KYPHON™ XPANDER™ Inflatable
M708348B151E Rev. C
Bone Tamp (Sizes 10/3, 15/3 and 20/3)
KYPHON™ EXPRESS™ Inflatable
Bone Tamp (Sizes 10/2 and 15/2)
2017-10-17
IMPORTANT INFORMATION ON THE KYPHON™ XPANDER™ INFLATABLE BONE
TAMP (Sizes 10/3, 15/3 and 20/3) AND THE KYPHON™ EXPRESS™ INFLATABLE
BONE TAMP (Sizes 10/2 and 15/2)
INDICATIONS FOR USE
KYPHON™ XPANDER™ and KYPHON™ EXPRESS™ Inflatable Bone Tamps (IBT) are intended to be used as conventional
bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during a
balloon kyphoplasty procedure with KYPHON™ HV-R™ Bone Cement), hand, tibia, radius, and calcaneus.
DEVICE DESCRIPTION
See Figure 1.
1. Cap
2. Stylet
3. Stylet Port
4. Inflation Port
5. Color Coded Band
6. Exit Marker Band
7. Insertion Sleeve
8. Radiopaque Markers (see the lower portion of Figure 1 for a cross-sectional ballon view)
9. Inflatable Component (see the lower portion of Figure 1 for a cross-sectional ballon view)
▪ The working surface of the IBT is designed to compress cancellous bone and/or move cortical bone as it inflates. The
Inflatable Component of the IBT is near the distal tip of the device as shown in Figure 1.
▪ The shaft contains two non-communicating lumens. The outer lumen is used for IBT inflation, and the central lumen
contains a removable stiffening Stylet for IBT insertion.
▪ The proximal end of the shaft has a side-arm adapter. The Inflation Port of the adapter is contiguous with the outer lumen.
The Stylet Port is contiguous with the inner lumen and contains the stiffening Stylet. The Stylet has a Cap at its proximal
end for optional removal.
▪ The Color Coded Band, located just distal to the side-arm adapter, indicates the balloon size (i.e. a yellow band for 10/2 and
10/3 sizes, a black band for 15/2 and 15/3 sizes, a clear/white band for 20/3 size).
▪ The Exit Marker Band located on the outer lumen is used during IBT insertion.
▪ Radiopaque Markers located at the distal and proximal end of the deflated working surface allow fluoroscopic visualization
of the deflated IBT during positioning.
For US Audiences Only
Caution: federal (USA) law restricts this device to sale by or on the order of a physician.
WARNINGS
Breakage of the device may require intervention or retrieval.
PRECAUTIONS
▪ The KYPHON™ XPANDER™ and KYPHON™ EXPRESS™ Inflatable Bone Tamps are single use devices 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.
▪ It is important to read the Instructions For Use and these precautions carefully prior to device operation.
▪ Use the IBT prior to the use by date noted on the package.
▪ Do not use if package is opened or damaged because product integrity including sterility may be compromised.
▪ Do not use damaged products. Before use, inspect the IBT and packaging to verify that no damage has occurred.
▪ Prior to use, the IBT should be examined to verify functionality and ensure that its size is suitable for the specific procedure
for which it is to be used.
▪ Do not use this product if you have not been properly trained. The IBT should only be used by physicians who are trained in
the techniques of bone tamp use. Physicians using the devices should be familiar with the physiology and pathology of the
selected anatomy.
▪ The IBT should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high
quality images.
▪ The IBT should only be inflated using an Inflation Syringe having a 20ml volume capacity.
▪ Only inflate the IBT with liquid contrast medium: a 60% solution is recommended. Follow manufacturer’s instructions for
contrast medium indications, usage and cautions.
▪ Do not use air or other gas to inflate the IBT.
▪ The Inflatable Component of the IBT may fail due to contact with bone splinters, bone cement and/or surgical tools.
▪ The inflation characteristics of the IBT are altered by inflation inside bone.
▪ Reconditioning, refurbishing, repair, modification, or resterilization of the device to enable further use is expressly
prohibited.
Note: the KYPHON™ XPANDER™ Inflation Syringe provides superior volume control compared to other inflating systems,
such as a standard syringe, and is required for inflation of the IBT. Follow the manufacturer’s Instructions for Use of the
KYPHON™ XPANDER™ Inflation Syringe. The KYPHON™ Locking Syringe is packaged with the KYPHON™ XPANDER™
Inflation Syringe.
Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information given in this document should be conveyed to the patient.
ADVERSE EVENTS
Adverse events potentially associated with use of the IBT include:
▪ Embolism of fat, thrombus or other materials resulting in symptomatic pulmonary embolism or other clinical sequelae.
▪ Rupture with fragmentation of the inflatable portion of the IBT resulting in retention of a fragment within the vertebral body.
▪ Rupture of the IBT causing contrast medium exposure, possibly resulting in an allergic reaction or anaphylaxis.
▪ Deep or superficial wound infection.
▪ Retropulsed vertebral body bone fragments which may cause injury to the spinal cord or nerve roots resulting in
radiculopathy, paresis, or paralysis.
▪ Bleeding or hematoma.
DIRECTIONS FOR USE
Caution: follow the manufacturer’s Instructions for Use of the KYPHON™ XPANDER™ Inflation Syringe.
Caution: contrast media may have different viscosity and precipitation levels that may cause slower inflation and deflation times.
For this reason, the use of 60% contrast medium is recommended.
1. Twist Cap on Stylet Port to tighten Stylet on IBT. Push plunger all the way into the KYPHON™ Locking Syringe. Attach the
KYPHON™ Locking Syringe to Inflation Port (4) on IBT.
2. Pull the KYPHON™ Locking Syringe plunger back. Turn plunger to lock it in position on the last slot in syringe.
3. Detach the KYPHON™ Locking Syringe from IBT.
4. Attach connecting port on KYPHON™ XPANDER™ Inflation Syringe tubing to Inflation Port on IBT. The system is now
prepared and ready to use.
Use of the IBT
1. Select IBT size based on site and treatment goal. Figure 1 and Tables 1 and 2 define the inflated diameter (D) and inflated
length (L) of the IBTs in 37°C water at inflation volume increments to the maximum inflation volume.
2. These dimensions may vary during product use due to local variation in bone structure.
Table 1: KYPHON™ XPANDER™ IBT Inflated Dimensions (in 37°C water)
Model Number K13A Inflated Dimensions
Size 10/3 Volume Diameter (D1, D2) Length (L)
Max. Inflation Volume 4ml 2ml 9.6mm 11.8mm
Table 1: KYPHON™ XPANDER™ IBT Inflated Dimensions (in 37°C water)
Max. Inflation Pressure 400psi (27ATM) 4ml 15.6mm 17.3mm
Model Number K09A Inflated Dimensions
Size 15/3 Volume Diameter (D1, D2) Length (L)
Max. Inflation Volume 4ml 2ml 8.5mm 14.6mm
Max. Inflation Pressure 400psi (27ATM) 4ml 14.3mm 19.7mm
Model Number K08A Inflated Dimensions
Size 20/3 Volume Diameter (D1, D2) Length (L)
Max. Inflation Volume 6ml 2ml 8.0mm 18.4mm
Max. Inflation Pressure 400psi (27ATM) 4ml 12.9mm 24.3mm
6ml 15.8mm 28.2mm
Table 2: KYPHON™ EXPRESS™ IBT Inflated Dimensions (in 37°C water)
Model Number K15A Inflated Dimensions
Size 10/2 Volume Diameter (D1, D2) Length (L)
Max. Inflation Volume 4ml 2ml 11.6mm 15.1mm
Max. Inflation Pressure 400psi (27ATM) 4ml 15.5mm 21.1mm
Model Number K15B Inflated Dimensions
Size 15/2 Volume Diameter (D1, D2) Length (L)
Max. Inflation Volume 5ml 2ml 8.3mm 15.3mm
Max. Inflation Pressure 400psi (27ATM) 4ml 13.8mm 22.0mm
5ml 15.1mm 24.8mm
IBT Insertion
1. An access channel is required for IBT placement.
2. Follow the Instructions for Use for the chosen KYPHON™ bone access tools to create an access channel into the bone.
3. Remove Insertion Sleeve prior to use.
Note: The distal tip of the deflated IBT has reached the distal end of the cannula when the Exit Marker on the outer lumen of
the IBT enters the proximal end of the cannula.
4. Place the deflated IBT into the access channel and position it under image guidance using the Radiopaque Markers. A
gentle twisting motion with the forward push can aid insertion.
5. While holding the IBT in place, inflate to 44psi (3ATM) to secure IBT in position. Remove the Stylet, if desired.
IBT Inflation
1. Inflate the IBT under continuous image guidance. Use the lateral view to monitor distance from the anterior and lateral
cortex. Use the AP view to monitor the lateral cortices.
2. If continuous imaging is not used, increase the volume in small increments (0.25 – 0.5ml). Assess tamp position in lateral
and AP views before proceeding to further volume increase.
3. Stop when treatment goal is achieved: any part of the IBT inflated length contacts cortical bone or maximum inflation
volume and/or maximum inflation pressure is attained (see Table 1).
IBT Removal
Caution: never withdraw the IBT unless the Inflatable Component is fully deflated. Never withdraw the IBT against resistance.
Determine the cause of resistance under fluoroscopy and take the necessary remedial actions.
Unlock the KYPHON™ XPANDER™ Inflation Syringe and evacuate the contrast medium from the IBT until the balloon is
completely deflated. Remove the IBT from the bone through the cannula with a gentle twisting motion.
▪ If there is resistance, connect a 30ml syringe to the Inflation Port. Pull the syringe plunger back to the “30ml” mark to create
a vacuum. Resume the IBT removal.
▪ Confirm entry of the inflatable portion of the IBT into the cannula. If the Inflatable Component does not move into the
cannula, advance the cannula over the IBT to the proximal Radiopaque Marker. Following cannula advancement, withdraw
the IBT through the cannula. If resistance is noted, remove IBT and cannula simultaneously.
Completion of the Balloon Kyphoplasty Procedure
KYPHON™ HV-R™ Bone Cement may be introduced using the KYPHON™ or KYPHON™ EXPRESS™ Bone Filler Device
following void creation in a pathological fracture of the vertebral body. Refer to the KYPHON™ HV-R™ Bone Cement and
KYPHON™ or KYPHON™ EXPRESS™ Bone Filler Device Instructions for Use.
WHERE TO FIND ADDITIONAL INFORMATION
Several large clinical studies, following patients for at least 12 months after vertebral compression fracture, have concluded
mortality rates following vertebral compression fracture are significantly higher for patients treated conservatively (non-operative
treatment), versus with vertebroplasty or balloon kyphoplasty; while other studies have concluded no difference. For more
information and a review of relevant publications, please visit
www.medtronic.com/bkpmortality
STERILIZATION
Sterilized with irradiation.
HOW SUPPLIED
The KYPHON™ XPANDER™ and KYPHON™ EXPRESS™ IBTs are supplied sterile in a peel-open package. In the event of
damage to the sterile packaging, do not use and notify the manufacturer.
MATERIALS NOT SUPPLIED
▪ KYPHON™ XPANDER™ Inflation Syringe with KYPHON™ Locking Syringe
▪ Contrast Medium (60%)
▪ Small Bowl
Note: KYPHON™ XPANDER™ Inflation Syringe with KYPHON™ Locking Syringe is available from Medtronic.
STORAGE
The IBTs should be stored in their original shipping materials. Proper care should be taken to ensure the IBTs will not be
damaged. Store in a cool dry place.
LIMITATION OF LIABILITY
In no event shall Medtronic be liable for any direct, indirect, incidental, consequential, or exemplary damages arising out of or in
connection with the KYPHON™ XPANDER™ and KYPHON™ EXPRESS™ Inflatable Bone Tamps, based upon breach of
contract (including breach of warranty).
FURTHER INFORMATION
In case of complaint, or for supplementary information, contact Medtronic.
©2017 Medtronic Sofamor Danek USA, Inc. All rights reserved.
Figure 1
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
EXPLANATION OF SYMBOLS
Authorized representative in the European Community
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00
CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
The device complies with European Directive MDD
93/42/EEC
Do not re-use
Batch code
Manufacturer
Use-by date
Catalogue number
Sterilized using irradiation
Do not resterilize
Do not use if package is damaged
Consult instructions for use
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