Newly Availabe, Newly Approved
Vertebral Augmentation System and ER Bone Cement
| DFine, Inc., a developer of minimally invasive solutions for treating vertebral compression fractures (VCFs), announced the launch of its StabiliT™ Vertebral Augmentation System and StabiliT™ ER Bone Cement. The StabiliT Vertebral Augmentation System allows for on-demand controlled delivery of a cohesive ultra-high viscosity cement in vertebral augmentation procedures.
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 StabiliT Vertebral Augmentation System enables simultaneous cavity creation and filling. The company notes that the high viscosity of the cement may address the patient’s fracture with greater specificity through localized delivery of cement to compromised structures.
DFine observes that its streamlined, cost-effective solution for vertebral augmentation 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.
For more information, contact DFine, Inc.,
DFine, Inc.
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Demineralized Bone Matrix
| Integra LifeSciences Holdings Corporation announced it has received 510(k) clearance from the US Food and Drug Administration to market Accell Evo3™ in the United States.
Accell Evo3™ is the latest generation in demineralized bone matrix and is composed of an optimized blend of particulate Demineralized Bone Matrix (DBM), the proprietary Accell® Bone Matrix (ABM), and a unique poloxamer Reverse Phase Medium. The poloxamer Reverse Phase Medium is a thermo-reversible carrier that thickens at body temperature and is more flowable at room temperature.
Accell Evo3™ contains more of the patented Accell® Bone Matrix than Integra’s previous generation Accell® products. The company notes that the optimized platform of Accell Evo3™ enables the bone healing process to take advantage of the naturally available bone proteins found in DBM and ABM. Accell Evo3™ has been specifically formulated to provide surgeons with the best possible intraoperative handling characteristics for proper utilization of the graft material and is marketed in combination with a new custom-designed open-bore syringe.
Integra notes that Accell Evo3™ may be used as a bone graft extender in the spine, extremities, and pelvis or as a bone void filler for the extremities and pelvis and may replace the need to harvest bone graft material from the iliac crest, thus sparing the |