KYPHON ASSIST™ Directional Cannula for Balloon Kyphoplasty 

The Kyphon Assist™ directional cannula provides more predictable inflation and direction of cavity creation during balloon kyphoplasty surgery for vertebral compression fractures.

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Overview

GET TO KNOW  KYPHON ASSIST™

Watch the video introduction to the Kyphon Assist™ directional cannula. 

KEY BENEFITS

MORE CONTROL AND MORE HEIGHT

When compared to standard access cannulas,1 the Kyphon Assist™ can redirect 76% of the inflatable bone tamp volume and increase the directional height by 37% for more height restoration potential.  

Kyphon Assist directional cannula tip used to insert the kyphoplasty balloon into the spine.

MORE FLEXIBILITY AND MORE CONFIDENCE

The Kyphon Assist™ can be used with any size of inflatable bone tamp allowing flexibility for procedural goals and anatomic considerations.  It comes in the familiar One-Step™ Xpander™ access and can be exchanged as needed for more accurate balloon placement.

The Kyphon Assist™ also provides the ability to inflate away from the lateral walls and endplate defects providing more control and confidence in balloon kyphoplasty procedures.

Kyphon Assist directional cannulas used at the same time during a balloon kyphoplasty procedure.

KEY BENEFITS

Study Results

A recent study2 of nondirectional balloon technique (n=51) and VCF patients treated with directional balloon technique (n=49) demonstrated the following outcomes for patients treated with a directional balloon technique:

  • Significantly immediate and sustained kyphotic angle correction post-surgery
  • Significantly early and immediate outcome improvement: The improvement in VAS, ODI, and RMD scores is significantly better than nondirectional technique at 3 days.
Chart comparing kyphotic correction over time between directional and nondirectional balloon technique. Data indicates that patients treated with directional balloon technique saw significantly immediate and sustained kyphotic angle correction post-surgery.

COMPARISON OF THE CLINICAL OUTCOMES RESULTS BETWEEN 2 GROUPS BEFORE AND AFTER OPERATION

 

 

Preoperative  

3 days  

1 month  

3 months  

6 months  

12 months  

VAS  

 

Group 1  

8.1 ± 1.2  

4.5 ± 1.3*†  

2.4 ± 1.2*  

2.1 ± 1.1*  

1.9 ± 1.0*  

2.3 ± 1.2* 

Group 2  

8.0 ± 1.1  

4.0 ± 1.1*  

2.2 ± 1.0*  

2.0 ± 1.0* 

1.8 ± 0.9*  

2.4 ± 1.3*  

ODI  

 

Group 1  

48.1 ± 2.2  

42.8 ± 3.2*† 

32.5 ± 2.2*  

25.4 ± 2.3* 

20.3 ± 2.1* 

18.8 ± 1.6*  

Group 2  

48.4 ± 1.9  

34.2 ± 2.4*  

30.4 ± 1.99*  

24.3 ± 2.1*  

20.1 ± 1.9* 

18.6 ± 1.3*  

RMD  

 

Group 1  

21.5 ± 1.8  

12.3 ± 1.3*†  

7.2 ± 2.1* 

6.9 ± 2.5*  

5.7 ± 2.3*  

7.1 ± 2.0*  

Group 2  

12.0 ± 1.7  

11.5 ± 1.2*  

6.7 ± 2.2*  

6.3 ± 2.3*  

5.5 ± 2.1*  

6.6 ± 1.9*  

Data were presented as mean ± standard deviation. ODI = Oswestry Disability IndexRMD = Roland Morris Disability QuestionnaireVAS = Visual Analogue Scale. 

 
  • Significantly reduced cement extravasation rate: The directional balloon technique reduced cement extravasation by 65% compared to conventional balloon kyphoplasty.
  • Significantly shortened operative and exposure time:
    • The directional balloon technique reduced operation time by 8% when compared to conventional balloon kyphoplasty.
    • The directional balloon technique reduced X-ray exposure by 20% when compared to conventional balloon kyphoplasty.

Group 1 
Conventional BKP
Group 2 
Directional BKP
P 

Case (N) 

51 

49

Operation time (min.)

47.8 ± 6.1‡ 

43.8 ± 5.7 

.001 

Times of x-ray exposure 

10 ± 2.0‡

8 ± 1.9

8 ± 1.9

Blood loss (mL) 

2.4 ± 1.1 

2.3 ± 1.0 

.63

Inject cement volume (mL) 

4.6 ± 1.4

4.8 ± 1.3 

.46

Bone cement leakage rate (n/N)

12/51 (23.5%)‡ 

4/49 (8.2%)

.036 

Leakage type

B

1/51

1/49

.74

C

9/51‡

2/49

.03

S

3/51

1/49

.64 

Quantitative data were presented as mean ± standard deviation.

STUDY LIMITATIONS

  • The study compared non-Medtronic instruments.
  • In group 1, a conventional balloon kyphoplasty technology was used (Percutaneous Kyphoplasty System, Shandong Dragon Crown Medical Co., Ltd) and in group 2, a new type of directional balloon dilation technology (Directional Percutaneous Kyphoplasty System, Suzhou and Science & Technology Development Co., Ltd) was used.
  • Data are presented as means ± standard deviation. KA=Kyphosis angle, WA=Wedge-shaped angle.
  • Significant kyphotic angle correction at 3 days could be attributed for early and immediate outcome improvement.
  • Data were presented as mean ± standard deviation:
    • ODI =Oswestry Disability Index
    • RMD = Roland Morris Disability Questionnaire
    • VAS = Visual Analogue Scale
  • Study featured a small sample size and short follow up time. Further research is recommended to determine strength comparison between the controllable directional device, bone and balloon. 
  • Bone cement leakage was classified into 3 types:
    • Type B: Cement leakage along the vertebrobasilar vein to the posterior border of the vertebral body.
    • Type C: Cement leakage mainly along the cortical defect to the intervertebral disc.
    • Type S: Cement leakage mainly around the vertebral body along the intervertebral vein.

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*

Comparison between postoperative and preoperative in each group, P<05.

Group 1 compared with group 2 at different time points, P<.05.

Group 1 compared with group 2, P<.05.

1

Medtronic Data on File

2

Wang P, Li J, Song Z, Peng Z, Wang G. Utilization of the directional balloon technique to improve the effectiveness of percutaneous kyphoplasty in the treatment of osteoporotic vertebral compression fractures and reduction of bone cement leakage. Medicine (Baltimore). 2019;98(19):e15272.