Medtronic C01B Instructions for Use

Kyphon™ HV-R™ (High Viscosity,

M708348B154E Rev. F

Radiopaque) Bone Cement

2021-10-18

IMPORTANT INFORMATION ON KYPHON™ HV-R™ (HIGH VISCOSITY,
RADIOPAQUE) BONE CEMENT

Carefully read all instructions prior to use.

INDICATIONS FOR USE

Kyphon™ HV-R™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to
osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated
for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer
includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign
lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic vertebral body microfracture
(as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

When used in conjunction with CD Horizon™ Fenestrated Screws, Kyphon™ HV-R™ Bone Cement is intended to restore
integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving
the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD
Horizon™ Fenestrated Screws augmented with Kyphon™ HV-R™ Bone Cement are for use at spinal levels where the
structural integrity of the spine is not severely compromised.

DESCRIPTION

Kyphon™ HV-R™ Bone Cement is a polymethylmethacrylate (PMMA) that contains approximately 30% barium sulfate. It is
designed for delivery in a highly viscous state.

Table 1: Nominal Composition of Kyphon™ HV-R™ Bone Cement:
(Actual weight percentages of individual components will vary within accepted ranges.)

Powder (20g of sterile powder in a packet) Liquid (9.0g of sterile liquid in a vial)

Methylmethacrylate-styrene-copolymer 68.0% w/w Methylmethacrylate (monomer) 99.1% w/w
Barium sulfate 30.0% w/w N, N-dimethyl-p-toluidine 0.9% w/w
Benzoyl peroxide 2.0% w/w Hydroquinone 75 ppm

For US Audiences Only

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

CONTRAINDICATIONS

PMMA bone cement is contraindicated in the presence of active or incompletely treated infection at the site where bone cement
is to be applied for treatment of non-pathological, acute, traumatic fractures of the vertebra or sacrum, and in cases involving
either displaced sacral fractures or compromise of the sacral foramina.

WARNINGS

▪ The sterile Kyphon™ HV-R™ Bone Cement is designed and intended for one time use only. Do not re-sterilize and/or re-

use. Sterility is assured only if the unit container is not damaged.

▪ Maintain aseptic surgical technique to prevent possible infection including treatment site infection.
▪ Monitor patients carefully for any change in blood pressure during and immediately following the application of bone

cement. Adverse patient reactions affecting the cardiovascular system, including Bone Cement Implantation Syndrome
(BCIS), have been associated with the use of bone cements. Hypotensive reactions have occurred between 10 and 165
seconds following application of bone cement. The reactions lasted from 30 seconds to 5 or more minutes. Some have
progressed to cardiac arrest. Patients should be monitored carefully for any change in blood pressure during and
immediately following the application of bone cement, especially those potentially at increased risk for peri-operative death
including elderly patients, patients with underlying cardiac or pulmonary compromise, and patients being treated for multiple
vertebral body fractures in one procedure.

▪ Cement leakage may cause tissue damage, nerve or circulatory problems, and other serious adverse events. These risks

may increase with the number of spinal levels where bone cement is used, and also with the volume of bone cement used.

▪ Caution should be exercised during the mixing of the two components to prevent excessive exposure to concentrated

vapors of the monomer, which may produce irritation of the respiratory tract, eyes, and possibly liver.

▪ Polymerization of bone cement is an exothermic reaction which occurs while the cement is hardening in situ. According to

the ISO 5833 standard, the temperature can be as high as 90°C ± 5°C. Released heat may damage bone or other tissues
surrounding implants.

▪ The liquid component is a powerful lipid solvent. It should not be allowed to come into contact with rubber or latex gloves.

Should contact occur, gloves may dissolve and tissue damage may occur. Wearing a second pair of gloves and adherence
to mixing instructions may diminish the possibility of hypersensitivity reactions. Mixed bone cement should not make contact
with the gloved hand until bone cement is being tested for the consistency of dough.

▪ Personnel wearing permeable contact lenses should not be near or involved in mixing bone cement. Soft contact lenses are

permeable.

▪ Handling characteristics of bone cement are affected by operating room conditions including room temperature,

temperature of cement components prior to mixing, humidity, geometry of the mixing apparatus, time spent mixing, and
geometry of the delivery device. Changes in one or more of these conditions can alter handling characteristics of bone
cement, including:

▪ Handling period - time it takes for the bone cement to reach the doughy state. Cement has reached the doughy state

when it no longer sticks to surgical gloves.

▪ Working period - time bone cement remains in the doughy state and can be delivered.
▪ Hardening period - time needed for bone cement to harden or until it can no longer be delivered.

Users must be aware of these factors and adjust technique to account for variability in operating room conditions.

▪ Avoid over-pressurization of bone cement and do not insert bone cement into the cavity of the vertebral body until bone

cement has reached the doughy state. Cement has reached the doughy state when it no longer sticks to surgical gloves.
Maintain patient positioning until the end of the polymerization process. Failure to do so may lead to extravasation of bone
cement beyond the site of its intended application and may or could damage surrounding tissues.

▪ Safety of bone cement in pregnant women or in children was not established. Bone cement may adversely affect bone

growth and fetal health.

▪ Difficulty in swallowing and blistering of the throat, alleged to be an allergic reaction to the use of bone cement, have also

been reported.

▪ Do not mix more than one vial of liquid and one packet of powder together at any one time. Never modify ratios between

liquid and solid components. Doing so can affect bone cement properties including handling characteristics.

▪ Long-term follow-up is advised for all patients on a regularly scheduled basis. Inadequate filling or unanticipated

postoperative events may affect stability of bone cement and/or the bone cement-bone interface. A fibrous tissue layer may
develop between cement and the bone and loosening of bone cement may occur leading to failure.

▪ Kyphon™ HV-R™ Bone Cement is provided in finished form with all necessary components for use. The addition of a

radiopacifier (e.g. barium, antibiotics, or other drugs or materials) to Kyphon™ HV-R™ Bone Cement is not recommended.
Never add other substances or foreign bodies to the acrylic resin. Safety and effectiveness of adding such drugs or
materials was not evaluated and may cause patient harm.

▪ Modifying polymerization time by either warming or cooling bone cement and/or associated delivery devices was not tested

and could affect bone cement properties including handling characteristics.

PRECAUTIONS

▪ Keep the product at a temperature of 23 ± 1°C for a period of 24 hours prior to use.
▪ Never deliver bone cement into the vertebral body without the use of high quality fluoroscopic guidance capable of

visualizing movement of bone cement.

▪ Only physicians thoroughly trained in pedicle screw placement, and the surgical use of bone cement and balloon

kyphoplasty should use Kyphon™ HV-R™ Bone Cement. Users should have specific training and be familiar with
properties, handling characteristics, and application of bone cement and adhere to instructions for use.

▪ Do not use after the expiration date printed on the package. The device may not be safe or effective beyond its expiration

date.

▪ Do not use if package is opened or damaged because product integrity including sterility may be compromised.
▪ Do not use damaged products. Prior to use, inspect the packaging and product to verify no damage has occurred.
▪ Follow mixing and handling instructions to avoid contact dermatitis. Strict adherence to instructions for mixing powder and

liquid components may reduce the incidence of this complication.

▪ Adequately ventilate the operating room to eliminate as much monomer vapor as possible. Liquid monomer is highly volatile

and flammable. Ignition of monomer fumes caused by use of electrocautery devices in surgical sites near freshly implanted
bone cements has been reported.

▪ Dispose of the polymer component in an authorized waste facility. The liquid component can be evaporated under a well-

ventilated hood or absorbed by an inert material and transferred in a suitable container for disposal.

▪ Use imaging techniques during needle placement and during injection. Extravasation can occur during cement injection if

the needle is in an artery or vein, or if unseen microfractures are prevalent. Embolization can also occur if the needle is
placed in an artery or vein. Cement extravasation may cause tissue damage, nerve or circulatory problems, and increase
risk for future fractures.

▪ If bone cement is seen outside of the vertebral body/sacrum or in the circulatory system during the procedure, immediately

stop the injection.