Balloon kyphoplasty systems

Kyphon™ balloon kyphoplasty platform

<p>The Kyphon™ balloon kyphoplasty platform is an orthopedic balloon system used in the treatment of vertebral compression fractures (VCFs).</p>

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Indications, Safety, and WarningsRisks of balloon kyphoplasty and vertebroplasty proceduresAs with all surgical procedures, there are risks associated with the procedure, including serious complications, and though rare, some of which can be fatal. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the instructions for use included with the product.The complication rate with Kyphon™ balloon kyphoplasty has been demonstrated to be low (< 1% procedure- and cement-related¹).Adverse events potentially associated with use of the inflatable bone tamps (IBT):

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 that may cause injury to the spinal cord or nerve roots resulting in radiculopathy, paresis, or paralysis.

Bleeding or hematoma

Risks of acrylic bone cements include cement leakage which may cause tissue damage, nerve or circulatory problems, and other serious adverse events, such as:

Cardiac arrest

Cerebrovascular accident

Myocardial infarction

Pulmonary embolism

Cardiac embolism

Other reported adverse events relevant to the anatomy being treated with acrylic bone cements include:

Deep or superficial wound infection

Fistula

Hematoma

Hemorrhage

Heterotopic new bone formation

Extravasation of bone cement potentially resulting in but not limited to:

Compression or irritation of nerve structures, such as the spinal cord or nerve roots, causing radiculopathy, paresthesia, paraplegia or paralysis and/or;
Introduction into the vascular system resulting in embolism of the lung and/or heart or other clinical sequelae

Pyrexia due to allergy to bone cement

Short-term conduction irregularities

Thrombophlebitis

Transitory fall in blood pressure

Inflatable bone tamps (IBT) indications for useKyphon Xpander™ and Kyphon Express™ 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 balloon kyphoplasty), hand, tibia, radius, and calcaneus.Bone cement indications for useKyphon Xpede™ bone cement, Kyphon VuE™ bone cement, and Kyphon HV-R™ bone cement are 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. They are 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. Pathologic 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.Kyphon ActivOs™ 10 bone cement with hydroxyapatite is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Quantitative analysis of perioperative complication rates in balloon kyphoplasty and vertebroplasty (meta-analysis). Medtronic Spine LLC; December 11, 2006.

Features

The Kyphon™ platform has a maximum rated inflation pressure of 700 psi.^†
The cement-resistance technique lets you deliver cement through one cannula while the contralateral balloon remains inflated to maintain fracture reduction.

System components

Bone access tools

Kyphon™ access tools are available in a variety of sizes, lengths, volumes, and tip types allowing you to customize based on the needs of your patients.

Cement and delivery systems

There are multiple cement options along with accessories to help meet your procedural needs. Using Kyphon™ bone cement with the Kyphon™ cement delivery system (CDS), you can deliver highly viscous bone cement from up to 48″ away from the radiation source while still maintaining a tactile feel.

The Kyphon™ cement delivery system (CDS) delivers highly viscous bone cement during balloon kyphoplasty procedures.

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Ordering information

Kyphon Express™ 10 ga system

Bone access and biopsy devices

Item number	Description
T34A	Kyphon Express™ Osteo Introducer™ system — diamond, bevel, drill
T34B	Kyphon Express™ Osteo Introducer™ device — trocar
T34C	Kyphon Express™ Advanced Osteo Introducer™ device
T34D	Kyphon Express™ Osteo Introducer™ device — diamond
T34E	Kyphon Express™ Osteo Introducer™ device — bevel
T34F	Kyphon Express™ Osteo Introducer™ device — drill
F07A	Kyphon Express™ bone biopsy device

Kyphon Express™ II kits (700 psi rated) and a la carte options

Item number	Description
KE102	Kyphon Express™ II inflatable bone tamp — 10/2 IBT
KE152	Kyphon Express™ II inflatable bone tamp — 15/2 IBT
KE202	Kyphon Express™ II inflatable bone tamp — 20/2 IBT
KEX102EB	KyphoPak™ tray, 10/2 IBT, Kyphon Express™ II Osteo Introducer™ system
KEX102EB-CDS	KyphoPak™ tray, 10/2 IBT, Kyphon Express™ II Osteo Introducer™ system with CDS system bundle
KEX102NB	KyphoPak™ tray, 10/2 IBT, Kyphon™ additional fracture
KEX152EB	KyphoPak™ tray, 15/2 IBT, Kyphon Express™ II Osteo Introducer™ system
KEX152EB-CDS	KyphoPak™ tray, 15/2 IBT, Kyphon Express™ II Osteo Introducer™ system with CDS system bundle
KEX152NB	KyphoPak™ tray, 15/2 IBT, Kyphon™ additional fracture
KEX202EB	KyphoPak™ tray, 20/2 IBT, Kyphon Express™ II Osteo Introducer™ system
KEX202EB-CDS	KyphoPak™ tray, 20/2 IBT, Kyphon Express™ II Osteo Introducer™ system with CDS system bundle
KEX202NB	KyphoPak™ tray, 20/2 IBT, Kyphon™ additional fracture
A08E	Kyphon™ inflation syringe with locking syringe
A13A	Kyphon Express™ curette

Kyphon Express™ (400 psi related) kits and a la carte options

Item number	Description
K15A	Kyphon Express™ inflatable bone tamp — 10/2 IBT
K15B	Kyphon Express™ Inflatable bone tamp — 15/2 IBT
KPE1001	KyphoPak™ Express™ tray, 10/2 IBT, Kyphon Express™ Osteo Introducer™ system
KPE1001-CDS	KyphoPak™ Express™ tray, 10/2 IBT, Kyphon Express™ Osteo Introducer™ system with CDS system
KPE1002	KyphoPak™ Express™ tray, 10/2 IBT, Kyphon™ additional fracture
KPE1003	KyphoPak™ Express™ tray, 15/2 IBT, Kyphon Express™ Osteo Introducer™ system
KPE1003-CDS	KyphoPak™ Express™ tray , 15/2 IBT, Kyphon Express™ Osteo Introducer™ system with CDS system
KPE1004	KyphoPak™ Express™ tray, 15/2 IBT, Kyphon™ additional fracture
A13A	Kyphon Express™ curette

Kyphon Xpander™ 8 ga system

Kyphon Xpander™ II kits (700 psi rated) and a la carte options

Item number	Description
KPX103RB	KyphoPak™ tray, Kyphon Xpander™ II 10/3 IBT, Kyphon™ Osteo Introducer™ system
KPX103AB	KyphoPak™ tray, Kyphon Xpander™ II 10/3 IBT, Kyphon™ Advanced Osteo Introducer™ system
KPX103NB	KyphoPak™ tray, Kyphon Xpander™ II 10/3 IBT, Kyphon™ additional fracture
KPX103PB	KyphoPak™ tray, Kyphon Xpander™ II 10/3 IBT, Kyphon™ One-Step™ Osteo Introducer™ system
KPX103PB-CDS	KyphoPak™ tray, Kyphon Xpander™ II 10/3 IBT, Kyphon™ One-Step™ Osteo Introducer™ with CDS system
KPX153RB	KyphoPak™ tray, Kyphon Xpander™ II 15/3 IBT, Kyphon™ Osteo Introducer™ system
KPX153RB-CDS	KyphoPak™ tray, Kyphon Xpander™ II 15/3 IBT, Kyphon™ Osteo Introducer™ with CDS system
KPX153AB	KyphoPak™ tray, Kyphon Xpander™ II 15/3 IBT, Kyphon™ Advanced Osteo Introducer™ system
KPX153NB	KyphoPak™ tray, Kyphon Xpander™ II 15/3 IBT, Kyphon™ additional fracture
KPX153PB	KyphoPak™ tray, Kyphon Xpander™ II 15/3 IBT, Kyphon™ One-Step™ Osteo Introducer™ system
KPX153PB-CDS	KyphoPak™ tray, Kyphon Xpander™ II 15/3 IBT, Kyphon™ One-Step™ Osteo Introducer™ with CDS system
KPX203RB	KyphoPak™ tray, Kyphon Xpander™ II 20/3 IBT, Kyphon™ Osteo Introducer™ System
KPX203RB-CDS	KyphoPak™ tray, Kyphon Xpander™ II 20/3 IBT, Kyphon™ Osteo Introducer™ with CDS system
KPX203AB	KyphoPak™ tray, Kyphon Xpander™ II 20/3 IBT, Kyphon™ Advanced Osteo Introducer™ system
KPX203NB	KyphoPak™ tray, Kyphon Xpander™ II 20/3 IBT, Kyphon™ additional fracture
KPX203PB	KyphoPak™ tray, Kyphon Xpander™ II 20/3 IBT, Kyphon™ One-Step™ Osteo Introducer™ system
KPX203PB-CDS	KyphoPak™ tray, Kyphon Xpander™ II 20/3 IBT, Kyphon™ One-Step™ Osteo Introducer™ with CDS system

Kyphon Xpander™ (400 psi rated) kits

Item number	Description
KPT1004	KyphoPak™ tray, Kyphon Xpander™ II 10/3 IBT, Kyphon™ additional fracture
KPT1005	KyphoPak™ tray, Kyphon Xpander™ II 10/3 IBT, Kyphon™ One-Step™ Osteo Introducer™ system
KPT1502	KyphoPak™ tray, Kyphon Xpander™ II 15/3 IBT, Kyphon™ Osteo Introducer™ system
KPT1503	KyphoPak™ tray, Kyphon Xpander™ II 15/3 IBT, Kyphon™ Advanced Osteo Introducer™ system
KPT1504	KyphoPak™ tray, Kyphon Xpander™ II 15/3 IBT, Kyphon™ additional fracture
KPT1505	KyphoPak™ tray, Kyphon Xpander™ II 15/3 IBT, Kyphon™ One-Step™ Osteo Introducer™ system
KPT1505-CDS	KyphoPak™ tray, Kyphon Xpander™ II 15/3 IBT, Kyphon™ One-Step™ Osteo Introducer™ with CDS system
KPT2002	KyphoPak™ tray, Kyphon Xpander™ II 20/3 IBT, Kyphon™ Osteo Introducer™ system
KPT2003	KyphoPak™ tray, Kyphon Xpander™ II 20/3 IBT, Kyphon™ Advanced Osteo Introducer™ system
KPT2004	KyphoPak™ tray, Kyphon Xpander™ II 20/3 IBT, Kyphon™ additional fracture
KPT2005	KyphoPak™ tray, Kyphon Xpander™ II 20/3 IBT, Kyphon™ One-Step™ Osteo Introducer™ system

Kyphon™ Latitude™ II curette used with Kyphon Xpander™ systems

Item number	Description
A11B	Kyphon™ Latitude™ II curette — 8 mm T-tip
A11D	Kyphon™ Latitude™ II curette — 6.5 mm wedge tip
A11E	Kyphon™ Latitude™ II curette — 8.5 mm wedge tip

Kyphon™ bone cement, mixers, and accessories

Item number	Description
C01A	Kyphon™ HV-R™ bone cement
C01B	Kyphon™ HV-R™ bone cement and Kyphon™ mixer pack
CX01B	Kyphon™ Xpede™ bone cement and Kyphon™ mixer pack
C10A	Kyphon™ ActivOs™ bone cement — order with A07A mixer
CT01B	Kyphon VuE™ visually enhanced bone cement and Kyphon™ mixer pack
CDS2A	Kyphon™ cement delivery gun and bone filler device — size 2
CDS3A	Kyphon™ cement delivery gun and bone filler device — size 3
CC02A	Kyphon™ CDS cement cartridges
F04B	Kyphon Xpander™ 8 ga bone filler device
F04C	Kyphon Xpander™ 8 ga directional bone filler device
F06A	Kyphon Express™ 10 ga bone filler device
F06B	Kyphon Express™ 10 ga directional bone filler device
A07A	Kyphon™ mixer
A22	Kyphon™ multi-tap adapter for use with Kyphon Express™ 10 ga bone fillers
A23	Kyphon™ multi-tap adapter for use with Kyphon Xpander™ 8 ga bone fillers
CX01B-MT2	Kyphon™ Xpede™ bone cement with mixer and Kyphon™ A22 multi-tap adapter
CX01B-MT3	Kyphon™ Xpede™ bone cement with mixer and Kyphon™ A23 multi-tap adapter

Resources

Balloon Kyphoplasty Product Portfolio Brochure (open in new window)

See how the portfolio of Kyphon™ balloon kyphoplasty solutions is transforming how compression fractures are treated.

PRODUCT PDF 2 MB

Vertebroplasty Coding and Payment Guide (open in new window)

See reimbursement information for vertebroplasty coding and therapy from Medtronic.

ECONOMICS AND REIMBURSEMENT PDF 210 KB

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† Kyphon Express™ II and Kyphon Xpander™ IBTs have a maximum pressure rating of 700 psi and Kyphon Express™ and Kyphon Xpander™ first generation IBTs have a maximum pressure rating of 400 psi.

Kyphon™ balloon kyphoplasty platform

Features

System components

Bone access tools

Cement and delivery systems

Ordering information

Kyphon Express™ 10 ga system

Bone access and biopsy devices

Kyphon Express™ II kits (700 psi rated) and a la carte options

Kyphon Express™ (400 psi related) kits and a la carte options

Kyphon Xpander™ 8 ga system

Kyphon Xpander™ II kits (700 psi rated) and a la carte options

Kyphon Xpander™ (400 psi rated) kits

Kyphon™ Latitude™ II curette used with Kyphon Xpander™ systems

Kyphon™ bone cement, mixers, and accessories

Resources

Related links

Similar products

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