LOR VERSION The next generation in the treatment of vertebral compression fractures Limitations of Current Generation of Products Products currently used to treat vertebral compression fractures (VCF’s), although used by many treating doctors, are not without limitations. They typically involve a bipedicular approach, involve a large cavity and/or a low viscosity cement. More invasive, bipedicular approach Potentially compromising valuable bone Current generation products involve bipedicular needle placement, potentially leading to more tissue trauma than a unipedicular approach. Balloon kyphoplasty may create oversized cavities, potentially causing unnecessary cancellous bone destruction and compromising long-term vertebral body stability. Limited interdigitation Uncontrolled cement delivery Oversized cavities with low viscosity cement may potentially prevent cement interdigitation. Many products involve a low viscosity bone cement that may result in a greater risk of extravasation. Radiation exposure Most products require physicians to deliver cement near the radiation source. The next generation in the treatment of vertebral compression fractures Cavity Creation Designed for Unipedular Access DFine StabiliT ® Navigational Osteotome for Site & Size Specific Cavity Extended Working Time** Distance from Radiation Source Yes Yes Yes 10 ft. Medtronic Kyphx No No No 0 ft.* Stryker iVas No No No 1.5 ft. Carefusion AVAmax No No No 1.5 ft. DePuy Confidence No No No 2.3 ft. ** When using a Bone Filler Device. ** Defined as ≥ 20 minutes at ≥ 20°C (data on file). RF Targeted Vertebral Augmentation (RF-TVA™) with the StabiliT® Vertebral Augmentation System Unparalleled Control Site and Size Specific Cavity Creation and Cement Delivery The VertecoR ® MidLine Osteotome features an articulating tip that curls up to 90 degrees. This allows site and size specific cavity creation via a unipedicular approach, potentially sparing valuable cancellous bone during the cavity creation process, and facilitating site specific cement delivery. VertecoR® MidLine Osteotome Unipedicular vertebral body access Minimizes bone destruction Creates a site and size specific cavity Ultra High Viscosity Cement StabiliT® ER2 Bone Cement is significantly more viscous than competitive bone cements, potentially decreasing the risk of cement extravasation. StabiliT® ER2 Bone Cement also has an extended working time. Viscosity (Pa*s) 6.000 5.000 StabiliT ® ER2 Ultra High Viscosity Range StabiliT® ER2 Bone Cement (with energy) 4.000 3.000 2.000 1.000 7 12 17 22 Time (min) 27 32 37 Interdigitation and Distribution Site and size specific cavity creation results in maintenance of cancellous bone into which StabiliT ® ER2 Bone Cement can interdigitate. Increased Safety Reduced Physician Radiation Exposure Using the Hand Switch Cable, physicians deliver cement at a controlled, constant rate from up to ten feet from the radiation source. 10' DFine Physician executes delivery up to 10 feet from patient side Low Radiation Exposure * 2.3' DePuy 0' Medtronic Physician executes delivery up to 2.3 feet from patient side High Radiation Exposure Physician executes delivery at patient side High Radiation Exposure 1.5' Stryker *When using a Bone Filler Device. Physician executes delivery up to 1.5 feet from patient side High Radiation Exposure Reduced Expense StabiliT® ER2 Bone Cement’s extended working time often allows physicians to treat multiple levels with a single fracture kit, resulting in hospital cost savings. Since the StabiliT ® System is available as a fully configured kit, purchasing ancillary products is not required, thus reducing total procedure cost. Using the StabiliT® System also results in reduced procedure time because it enables unipedicular vertebral body access. NOISREV RO Risks Statement As with most surgical procedures, serious adverse events, some of which can be fatal, can occur. Although RF-TVA™ is designed to minimize these risks as much as possible, potential serious adverse events that can occur include: • myocardial infarction (heart attack) • cardiac arrest (heart stops beating) • pulmonary embolism (cement leakage that migrates to the lungs) • paralysis or muscle weakness • cerebrovascular accident (stroke) • death A prescription is required. Please consult your physician for a discussion of these and other risks and if this procedure is right for you. Redefining the Treatment of Vertebral Pathologies 3047 Orchard Parkway, San Jose, CA 95134, USA • dfineinc.com • 866.96DFINE ©2010 DFine Inc. All rights reserved. PML2754-AB (06-2011)