Overview

GET TO KNOW  KYPHON ASSIST™

Watch the video introduction to Kyphon Assist™ and then click to learn more:

KEY BENEFITS 

More Control + 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 + 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.

CLINICAL EVIDENCE

 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
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.
  • Significantly early and immediate outcome improvement: The improvement in VAS, ODI, and RMD scores is significantly better than nondirectional technique at 3 days

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 Index, RMD = Roland Morris Disability Questionnaire, VAS = Visual Analogue Scale

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

COMPARISON OF INTRAOPERATIVE DATA BETWEEN 2 GROUPS

 

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 

<.01 

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.

LEARN MORE ABOUT KYPHON ASSIST™

Contact your Medtronic Interventional sales representative to get access to this new technology or call Customer Service at 800-933-2635 to be connected with a representative in your region.

Important Product Information 

The Kyphon Assist™ directional cannula is intended for percutaneous access to bone.

The Kyphon Assist™ directional cannula is a single use device intended to contact body tissues. Do not reuse, reprocess, or resterilize. Reusing these devices carries the risk of contamination and may cause patient infection or cross-infection, regardless of the cleaning and resterilization methods. There is also an increased risk of the deterioration of the device performance due to the reprocessing steps, which may lead to patient injury or death. 

Kyphon™ Balloon Kyphoplasty is a minimally invasive procedure for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions. 

The complication rate with Kyphon™ Balloon Kyphoplasty has been demonstrated to be low. There are risks associated with the procedure (e.g., cement extravasation), including serious complications, and though rare, some of which may be fatal. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices’ Instructions for Use included with the product. 

Please see the package insert for the complete list of indications, warnings, precautions, and other important medical information.

 

*

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.