AVAmax kyphoplasty brochure - CareFusion

A new approach 

to kyphoplasty 

AVAmax ® 

Advanced Vertebral 

Augmentation system 

The AVAmax ® vertebral balloon and AVAflex ® curved needle 

allowed a uniform cement fill during this unipedicular T12 

kyphoplasty procedure comparable to the previous bipedicular 

result visible at L1, and the outcome of pain reduction was 

clinically similar.

Discover the ease of the AVAmax PLUS 

advanced delivery system 

The AVAmax PLUS delivery system brings true innovation to bone cement 

preparation, injection and controlled cement placement. 

Automated cement mixing 

The AVAmax PLUS system’s automated mixer mixes the cement inside the 

barrel for more consistent cement from procedure to procedure. 

AVAmax Advanced Vertebral 

Augmentation system 

No two patients or vertebral compression fractures (VCFs) 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. This new approach to kyphoplasty allows you 

to customize your treatment approach to each of one your patients. 

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 once in the body so patient 

mobility is not compromised. 

The AVAmax system includes the most minimally invasive vertebral 

balloon available today and the unique AVAflex curved vertebral 

augmentation needle. These innovative products allow you to 

successfully treat VCFs that you may not have treated in the past.

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 

makes it easy and fast to switch injections from one cannula to another 

without leaving cement behind. 

The AVAmax PLUS system also offers these unique features: 

• Reduced radiation exposure because the length of the AVAmax extension 

tube allows clinicians to stand outside of the radiation beam 

• Reduced odors and enhanced sharps safety with fully enclosed glass 

monomer ampoule 

• Preloaded components for bone cement preparation 

• Ergonomic injector provides comfortable operation with tactile control 

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, 11G 


Injector handle 

Mallet 

Mixing barrel with radiopaque polymethylmethacrylate (PMMA) 

Mixing motor 

Monomer in ampoule breaker 

PEEK cement delivery tube 

Stainless steel forceps, 14” 

AVAmax PLUS extra level tray components 



Mixing barrel with radiopaque polymethylmethacrylate (PMMA) 

Monomer in ampoule breaker 

PEEK cement delivery tube

AVAmax vertebral balloon 

Optimize visualization during procedure 

Each AVAmax vertebral balloon catheter contains a durable balloon that is 

filled with a contrast agent to aid with visualization when creating a void in 

the vertebral body. 

Ensure proper balloon placement 

The AVAmax balloon catheter features clearly defined marker bands on 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. 

Minimize waste 

Balloon access kits and inflation syringes are packaged single-sterile, 

minimizing waste and improving operational efficiency. 

AVAmax 11G vertebral balloon—today’s most minimally invasive 

kyphoplasty balloon 

The AVAmax 11G vertebral balloon fits through a cannula that is 17% 

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 you 

to perform kyphoplasty in areas where a larger balloon might prohibit 

the procedure. 

Size comparison Outer diameter Cannula area Actual cannula size 

AVAmax 

11G cannula 

0.121 in 0.0115 in 2 11G 

KyphX 10G cannula 0.133 in 0.0139 in 2 10G 

CareFusion 11G 

cannula is smaller 

than Medtronic’s 

10G cannula by: 

9% 17.2% 

AVAmax 8G and 10G vertebral balloon 

The AVAmax 11G 

vertebral balloon is 

the most minimally 

invasive balloon on 

the market today.

AVAmax vertebral balloon (continued) 

AVAmax vertebral augmentation drill 

The AVAmax drill features 10mm markers that indicate how far the drill has 

traveled into the vertebral body, allowing for approximately 36mm 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. 

AVAmax vertebral balloon procedure tray 

Drill tip 

10mm 

markers 

AVAmax vertebral balloons are available in 8G, 10G and 11G sizes 

Cat. no. Description Size Qty. ea. Qty. cs. 

VBT0810 Vertebral balloon procedure tray 8G 10mm 1 5 








AVAmax vertebral augmentation drill 

Vertebral augmentation drill 

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, vertebral 

balloon and coaxial cement tube. 


AAK0008 Vertebral augmentation drill 8G 1 5 

AAK0010 Vertebral augmentation drill 10G 1 5 

AAK0011 Vertebral augmentation drill 11G 1 5

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 

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 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 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. 

Access with vertebral balloon 

Targeted cement delivery with 

AVAflex curved needle 

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. 

Complete fill of superior end plate fracture

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. 


AFH0011 AVAflex PLUS needle tray 11G x 19cm 1 5 

The AVAflex PLUS needle tray components consist of one access cannula 

preloaded with trocar-tip stylet, a cannula probe, a 10mm depth guard, a 

15mm depth guard, a nitinol needle preloaded with flexible stylet and a 

swivel luer lock. 

Cavity creation 

The AVAflex curved needle can 

also be used to assist in creating 

a cavity in the vertebral body 

prior to balloon insertion. 

Flexible stylet 

The flexible stylet 

allows you to safely 

seal the needle 

aperture during 

cavity creation. 

Depth guards 

The 10mm and 15mm 

depth guards allow you to 

determine how large a cavity 

you want to create.

AVAmax handle/stylet kits 

Cat. no. Size Qty. ea. Qty. cs. 

VPH0008 8G x 12cm 1 5 

AVAmax handle/stylet kits 

The AVAmax system offers a variety of vertebral augmentation cannulas, 

including a coaxial bone and vertebral body biopsy needle—providing 

clinical flexibility and utility. 

VPH0010 10G x 12cm 1 5 

VPH0011 11G x 12cm 1 5 

VPH0013 13G x 12cm 1 5 

VPH1511 11G x 15cm 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. 

JBC1210 

10G x 12cm access cannula 

12G x 15cm * biopsy needle 

1 5 

JBC1211 


14G x 15cm * biopsy needle 

1 5 

JBC1213 


15.5G x 15cm * biopsy needle 

1 5 

* Length measured when the biopsy needle is inserted into the access cannula, 

which results in a 3cm needle extension. 

Bone biopsy needle kit components 

Access cannula preloaded with stylet 

Biopsy needle 

10mL locking aspiration syringe 

Specimen retrieval probe 

AVAmax standard handle/stylet 

AVAmax biopsy needle kit

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˝ x 3˝ (2 ea.) 

Bupivacaine, 0.25%, 20cc 

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, 20cc (2 ea.) 

OR towels (2 ea.) 

Plastic hub spinal needle, 20G x 3 ½˝ 

Plastic hub spinal needle, 25G x 3 ½˝ 

Point-Lok needle retention safety devices (4 ea.) 

Prevail-Fx PVP-I antimicrobial solution, with one-step applicator, 40mL 

Safety hypodermic needle, 25G x 1 ½˝ 

Safety scalpel, #11 

Saline, 0.9%, 10cc 

Table cover, 50˝ x 90˝ 

AVAprep patient prep kit

For more information or to place an order, please contact 

your Interventional Specialties Sales Representative by 

calling 800.653.6827 or visit carefusion.com/avamax. 

CareFusion 

Waukegan, IL 

carefusion.com 

© 2011 CareFusion Corporation or one of its subsidiaries. All rights reserved. AVAflex, AVAmax and AVAprep are trademarks or registered 

trademarks of CareFusion Corporation or one of its subsidiaries. All other trademarks are property of their respective owners. IS2928 (1011/3000)

AVAmax kyphoplasty brochure - CareFusion

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