Medtronic K09A Instructions for Use

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