Vertebral augmentation procedure guide. AVAflex vertebral balloon system

Vertebral augmentation procedure guide AVAflex vertebral balloon system

Overview AVAflex vertebral balloon system No two patients or vertebral compression fractures are the same and they often require different treatment approaches. That s why CareFusion continues to expand your choices for performing vertebral augmentation with the AVAflex vertebral balloon system. This innovative system can be used for performing unipedicular balloon assisted vertebral augmentation by creating a cavity for targeted cement placement. Maximize your clinical value with a minimally invasive approach. Warning: Refer to the instructions for use for AVAflex vertebral balloon system, by CareFusion, for contraindications, warnings and cautions. Only qualified physicians with knowledge, experience and training in vertebral augmentation should use this product. The physician should have specific training and experience to be thoroughly familiar with the properties, handling characteristics, and application of the cement. The physician is responsible for any complication or harmful consequence, which may result from an erroneous indication or operating technique, from inappropriate use of the device, or nonobservation of the safety instructions that appear in the directions for use. Do not resterilize or reuse any components of this system for another patient. Table of contents Page AVAprep patient prep kit................... 3 AVAflex vertebral balloon.................. 4 5 AVAmax PLUS cement delivery system............6 7 AVAmax vertebral body bone drill............... 8 AVAmax coaxial bone and vertebral body biopsy needle....9 Vertebral augmentation Step 1 access cannula placement............ 10 Step 2 biopsy (if required)................ 11 Step 3 needle insertion and placement......... 12 Step 4 prepare balloon.................. 13 Step 5 balloon insertion................. 14 Step 6 balloon inflation................. 15 Step 7 mix the cement................ 16 17 Step 8 cement delivery................ 18 20 Notes............................. 21 Tray components..................... 22 23 It is the responsibility of the physician performing any procedure to determine the appropriateness of this product and specific technique for each patient. CareFusion, as a manufacturer, does not recommend surgical technique. 2

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

15 mm 20 mm 30 mm AVAflex vertebral balloon system The AVAflex vertebral balloon system is designed to be used with the AVAmax PLUS cement delivery system and other CareFusion vertebral augmentation products listed in this guide. AVAflex vertebral balloons are available in 15, 20 and 30-millimeter lengths, giving you choice and flexibility for your vertebral augmentation procedures. The AVAflex vertebral balloon system is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for kyphoplasty (for use with Radiopaque Bone Cement manufactured by CareFusion). Size (mm) Volume (ml) Diameter (mm) Length (mm) 15 2 11.8 13.8 15 4 17.7 17.4 20 2 9.8 19.8 20 4 16.1 21.1 20 6 19.2 23.8 30 2 7.1 29.8 30 4 12.4 31.3 30 6 15.7 33.1 30 8 17.8 35.1 The inflated dimensions* of each balloon may vary during product use due to local variation in bone structure. The maximum inflation pressure for each balloon size is 400 psi (pounds per square inch) or 27 atm (atmospheres). *Measured in Water at 98.6ºF/37ºC 4

2 5 11 6 9 1 3 4 8 7 10 Cat. no. Description Gauge size Balloon length Qty. ea Qty. cs AVAflex vertebral balloon tray includes: 1. Flexible vertebral balloon 2. Bevel stylet 3. Coaxial cement tube AFB1015 AFB1020 AVAflex vertebral balloon system with access cannula AVAflex vertebral balloon system with access cannula 10G 15 mm 1 5 10G 20 mm 1 5 Vertebral augmentation needle tray includes: AFB1030 AVAflex vertebral balloon system with access cannula 10G 30 mm 1 5 4. AVAflex vertebral augmentation needle with introducer 5. Access cannula with trocar-tip stylet 6. Swivel luer lock 7. Probe Vertebral balloon inflation syringe tray includes: 8. Inflation syringe 9. Stopcock 10. Inflation valve 11. Vacuum syringe 5

AVAmax PLUS cement delivery system The single use AVAmax PLUS system s automated mixer brings an enhanced level of cement consistency from procedure to procedure. Activation of the MIX button initiates an automated cycle that mixes the cement inside the mixing barrel, signaling when the mixing is finished. The AVAmax PLUS system features the exclusive AVAmax radiopaque bone cement. It has excellent radiopacity due to the size of the barium sulfate particles, which create a dual imaging matrix. This allows visualization of cement flow and placement under live imaging. 6

3 7 2 1 8 4 6 5 AVAmax PLUS cement delivery system components: 1. Injector handle 2. Mixing motor 3. PEEK extension tube 4. Coaxial cement tubes (11G and 13G) 5. Monomer in ampoule breaker 6. Mixing barrel pre-loaded with pre-opacified polymer 7. Mallet 8. Forceps Cat. no. Description Qty. ea Qty. cs VMX00CT AVAmax PLUS procedure tray 1 5 VMXXLCT AVAmax PLUS extra level tray (excluding mallet, forceps, mixer and handle) 1 5 7

AVAmax vertebral body bone drill The AVAmax advanced vertebral augmentation system provides physicians with instruments to create channels in the spinal bone structure prior to vertebral augmentation. Cat. no. Description Size Qty. ea Qty. cs AAK0008 Vertebral augmentation drill 8G 1 5 AAK0010 Vertebral augmentation drill 10G 1 5 AAK0011 Vertebral augmentation drill 11G 1 5 8

AVAmax coaxial bone and vertebral body biopsy needle This device is intended for use by a physician performing a bone or vertebral body biopsy using a coring, cutting, or aspiration technique. AVAmax coaxial bone and vertebral body biopsy needle tray components: 1. 10 ml locking aspiration syringe 2. Access cannula (pre-loaded with trocar-tip stylet) 3. Specimen removal probe 4. Coaxial biopsy needle* Cat. no. JBC1210 JBC1211 JBC1213 Description AVAmax coaxial bone and vertebral body biopsy needle AVAmax coaxial bone and vertebral body biopsy needle AVAmax coaxial bone and vertebral body biopsy needle Size 10G x 12 cm access cannula 12G x 19 cm biopsy needle 11G x 12 cm access cannula 14G x 19 cm biopsy needle 13G x 12 cm access cannula 15.5G x 19 cm biopsy needle * The biopsy needle extends outside of the access cannula by 3cm. Qty. ea Qty. cs 1 5 1 5 1 5 3 4 2 1 Franseen-type, triple-crown tip 9

Vertebral augmentation Step 1 access cannula placement To begin, place the patient in a prone position. Using sterile technique, prepare the needle insertion site. Infiltrate the skin and periosteum with local anesthetic according to clinical judgment. Use standard fluoroscopy procedures to locate the AVAmax access cannula. It is important to recognize the appropriate trajectory based on fracture type (A). Position the access cannula on the patient s skin surface with the aid of fluoroscopy (B/C). 1 The stylet tip placement should reflect the exact insertion point of the needle that will provide you an optimal angle to penetrate the vertebral body. Mark the lateral border of the pedicle. From the skin marking make an incision approximately 1 cm lateral (D). When advancing, the trajectory of the access cannula should project to the midpoint of the superior and inferior endplates to allow optimal balloon inflation, based on fracture type. For optimal, full deployment of the AVAflex Balloon, the access cannula should be placed in the lateral aspect (as opposed to a midline placement) of the vertebral body, remaining in the posterior third of the vertebra(e). Using clinically appropriate needle placement techniques, place access cannula. As needed, monitor placement of the access cannula periodically with fluoroscopy. 2,3,4,5,6,7 If you require a bone biopsy continue to step 2, otherwise go to step 3. 1 Warning: Procedures should only be performed in medical settings in which emergency equipment is available. 2 Warning: Throughout the procedure, use appropriate imaging techniques to verify correct placement of the access cannula and vertebral balloon and to assess the ability of the vertebral body to contain the inflated balloon. 3 Warning: For a transpedicular approach, if the pedicle is not large enough or stable enough to withstand the procedure, pedicle fracture may occur. 4 Warning: Complications that may occur during a parapedicular approach include pneumothorax and bleeding. 5 Warning: The physician should have specific training and experience to be thoroughly familiar with the properties, handling characteristics, and application of the cement. 6 Warning: The physician is responsible for any complication or harmful consequence, which may result from an erroneous indication or operating technique, from inappropriate use of the device, or nonobservation of the safety instructions that appear in the directions for use. 7 Warning: Do not resterilize or reuse any components of this system for another patient. A B D E C 10

Step 2 biopsy (if required) 1. Remove the trocar-tip stylet from the access cannula (A). 2. Insert the coaxial biopsy needle into the access cannula (B). 3. Advance the coaxial biopsy needle to the appropriate depth according to clinical judgment and the following visual indicators: When the most distal depth mark on the coaxial biopsy needle is even with the proximal surface of the access cannula luer hub, the distal tip of the coaxial biopsy needle is even with the distal tip of the access cannula (C). When the distal surface of the coaxial biopsy needle hub is in contact with the proximal surface of the access cannula luer hub, the distal tip of the coaxial biopsy needle extends approximately 3 cm beyond the distal tip of the access cannula. Caution: Use appropriate techniques to confirm the position of the access cannula and coaxial biopsy needle tips. Be aware of any anatomical considerations of this positioning. 4. After the appropriate depth has been reached, rotate the coaxial biopsy needle clockwise five (5) full revolutions and counterclockwise five (5) full revolutions (D). 5. Remove the coaxial biopsy needle from the access cannula. 6. Insert the specimen removal probe into the proximal end of the coaxial biopsy needle (E). Carefully eject the specimen from the distal end of the coaxial biopsy needle. The access cannula should be left in position for further procedures, if desired. Monitor the needle and access cannula placement periodically under fluoroscopy. A C D B Warning: Do not use for a sternal procedure. Due to the needle length, internal thoracic organs or blood vessels may be punctured or otherwise damaged. E 11

Step 3 AVAflex needle with introducer insertion and placement 1. While holding the access cannula in one hand and the curved section of the AVAflex needle with introducer in the other, begin inserting the AVAflex needle into the access cannula (A). A 2. Use appropriate imaging technique to determine when the distal tip of the AVAflex needle is near the access cannula tip (B). 3. Rotate the AVAflex needle with introducer until the directional indicators point in the desired direction (C). 4. While supporting the access cannula, push the AVAflex needle into the vertebral body to the desired position. Use the appropriate imaging technique to verify placement of the AVAflex needle (D). Note: To reposition the AVAflex needle, fully retract only the AVAflex needle from the access cannula, and then retract the introducer. Reassemble the introducer onto the AVAflex needle, ensuring the AVAflex needle and the introducer arrows are aligned. Repeat Step 3 AVAflex needle with introducer insertion and placement. B C 5. Once the AVAflex needle is in the desired location, hold the introducer and access cannula in place while slowly removing the AVAflex needle from the introducer (E). D Warning: Retracting the AVAflex needle and the introducer simultaneously may damage the introducer. E 12

Step 4 prepare balloon Prep AVAflex vertebral balloon system 1. Submerge the luer connector on the inflation syringe in a beaker of contrast agent to load the syringe (A). 1 Only inflate the balloon with liquid contrast medium. A 60% solution is recommended. Follow manufacturer s instructions for contrast medium indications, usage, and cautions. 2. Fill the syringe by engaging the quick-release bar on the inflation syringe handle, while pulling the handle back completely (B). 3. Hold the syringe upward, keeping the handle towards the floor (C). 4. Depress the quick release bar and push upward to purge air (D). Make note of the contrast fluid level within the inflation syringe. 5. Attach the inflation valve to the side port on the balloon catheter marked BALLOON (E). 6. Attach the 20 ml vacuum syringe to the inflation valve by pushing the tip into the inflation valve, turning clockwise (F). 7. Pull the vacuum syringe handle all the way back, twisting the handle to the right to lock it in the retracted position (G). This applies negative pressure to the balloon, which is necessary to remove air from the system. 8. Disconnect the vacuum syringe from the inflation valve (H). 9. Attach the luer connector on the inflation syringe to the inflation valve on the balloon by pushing it in and turning it clockwise (I). 10. Remove the balloon protector. A C E F B D G I 1 Warning: Never use air or any gaseous material to inflate the vertebral balloon. H 13

Step 5 - balloon insertion 1. Remove the balloon protector. While holding the introducer in place, insert the balloon through the introducer until the balloon shaft marker band is near the entrance of the introducer (A). 2. This indicates the balloon catheter tip is near the introducer tip (B/C). A Note: Do not unfold the balloon prior to insertion. 3. While maintaining the balloon position, fully retract the introducer towards the balloon Y-connector to fully expose the balloon within the vertebral body (D). 4. Monitor the final placement of the balloon using the appropriate imaging modality. Radiopaque markers provide for fluoroscopic visualization of the vertebral balloon prior to filling it with contrast fluid (E). B C D E 14

Step 6 - balloon inflation 5. Press the blue button to activate the digital pressure monitor. Press and hold the blue button for 4 seconds to toggle between displaying the balloon pressure in psi or atm (E). 6. Slowly turn the inflation syringe handle clockwise to inflate the balloon, infusing contrast fluid into the balloon in small increments (0.25-0.5 ml) (F). E 7. Monitor the balloon inflation using the appropriate imaging modality. Observe the display on the digital pressure monitor. Continue turning the handle until the balloon reaches desired cavity size (G). Lateral and axial fluoroscopic views of vertebral balloon inflation (H/I). Note: Do not exceed maximum inflation volume and/or pressure. 8. Engage the quick-release handle on the inflation syringe. Retract the handle to deflate the balloon. Confirm deflation using the appropriate imaging modality (J). Note: Never remove the vertebral balloon without fully deflating the balloon. F G Note: To create a larger void, see Instructions for Use contained in the product package for Balloon Double Inflation section. 9. Simultaneously remove the vertebral balloon and introducer from the access cannula with a gentle pulling/twisting motion. The cavity in the vertebral body is now ready for cement injection using a delivery system by CareFusion (K). Note: Do not withdraw the vertebral balloon against resistance or without the introducer. Determine the cause of resistance using imaging and take appropriate action. H J I K 15

Step 7 mix the cement Cement preparation using the AVAmax PLUS system: Refer to the instructions for use for Radiopaque Bone Cement, by CareFusion, for contraindications, warnings, cautions, and adverse reactions related to bone cement. Cement handling characteristics outlined in the instructions for use are based upon ASTM/ISO standards. A 1. Hold the cement barrel in a vertical position and remove cap #1 from the end of the barrel (A). 2. Keeping the barrel in a vertical position, rotate the threaded barrel into the injector handle (B). 3. Continue rotating the barrel until the raised indicator on the barrel aligns with the raised indicator on the face of the injector handle. (You may hear it click into its final position.) 4. Remove cap #2 from the end of the barrel. 5. Align the guide tabs on the barrel with the mixer (C). B 6. Gently push together and rotate the barrel 90 degrees clockwise until it locks into place. 7. Carefully level out the powder within the barrel. Caution: Break ampoule only when attached to barrel. 8. Remove cap #3 from the barrel. Gently thread the ampoule breaker clockwise onto the barrel, being careful not to turn the green handle at the top (D). 9. After the ampoule breaker is securely connected to the barrel, twist the green handle on the top of the syringe until it aligns with the finger tabs to break the ampoule. C It is best practice to tap the ampoule breaker so that there isn t a vapor block holding the monomer within the ampoule when draining it. 10. While tapping ampoule breaker, allow 7-10 seconds for liquid monomer to drain into lower reservoir. Slowly push the syringe plunger to inject the liquid monomer into the barrel. 11. Unthread the monomer syringe and replace the tethered #3 cap on the barrel. D 16

12. Remove the red safety tab from the mixing motor and press the MIX button (E). 13. While the motor is mixing the cement, an indicator light will flash. Mixer runtime is approximately 2 minutes 45 seconds. 14. When the mixing is completed, the indicator light will stop flashing and remain lit. 15. Disconnect the mixing motor by twisting it 90 degrees counterclockwise. E Prime system 1. Tap out any unmixed powder from the barrel tip. 2. Connect the PEEK tubing to the end of the barrel (F). 3. Point the barrel and PEEK tube downward. Begin rotating the injector handle clockwise until the front set of threads on the plunger disengage from the handle (G). 4. Slide the plunger forward and rotate until all air is purged and the second set of threads on the plunger handle are engaged (G). F 5. Turn the plunger clockwise to prime the PEEK tube. 6. Continue priming until about 1 cc of cement flows from the tip of the PEEK tube. 7. Rotate the plunger counterclockwise to relieve pressure on the PEEK tube. 8. Wipe any cement residue from the tip of the PEEK tube. G 17

Step 8 cement delivery Cement Injection using AVAflex Needle 1. Remove the flexible stylet from the AVAflex needle by rotating the cap 90 degrees and pulling straight up (A). 2. After preparing the cement delivery system, connect the system to the AVAflex needle. If desired, the swivel luer lock may be connected between the cement delivery system and the AVAflex needle to allow increased system movement during injection (B). 3. Purge cement through the AVAflex needle until physician desired cement characteristics are achieved. Disconnect the AVAflex needle from the cement delivery system for ease of use when inserting into the access cannula (C). 4. While holding the access cannula in one hand and the curved section of the AVAflex needle in the other, begin inserting the AVAflex needle into the access cannula (D). A B C D 18

5. Continue inserting the AVAflex needle into the access cannula. When the marker on the AVAflex needle enters the luer on the access cannula, the distal tip is near the access cannula exit (E). 6. Rotate the AVAflex needle until the directional indicators point in the desired direction (F). 7. Using the appropriate imaging modality to monitor the position of the distal tip, advance the AVAflex needle until the distal tip reaches the target injection site (G). 8. Connect the cement delivery system to the AVAflex needle. Inject Radiopaque Bone Cement, manufactured by CareFusion, using the appropriate injection technique (H). E F G H 19

Warning: If it is necessary to reposition the AVAflex needle to inject in another location, the AVAflex needle must be fully retracted into the access cannula before being redirected to a new position. 1. After injection is complete, disconnect the cement delivery system from the AVAflex needle. Slowly pull the AVAflex needle from the access cannula until it has been completely removed (I). 2. Then insert the trocar-tip stylet and remove the access cannula with stylet from the patient (J). 3. Fluoroscopic image of completed cement fill (K). I J K 20

Notes 21

Tray components AVAprep patient prep kit AVAflex vertebral balloon system Cat. no. Description Qty. ea Qty. cs VPK9001 AVAprep patient prep kit 1 5 Cat. no. Description Gauge size Balloon length Qty. ea Qty. ea AVAprep kit components Bandages, 2 x 3 (2 ea.) AFB1015 AVAflex vertebral balloon system with access cannula 10G 15 mm 1 5 Custom patient drape Filter needles (2 ea.) Foam needle stick pad with adhesive backing AFB1020 AVAflex vertebral balloon system with access cannula 10G 20 mm 1 5 Gauze pads, 4 x 4 (10 ea.) Isopropyl alcohol swab packet (3 sticks) AFB1030 AVAflex vertebral balloon system with access cannula 10G 30 mm 1 5 Luer-lock syringes, 20 cc (2 ea.) OR towels (2 ea.) Plastic hub spinal needle, 20G x 3½ Plastic hub spinal needle, 25G x 3½ Point-Lok needle retention safety devices (4 ea.) Prevail-Fx PVP-I antimicrobial solution, with one-step applicator, 40 ml Safety hypodermic needle, 25G x 1½ Safety scalpel, #11 Saline, 0.9%, 10 cc Table cover, 50 x 90 AVAflex vertebral balloon system kit contents Flexible vertebral balloon Bevel stylet Coaxial cement tube AVAflex vertebral augmentation needle with introducer Access cannula with trocar-tip stylet Swivel luer lock Probe Inflation syringe Vacuum syringe Stopcock Inflation valve 22

AVA max vertebral body bone drill Cat. no. Description Size AAK0008 Qty. ea Qty. cs Vertebral augmentation drill 8G 1 5 AVAmax PLUS system 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 AAK0010 AAK0011 Vertebral augmentation drill 10G 1 5 Vertebral augmentation drill 11G 1 5 Coaxial cement tube, 11G Coaxial cement tube, 13G Injector handle Mallet AVAmax coaxial bone and vertebral body biopsy needle Mixing barrel with radiopaque PMMA Mixing motor Cat. no. Description Size JBC1210 AVAmax coaxial bone and vertebral body biopsy needle 10G x 12 cm access cannula 12G x 19 cm biopsy needle Qty. ea Qty. cs 1 5 Monomer in ampoule breaker PEEK cement delivery tube Stainless steel forceps, 14 AVAmax PLUS extra level tray components Coaxial cement tube, 11G JBC1211 AVAmax coaxial bone and vertebral body biopsy needle 11G x 12 cm access cannula 14G x 19 cm biopsy needle 1 5 Coaxial cement tube, 13G Mixing barrel with radiopaque PMMA Monomer in ampoule breaker PEEK cement delivery tube JBC1213 AVAmax coaxial bone and vertebral body biopsy needle 13G x 12 cm access cannula 15.5G x 19 cm biopsy needle 1 5 AVAmax coaxial bone and vertebral body biopsy needle kit components 10 ml locking aspiration syringe Access cannula with trocar-tip stylet Specimen removal probe Coaxial biopsy needle 23

To place an order or for more information, please contact your Interventional Specialties sales representative, call Customer Service at 800.323.9088 or visit carefusion.com/avamax. CareFusion Vernon Hills, IL carefusion.com 2015 CareFusion Corporation or one of its subsidiaries. All rights reserved. AVAmax, AVAtex, AVAprep, AVAflex, Prevail-Fx, 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. IS4877 (0615/1000)