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The Kyphon Assist™ directional cannula provides more predictable inflation and direction of cavity creation during balloon kyphoplasty surgery for vertebral compression fractures. Available in both 8 ga and 10 ga.
DOWNLOAD THE HCP GUIDEWatch the video introduction to the Kyphon Assist™ directional cannula.
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.
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™ 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.
Note: When using the Kyphon Assist™ 10 ga directional cannula (T34S) with the Kyphon Express 400 psi-rated IBTs, item numbers K15A (10 mm) and K15B (15 mm), the maximum inflation volumes are reduced by 1 cc for adjusted maximum inflation volumes of 3 cc (K15A) and 4 cc (K15B).
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:
|
|
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 |
21.0 ± 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.
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 ± deviation.
Access ready-made marketing and patient education tools.
GET TOOLSComparison between postoperative and preoperative in each group, P<05.
Group 1 compared with group 2 at different time points, P<.05.
Medtronic data on file. ETR31101239.
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.