Discover a new approach to vertebral augmentation

Transcription

1 Discover a new approach to vertebral augmentation AVAmax Advanced Vertebral Augmentation system The AVAmax vertebral balloon and AVAflex curved needle allowed a uniform cement fill during this pictured unipedicular T12 vertebral augmentation procedure. This result was comparable to the previous bipedicular result visible at L1, and the outcome of pain reduction was clinically similar. Vertebral augmentation performed using the AVAmax vertebral balloon and AVAflex curved needle AVAmax

2 AVAmax Advanced Vertebral Augmentation system No two patients or vertebral compression fractures (VCFs) are the same and they often require different treatment approaches. That is why CareFusion continues to expand your choices for performing vertebral augmentation with the AVAmax Advanced Vertebral Augmentation system. This new approach to vertebral augmentation allows you to customize your treatment approach to each one of your patients. The AVAmax system includes the most minimally invasive vertebral balloon available today and the unique AVAflex curved vertebral augmentation needle. The 11 G vertebral balloon fits through a cannula that is 19.8% smaller than the 10 G cannula. These innovative products allow you to successfully treat VCFs you may not have been able to treat in the past. AVAmax PLUS an easy-to-use system The AVAmax PLUS delivery system brings true innovation to bone cement preparation, injection and controlled cement placement. Automated cement mixing The AVAmax PLUS automated mixer mixes the cement inside the barrel for more consistent cement from procedure to procedure. AVAmax radiopaque bone cement long working time and excellent visibility The size of the barium sulfate particles in the AVAmax radiopaque bone cement creates a dual-imaging matrix, providing excellent radiopacity. This allows you to visualize cement flow and place cement under live imaging. It is also engineered to provide a long working time, which allows procedural flexibility, helping prevent the need to mix additional cement due to premature setting. The cement sets quickly once in the body. AVAmax 11 G vertebral balloon AVAflex curved needle

3 Consistent, controlled injections, and clean cannula removal The AVAmax PLUS system features a unique coaxial cement tube that extends through the cannula as a liner. Cement is delivered into the vertebral body from the very first turn because the coaxial cement tube is primed prior to insertion. For multiple-level procedures, the coaxial cement tube helps you easily and quickly switch injections from one cannula to another without leaving cement in the access cannula. The AVAmax PLUS system also offers these unique features: AVAmax vertebral augmentation drill The AVAmax drill features 10 mm markers that indicate how far the drill has traveled into the vertebral body, allowing approximately 36 mm of drill tip advancement beyond the end of the access cannula. Note: The markers on the drill should be used as reference marks only. They are not intended to replace the use of appropriate imaging technique. Use the appropriate imaging modality and technique to avoid penetrating the anterior cortex of the vertebral body. Reduced radiation exposure because the length of the AVAmax extension tube allows you to stand outside of the radiation beam Reduced odors and enhanced sharps safety with a fully enclosed glass monomer ampoule Preloaded components for bone cement preparation Ergonomic injector for comfortable operation with tactile control Drill tip 10 mm markers Cat. no. Description Qty. ea. Qty. cs. VMX00CT AVAmax PLUS procedure tray 1 5 VMXXLCT AVAmax PLUS extra level tray 1 5 AVAmax PLUS procedure tray components Coaxial cement tube, 11 G Coaxial cement tube, 13 G Injector handle Mallet Mixing barrel with radiopaque polymethylmethacrylate (PMMA) Mixing motor AVAmax vertebral augmentation drill Monomer in ampoule breaker Polyetheretherketone (PEEK) cement delivery tube Stainless steel forceps, 14 in. AVAmax PLUS extra level tray components Coaxial cement tube, 11 G Coaxial cement tube, 13 G Mixing barrel with radiopaque PMMA Vertebral augmentation drill Cat. no. Description Size Qty. ea. Qty. cs. AAK0008 Vertebral augmentation drill 8 G 1 5 AAK0010 Vertebral augmentation drill 10 G 1 5 AAK0011 Vertebral augmentation drill 11 G 1 5 Monomer in ampoule breaker PEEK cement delivery tube

4 AVAmax vertebral balloon Optimize visualization during procedure Each AVAmax vertebral balloon catheter contains a durable balloon that you fill with a contrast agent to aid visualization when you are creating a void in the vertebral body. Help ensure proper balloon placement The AVAmax balloon catheter features clearly defined marker bands on the shaft to help you properly advance and place the balloon while in the access cannula and in the vertebral body. Monitor pressure levels A digital pressure monitor is conveniently located at the tip of the inflation syringe to help you monitor pressure levels. At the touch of a button, you can choose to view the balloon pressure in either atmosphere or psi. AVAmax 11 G vertebral balloon today s most minimally invasive vertebral balloon The AVAmax 11 G vertebral balloon fits through an 11 G cannula that has a cross-sectional area 19.8% smaller than a 10 G cannula and 47.1% smaller than an 8 G cannula, yet it is just as effective as a 10 G or 8 G balloon, making it the most minimally invasive vertebral balloon on the market today. This allows you to perform kyphoplasty in areas where a larger balloon might prohibit the procedure. Size comparison Cannula cross-sectional area Actual cannula size 11 G cannula in 2 11 G 10 G cannula in 2 10 G 8 G cannula in 2 8 G Minimize waste Balloon access kits and inflation syringes are packaged single-sterile, minimizing waste and helping you improve operational efficiency. 11 G cannula is smaller than 10 G cannula by: 11 G cannula is smaller than 8 G cannula by: 19.8% 47.1% AVAmax 8 G and 10 G vertebral balloon The AVAmax 11 G vertebral balloon fits through an 11 G cannula and is the most minimally invasive balloon on the market today.

5 AVAmax vertebral balloon (continued) Adjustable coaxial cement tube The AVAmax vertebral balloon features a unique, adjustable coaxial cement tube that lines the access cannula while offering 0 to 27 mm of extension into the vertebral body. Primed prior to insertion, the coaxial cement tube enables cement delivery into the vertebral body from the anterior to the posterior wall using an adjustable locking connector. This connector can also be used to lock the coaxial cement tube in place. 1 2 AVAmax vertebral balloon procedure tray AVAmax vertebral balloons are available in 8 G, 10 G and 11 G sizes Cat. no. Description Size Qty. ea. Qty. cs. VBT0810 Vertebral balloon procedure tray 8 G 10 mm 1 5 VBT0815 Vertebral balloon procedure tray 8 G 15 mm 1 5 VBT0820 Vertebral balloon procedure tray 8 G 20 mm 1 5 VBT1010 Vertebral balloon procedure tray 10 G 10 mm 1 5 VBT1015 Vertebral balloon procedure tray 10 G 15 mm 1 5 VBT1020 Vertebral balloon procedure tray 10 G 20 mm 1 5 VBT1115 Vertebral balloon procedure tray 11 G 15 mm 1 5 VBT1120 Vertebral balloon procedure tray 11 G 20 mm 1 5 Adjustable coaxial cement tube is fully deployed within the vertebral body 3 4 Cement delivery started The AVAmax vertebral balloon procedure tray contains an inflation syringe, inflation valve, stopcock, 20 ml vacuum syringe, access cannula preloaded with a trocar-tip stylet, blunt stylet, bevel stylet, vertebral balloon and adjustable coaxial cement tube. As the cavity is filled, the adjustable coaxial cement tube is drawn back toward the posterior wall Desired fill is achieved

6 Clinical case: Balloon kyphoplasty for acute T8 compression fracture 11 G AVAmax vertebral balloon and AVAflex curved needle Background A 97-year-old osteoporotic female presented with a four-day history of progressively worsening atraumatic back pain. She refused to sit, walk or lie on her side due to the severity of her pain. She reported the pain at a level of 10/10. The MRI of the thoracic spine indicated a recent osteoporotic compression fracture at the T8 vertebral body. Procedure An 11 G access cannula was placed into the posterior one-third of the T8 vertebral body under fluoroscopic imaging, using a transpedicular approach from the patient s left. At this point, an 11 G AVAmax vertebral balloon was inserted and inflated, creating a cavity for cement deposition. Next, the AVAflex curved needle was inserted for targeted cement placement. Postprocedure imaging demonstrated PMMA distribution within the T8 vertebral body, opacifying the anterior two thirds with satisfactory midline crossage. Result Five hours following the procedure, the patient reported that the original pain symptoms had improved by 50%. The following morning, she reported complete pain resolution, regained her mobility and was discharged from the hospital. T8 osteoporotic compression fracture Access with vertebral balloon MRI demonstrating edema Targeted cement delivery with AVAflex curved needle Conclusion The new 11 G AVAmax vertebral balloon enabled a balloon kyphoplasty procedure to be performed at a higher level in the vertebral column, which in the past, has been limited to vertebroplasty. Study results reflect mean pain reduction at one week and two years as -6.1 and (VAS), respectively. Ledlie, J.,Renfro, M. Kyphoplasty treatment of vertebral fractures: Two-year outcomes show sustained benefits. SPINE, 2006, 31(1): Complete fill of superior end plate fracture

7 Flexibility The curved AVAflex needle can target areas that a straight cannula might not be able to reach. AVAflex curved needle The AVAflex curved vertebral augmentation needle is unique to the AVAmax system. The AVAflex needle is made from nitinol, a unique, super-elastic composite made from nickel and titanium. The ultra-flexible qualities of nitinol allow the curved AVAflex needle to target areas that a straight cannula might not be able to reach. Cat. no. Description Size Qty. ea. Qty. cs. AFH0011 AVAflex needle tray 11 G x 19 cm 1 5 The AVAflex needle tray contains an access cannula preloaded with a trocar-tip stylet, cannula probe, two depth guards, nitinol needle preloaded with a flexible stylet and swivel luer lock. Targeted cement placement The AVAflex needle allows targeted cement placement in the vertebral body and gives you maneuverability and flexibility unmatched by traditional straight cannulas. Flexible stylet The flexible stylet allows you to safely seal the needle aperture during cavity creation. Depth guards The depth guards allow you to determine how large a cavity you want to create. AVAflex needle tray

8 AVAmax handle/stylet kits Cat. no. Size Qty. ea. Qty. cs. VPH G x 12 cm 1 5 AVAmax handle/stylet kits The AVAmax system offers a variety of vertebral augmentation handles and stylets as well as a coaxial bone and vertebral body biopsy needle providing clinical flexibility and utility. VPH G x 12 cm 1 5 VPH G x 12 cm 1 5 VPH G x 12 cm 1 5 VPH G x 15 cm 1 5 Standard handle/stylet kit components Access cannula preloaded with trocar-tip stylet Bevel-tip stylet Cannula probe AVAmax coaxial bone and vertebral body biopsy needle kits Cat. no. Size Qty. ea. Qty. cs. JBC G x 12 cm access cannula 12 G x 15 cm * biopsy needle 1 5 JBC G x 12 cm access cannula 14 G x 15 cm * biopsy needle 1 5 JBC G x 12 cm access cannula 15.5 G x 15 cm * biopsy needle 1 5 * The length measured when the biopsy needle is inserted into the access cannula, which results in a 3 cm needle extension. Bone biopsy needle kit components Access cannula preloaded with trocar-tip stylet Biopsy needle 10 ml locking aspiration syringe Specimen retrieval probe AVAmax standard handle/stylet AVAmax biopsy needle kit

9 AVAprep patient prep kit The AVAprep patient prep kit contains components needed to prepare a patient for a vertebral augmentation procedure. AVAprep patient prep kit Cat. no. Description Qty. ea. Qty. cs. VPK9001 AVAprep patient prep kit 1 5 AVAprep kit components Bandages, 2 in. x 3 in. (2 ea.) Bupivacaine, 0.25%, 20 cc Custom patient drape Filter needles (2 ea.) Foam needle stick pad with adhesive backing Gauze pads, 4 in. x 4 in. (10 ea.) Isopropyl alcohol swab packet (3 sticks) Luer-lock syringes, 20 cc (2 ea.) OR towels (2 ea.) Plastic hub spinal needle, 20 G x 3½ in. Plastic hub spinal needle, 25 G x 3½ in. Point-Lok needle retention safety devices (4 ea.) Prevail-Fx PVP-I antimicrobial solution, with one-step applicator, 40 ml Safety hypodermic needle, 25 G x 1½ in. Safety scalpel, #11 Saline, 0.9%, 10 cc Table cover, 50 in. x 90 in. AVAprep patient prep kit

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12 For more information or to place an order, contact your Interventional Specialties sales representative at or visit carefusion.com/avamax. CareFusion Waukegan, IL carefusion.com 2013 CareFusion Corporation or one of its subsidiaries. All rights reserved. AVAflex, AVAmax, AVAprep, CareFusion and the CareFusion logo are trademarks or registered trademarks of CareFusion Corporation or one of its subsidiaries. All other trademarks are property of their respective owners. IS1165 (0413/2000)