Calif., is dedicated to advancing minimally invasive solutions for treatingvertebral compression fractures and other spinal disorders to improve qualityof life. DFine's innovative system provides physicians with a precise means ofdelivering ultra-high viscosity bone cement to fractures of the spine in aneffort to relieve pain and improve patient outcomes. The company's productsinclude the StabiliT(TM) Vertebral Augmentation System and StabiliT(TM) ERBone Cement, a proprietary energy responsive polymethylmethacrylate (PMMA)formulation. For more information, visit http://www.dfineinc.com.Media Contact: Vanessa Hughes Porter Novelli Life Sciences 310-444-7019 [email protected]
SOURCE DFine, Inc.
