AVAmax Advanced Vertebral Augmentation system A 21st century approach to vertebral augmentation
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®
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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 AVAmax Advanced Vertebral Augmentation system. ®
AVAmax PLUS delivery system
This innovative system now includes the tools you need to perform kyphoplasty or vertebroplasty—and choose the right approach at the point of care. A 21st century approach to vertebral augmentation.
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Offering flexibility and choice for you and your patients.
Discover the ease of the AVAmax PLUS advanced delivery system This innovative solution gives you the freedom to perform kyphoplasty or vertebroplasty using the same delivery system, optimizing your workflow. There’s no need to learn or manage different systems—just one advanced system that’s incredibly easy to use. The AVAmax PLUS Advanced Vertebral Augmentation system brings true innovation to bone cement preparation, injection
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and controlled cement placement.
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Automated cement mixing The AVAmax PLUS system’s automated mixer mixes the cement inside the mixing barrel for more consistent
AVAmax radiopaque bone cement—long working time, excellent visibility AVAmax radiopaque bone cement has excellent radiopacity because of the size of the barium sulfate particles, creating a dual-imaging matrix. This allows for visualization of cement flow and placement under live imaging. It is also engineered to have a long working time, which allows for procedural flexibility, helping users avoid the need to mix additional cement due to premature setting. The cement sets quickly
AVAmax PLUS delivery system
once in the body so patient mobility is not compromised.
Consistent, controlled injections and clean cannula removal This 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. If the procedure requires multiple injections, the coaxial cement tube makes it easy and fast to switch injections from one cannula to another without leaving cement in the cannula.
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cement from procedure to procedure.
Reduced radiation exposure The long length on the AVAmax extension tube allows clinicians to stand outside of the radiation beam.
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Reduced odors and enhanced sharps safety A fully enclosed glass monomer ampoule helps reduce exposure to fumes and sharps.
Preloaded components for bone cement preparation Cement is prepared directly in the barrel with preloaded radiopaque PMMA powder.
Rapid air purging for cement priming Two-stage threaded plunger on the injector provides rapid air purging for cement priming at the start of the procedure.
Comfortable operation with tactile control Ergonomically designed injector provides tactile feedback.
One flexible delivery system for both vertebroplasty and kyphoplasty 5
Your choice of delivery systems. If you’re looking for a more traditional delivery system and don’t need the automated mixing function, CareFusion also offers the standard AVAmax delivery system. It uses the same bone cement and coaxial tube as the advanced system, but
Cat. no.
Description
Qty. ea
Qty. cs
VMX00CT
AVAmax PLUS procedure tray
1
5
VMXXLCT
AVAmax PLUS extra level tray
1
5
BCT00CT
AVAmax procedure tray
1
5
BCTXLCT
AVAmax extra level tray
1
5
AVT00BT
AVAtex delivery system
1
5
BCPM003
AVAtex radiopaque bone cement
1
5
®
AVAmax PLUS procedure tray
®
AVAmax PLUS delivery system
AVAprep patient prep kit The AVAprep patient prep kit contains components needed to prepare a patient for a vertebroplasty or a kyphoplasty procedure. For use with any vertebral augmentation system.
Cat. no.
Description
VPK9001
AVAprep patient prep kit
Qty. ea
Qty. cs
1
5
AVAprep patient prep kit
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allows you to mix the cement yourself.
Vertebroplasty Your choice of cannulas. The AVAmax system offers three types of traditional access for vertebroplasty, including a coaxial bone and vertebral
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body biopsy needle—providing clinical flexibility and utility.
AVAmax standard handle/stylet kits feature: • Low-profile access cannula preloaded with a sharp, trocar-tip stylet for cortical penetration • Bevel-tip stylet to facilitate redirection • Tapered cannula to provide a smooth transition from stylet tip to outer cannula • Radiolucent design • Probe for clearing the cannula
Sharp trocar tip
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AVAmax match-ground bevel handle/stylet kits feature: • Low-profile access cannula preloaded with a sharp, bevel-tip stylet
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to facilitate cortical penetration and tip redirection • Match-ground cannula to provide a seamless transition from stylet tip to outer cannula • Radiolucent design
Vertebroplasty
• Probe for clearing the cannula
Match-ground bevel tip
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AVAmax coaxial bone and vertebral body biopsy needles feature: • Franseen-type, triple-crown tip to facilitate advancement and specimen sampling, allowing for full core retention without compromise • Centimeter depth markings to indicate the distal tip exposure
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and assist in sample size verification • Needle length that provides up to a 3 cm extension beyond the distal tip of the cannula • Low-profile, transparent luer-lock hub • 10 mL locking aspiration syringe that creates negative pressure, helping to retain the core sample • Blunt-tip probe to aid in core sample removal
Franseen-type, triple-crown tip
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Kits include: • Each handle/stylet kit includes one access cannula (preloaded with stylet) and one cannula probe • The standard handle kits also include a bevel-tip stylet • The bone biopsy needle kits also contain one biopsy needle, a 10 mL
Cat. no.
Description
Size
Qty. ea
Qty. cs
VPH0008
AVAmax standard handle/stylet kit
8G x 12 cm
1
5
VPH0010
AVAmax standard handle/stylet kit
10G x 12 cm
1
5
VPH0011
AVAmax standard handle/stylet kit
11G x 12 cm
1
5
VPH0013
AVAmax standard handle/stylet kit
13G x 12 cm
1
5
VPH1511
AVAmax standard handle/stylet kit
11G x 15 cm
1
5
VPH0011B
AVAmax match ground bevel handle/stylet kit
11G x 12 cm
1
5
VPH0013B
AVAmax match ground bevel handle/stylet kit
13G x 12 cm
1
5
JBC1210
AVAmax coaxial bone and vertebral body biopsy needle access cannula
10G x 12 cm access cannula
1
5
AVAmax coaxial bone and vertebral body biopsy needle access cannula
11G x 12 cm access cannula
1
5
AVAmax coaxial bone and vertebral body biopsy needle
13G x 12 cm access cannula
1
5
JBC1213
12G x 15 cm* biopsy needle
Vertebroplasty
JBC1211
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locking aspiration syringe and one specimen retrieval probe.
14G x 15 cm* biopsy needle
15.5G x 15 cm* biopsy needle
*Length measured when the biopsy needle is inserted into the access cannula, which results in a 3 cm needle extension.
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Kyphoplasty AVAmax vertebral balloons Optimize visualization during procedure Each AVAmax vertebral balloon catheter contains a durable balloon
AVAmax 11G vertebral balloon—today’s most minimally invasive kyphoplasty balloon
that is filled with a contrast agent to aid with visualization when
The AVAmax 11G vertebral balloon fits through a cannula that is 17%
creating a void in the vertebral body.
smaller than a 10G cannula, yet it is just as effective, making it the most minimally invasive vertebral balloon on the market today. This allows
Ensure proper balloon placement The AVAmax balloon catheter features clearly defined marker bands on
you to perform kyphoplasty in areas where a larger balloon might prohibit the procedure.
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the shaft to help you identify proper advancement and placement of 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 Atmospheres or PSI.
Size comparison
Outer diameter
Cannula area
AVAmax 11G cannula
0.121 in
0.0115 in2
KyphX 10G cannula
0.133 in
0.0139 in2
9%
17.2%
CareFusion 11G cannula is smaller than Medtronic’s 10G cannula by:
Minimize waste Balloon access kits and inflation syringes are packaged single-sterile, minimizing waste and improving operational efficiency.
AVAmax 8G and 10G vertebral balloon
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The AVAmax 11G vertebral balloon is the most minimally invasive balloon on the market today.
Actual cannula size
11G 10G
AVAmax vertebral balloon procedure tray The AVAmax vertebral balloon procedure tray contains an inflation syringe, an inflation valve, a stopcock, a 20mL vacuum syringe, an access cannula preloaded with trocar-tip stylet, a blunt stylet, a bevel stylet,
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vertebral balloon and coaxial cement tube.
Cat. no.
Description
Balloon size
Qty. ea
Qty. cs
VBT0810
Vertebral balloon procedure tray 8G
10 mm
1
5
VBT0815
Vertebral balloon procedure tray 8G
15 mm
1
5
VBT0820
Vertebral balloon procedure tray 8G
20 mm
1
5
VBT1010
Vertebral balloon procedure tray 10G
10 mm
1
5
VBT1015
Vertebral balloon procedure tray 10G
15 mm
1
5
VBT1020
Vertebral balloon procedure tray 10G
20 mm
1
5
VBT1115
Vertebral balloon procedure tray 11G
15 mm
1
5
VBT1120
Vertebral balloon procedure tray 11G
20 mm
1
5
Kyphoplasty
The AVAmax vertebral balloon inflation syringe features a digital pressure monitor that shows balloon pressure in either Atmospheres or PSI.
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Clinical case: Balloon kyphoplasty for acute T8 compression fracture 11G 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. Patient refused to sit, walk or lay on her side due to the severity of her pain. Pain was reported as 10/10. MRI of the thoracic spine indicated a recent osteoporotic compression
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fracture at the T8 vertebral body. Procedure An 11G 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 11G AVAmax vertebral balloon was inserted, then inflated, creating a cavity for cement deposition. Next, the AVAflex curved needle was inserted for targeted cement placement. Post procedure imaging demonstrated polymethylmethacrylate (PMMA) cement distribution within the T8 vertebral body, opacifying the anterior two-thirds
Access with vertebral balloon
with satisfactory midline crossage. Result Five hours following the procedure, the patient reported a 50% improvement of original pain symptoms. The following morning the patient’s pain had completely resolved, she regained her mobility and she was discharged from the hospital. Conclusion The new 11G AVAmax vertebral balloon enabled a balloon kyphoplasty procedure to be performed at a higher level in the vertebral column which, in the past, has traditionally been limited to vertebroplasty.
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Complete fill of superior endplate fracture
Targeted cement delivery with AVAflex curved needle
AVAmax vertebral augmentation drill AVAmax Advanced Vertebral Augmentation system Part of the AVAmax system, the new AVAmax vertebral augmentation drill is intended to be used with an AVAmax access cannula to create channels in spinal bone structure prior to a vertebroplasty
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or kyphoplasty procedure.
Markers Markers on the drill indicate how far the drill has traveled into the vertebral body. The markers are located 10 mm apart, allowing for 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.
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
Kyphoplasty
10G drill
Drill tip
10 mm markers
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A unique approach— AVAflex curved vertebral augmentation needle. ®
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The flexible choice.
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.
Targeted cement placement The AVAflex curved needle allows for targeted cement placement in the vertebral body. The AVAflex needle gives clinicians maneuverability and flexibility unmatched by traditional straight cannulas.
Cavity creation The AVAflex curved needle can also be used to assist in creating a cavity in the vertebral body.
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AVAflex PLUS curved vertebral augmentation needle The AVAflex PLUS needle tray includes a nitinol needle (preloaded with flexible stylet), access cannula (preloaded with trocar-tip stylet), cannula probe, swivel luer lock and 10 mm and 15 mm depth guards. The AVAflex curved injection needle kit includes a nitinol needle, an access cannula (preloaded with trocar-tip stylet), cannula probe and swivel luer lock. Cat. no.
Description
Size
Qty. ea.
Qty. cs.
AFH0011
AVAflex PLUS needle tray
11G x 19 cm
1
5
BCK9811
AVAflex needle kit
11G x 19 cm
1
5 Cavity creation with the AVAflex PLUS needle
Components for cavity creation
Depth guards
Flexible stylet
The 10 mm and 15 mm depth guards
The flexible stylet allows
allow you to determine how large a
you to safely seal the
cavity you want to create.
needle aperture during
A unique approach
cavity creation.
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Clinical case: Unipedicular kyphoplasty and targeted cement placement for T-12 fracture AVAmax vertebral balloon and AVAflex vertebral augmentation needle Background An 82-year-old female patient with a history of osteoporosis presented with severe back pain over the prior six to eight weeks. Subsequent MRI demonstrated superior endplate fracture of the T-12 vertebral body. Procedure Unipedicular access was achieved under biplanar fluoroscopy and a biopsy performed. Kyphoplasty was then performed using an AVAmax vertebral balloon to create a void in the vertebral body. Targeted cement delivery was then performed using an AVAflex curved needle. four ccs of PMMA were delivered into the superior endplate fracture lines and the anterior portion of the vertebral body. Result Patient tolerated the 20-minute procedure without complication. Resulting imaging demonstrated complete fill of the superior endplate fracture, as well as interdigitation of cement throughout the vertebral body, providing
Access with vertebral balloon
Targeted cement delivery with AVAflex curved needle
structural support. No cement extravasation was observed. Immediate pain relief was reported by the patient. Conclusion The AVAflex needle used in combination with the AVAmax vertebral balloon allowed for a unipedicular approach with targeted cement placement. The procedure was performed on an outpatient basis at a cost lower than the general cost of traditional kyphoplasty.
Complete fill of superior endplate fracture
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AVAmax system Cat. no.
Description
Qty. ea
Qty. cs
BCT00CT
AVAmax procedure tray
1
5
BCTXLCT
AVAmax extra level tray
1
5
AVAmax procedure tray components
Tray components
Ampoule disposal vial Cement barrel Injector handle Coaxial cement tube, 11G Coaxial cement tube, 13G Funnel Mallet
AVAmax PLUS system
Mixing vial 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, 11G Coaxial cement tube, 13G Injector handle Mallet Mixing barrel with radiopaque PMMA Mixing motor Monomer in ampoule breaker
Monomer disbursement cannula PEEK cement delivery tube Radiopaque bone cement Seal-less syringe, 20 cc Spatula Stainless steel forceps, 14˝ AVAmax extra level tray components Ampoule disposal vial Cement barrel Coaxial cement tube, 11G
PEEK cement delivery tube
Coaxial cement tube, 13G
Stainless steel forceps, 14˝
Funnel
AVAmax PLUS extra level tray components
Mixing vial
Coaxial cement tube, 11G
Monomer disbursement cannula
Coaxial cement tube, 13G
PEEK cement delivery tube
Mixing barrel with radiopaque PMMA
Radiopaque bone cement
Monomer in ampoule breaker
Seal-less syringe, 20 cc
PEEK cement delivery tube
Spatula
Ordering information
Cat. no.
18
AVAtex radiopaque bone cement
AVA-tex system Cat. no.
Description
AVT00BT
AVAtex delivery system
Qty. ea
Qty. cs
1
5
Cat. no.
Description
BCPM003
AVAtex radiopaque bone cement
AVAtex procedure tray components
AVAtex radiopaque bone cement components
• Cement barrel
Ampoule disposal vial
• Injector handle
Funnel
• PEEK cement delivery tube
Mixing vial
Qty. ea
Qty. cs
1
5
Monomer disbursement cannula AVAprep patient prep kit Cat. no.
Description
VPK9001
AVAprep patient prep kit
Radiopaque bone cement Qty. ea
Qty. cs
1
5
Seal-less syringe, 20 cc
AVAprep kit components
AVAflex curved vertebral augmentation needle kit
Bandages, 2˝ x 3˝ (2 ea.)
Cat. no.
Description
Bupivacaine, 0.25%, 20 cc
BCK9811
AVAflex needle kit
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, 20G x 3 ½˝ Plastic hub spinal needle, 25G x 3 ½˝ ®
Qty. cs
1
5
Qty. ea
Qty. cs
1
5
AVAflex needle kit components Access cannula (preloaded with trocar-tip stylet) Cannula probe Nitinol needle Swivel luer lock
AVAflex PLUS curved vertebral augmentation needle tray Cat. no.
Description
AFH0011
AVAflex PLUS needle tray
AVAflex PLUS needle tray components
Point-Lok needle retention safety devices (4 ea.)
Access cannula (preloaded with trocar-tip stylet)
Prevail-Fx® PVP-I antimicrobial solution, with one-step applicator, 40 mL
Cannula probe
Safety hypodermic needle, 25G x 1 ½˝
Depth guard, 10 mm
Safety scalpel, #11
Depth guard, 15 mm
Saline, 0.9%, 10 cc
Nitinol needle (preloaded with flexible stylet)
Table cover, 50˝ x 90˝
Swivel luer lock
19
Qty. ea
Specifications for 8G and 10G balloons
AVAmax vertebral balloon trays
Cat. no. VBT0810
VBT0815
Description Vertebral balloon procedure tray
Needle size 8G
Balloon size 10 mm
1
5
8G
Vertebral balloon procedure tray
8G
Vertebral balloon procedure tray
10G
VBT1015
Vertebral balloon procedure tray
10G
15 mm
1
5
VBT1020
Vertebral balloon procedure tray
10G
20 mm
1
5
VBT1010
VBT1115
VBT1120
20 mm
1
Qty. cs
Vertebral balloon procedure tray
VBT0820
15 mm
Qty. ea
1
5
5
Size (mm)
Volume (mL)
Diameter inflated (mm)
Length (mm)
10
2
12.8
11.7
18.3
16.3
11.8
14.9
17.5
18.4
10.0
19.6
16.2
20.9
19.1
23.4
10
4
15
2
15
4
20
2
20
4
20 10 mm
1
5
11G
Vertebral balloon procedure tray
11G
15 mm
20 mm
The AVAmax vertebral balloon procedure tray includes
1
1
*
*
Maximum inflation pressure = 400 PSI *
Vertebral balloon procedure tray
6
*
At maximum inflation volume
Specifications for 11G balloon
5
5
Size (mm)
Volume (mL)
Diameter inflated (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
Maximum inflation pressure = 400 PSI *
At maximum inflation volume
One inflation syringe • Inflation valve
Ordering information
• Stopcock • Vacuum syringe, 20 mL One vertebral balloon access kit • Access cannula (preloaded with trocar-tip stylet) • Bevel stylet • Blunt stylet • Coaxial cement tube • Vertebral balloon AVAmax 10G vertebral balloon
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21
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To place an order or for more information, please contact your Interventional Specialties Sales Representative, call Customer Service at 800.653.6827 or visit carefusion.com/avamax. © 2011 CareFusion Corporation or one of its subsidiaries. All rights reserved. AVAmax, AVAtex, AVAprep and AVAflex are trademarks or registered trademarks of CareFusion Corporation or one of its subsidiaries. All other trademarks are property of their respective owners. IS0066-03 (1011/2000)
CareFusion Waukegan, IL
carefusion.com
