Vertebroplasty

Kyphon V™ premium vertebroplasty platform

<p>The Kyphon V™ premium vertebroplasty platform facilitates precise high-viscosity cement placement in vertebral compression fracture repair.</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

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

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

Reduce hand radiation exposure by

70%

Minimize radiation exposure by standing up to four feet away from the radiation source.¹ Seventy percent hand exposure reduction rate is compared to bone filler device when measured with dosimeters under fluoroscopy.^†

Stop cement flow immediately

Reducing the risk of cement extravasation

This is an image of the Kyphon V™ premium vertebroplasty platform being used in the spine.

Comprehensive access solutions

10 ga, 11 ga, 13 ga straight access tools
Trocar and bevel stylets
13 ga and 15 ga bone biopsy needles

Kyphon™ Kurve

Engineered to optimize flexibility and stiffness
Allows access across midline from unipedicular approach
Features open distal tip for precisely targeted cement flow

Bone cement portfolio

Kyphon HV-R™ bone cement: High-viscosity bone cement
Kyphon Xpede™ bone cement: Quick-to-dough and high-viscosity cement
Kyphon ActivOs™ 10 bone cement with hydroxyapatite: PMMA with 10% hydroxyapatite (w/w) in powder
Kyphon VuE™ bone cement: Visually-enhanced bone cement

Discover vertebral augmentation Find reimbursement resources

Ordering information

Kyphon V™ bone biopsy

Item number	Description
VPB11	Kyphon V™ bone biopsy device — 13 ga, use with 11 ga introducer
VPB11D	Kyphon V™ bone biopsy kit — 13 ga, use with 11 ga introducer
VPB13	Kyphon V™ bone biopsy device — 15 ga, use with 13 ga introducer
VPB13D	Kyphon V™ bone biopsy kit — 15 ga, use with 13 ga introducer

Kyphon Kurve™ bone filler

Item number	Description
VPK1003	Kyphon Kurve™ Kit with 10 ga access
VPT02A	Kyphon Kurve™ curved bone filler device

Kyphon V™ Osteo Introducer™

Item number	Description
VPK011B	Kyphon V™ Osteo Introducer™ matched bevel kit with CDS — 11 ga
VPK011D	Kyphon V™ Osteo Introducer™ trocar and bevel kit with CDS — 11 ga
VPK013B	Kyphon V™ Osteo Introducer™ matched bevel kit with CDS — 13 ga
VPK013D	Kyphon V™ Osteo Introducer™ trocar and bevel kit with CDS — 13 ga
VPK1002	Kyphon V™ Osteo Introducer™ trocar kit with CDS — 10 ga
VPT01B	Kyphon V™ Osteo Introducer™ trocar — 10 ga
VPT11B	Kyphon V™ Osteo Introducer™ matched bevel — 11 ga
VPT11D	Kyphon V™ Osteo Introducer™ trocar and bevel — 11 ga
VPT13B	Kyphon V™ Osteo Introducer™ matched bevel — 13 ga
VPT13D	Kyphon V™ Osteo Introducer™ trocar and bevel — 13 ga

Resources

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

Kyphon V™ premium vertebroplasty platform

Features

Comprehensive access solutions

Kyphon™ Kurve

Bone cement portfolio

Ordering information

Kyphon V™ bone biopsy

Kyphon Kurve™ bone filler

Kyphon V™ Osteo Introducer™

Resources

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