KPA15A

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<h2>Indications, Safety, and Warnings</h2> <h3>Risks of balloon kyphoplasty and vertebroplasty procedures</h3> <p>As 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.</p> <p>The complication rate with Kyphon™ balloon kyphoplasty has been demonstrated to be low (< 1% procedure- and cement-related<sup>1</sup>).</p> <h3>Adverse events potentially associated with use of the inflatable bone tamps (IBT):</h3> <ul> <li>Embolism of fat, thrombus, or other materials resulting in symptomatic pulmonary embolism or other clinical sequelae</li> <li>Rupture with fragmentation of the inflatable portion of the IBT resulting in retention of a fragment within the vertebral body</li> <li>Rupture of the IBT causing contrast medium exposure, possibly resulting in an allergic reaction or anaphylaxis</li> <li>Deep or superficial wound infection</li> <li>Retropulsed vertebral body bone fragments that may cause injury to the spinal cord or nerve roots resulting in radiculopathy, paresis, or paralysis.</li> <li>Bleeding or hematoma</li> </ul> <p>Risks of acrylic bone cements include cement leakage which may cause tissue damage, nerve or circulatory problems, and other serious adverse events, such as:</p> <ul> <li>Cardiac arrest</li> <li>Cerebrovascular accident</li> <li>Myocardial infarction</li> <li>Pulmonary embolism</li> <li>Cardiac embolism</li> </ul> <p>Other reported adverse events relevant to the anatomy being treated with acrylic bone cements include:</p> <ul> <li>Deep or superficial wound infection</li> <li>Fistula</li> <li>Hematoma</li> <li>Hemorrhage</li> <li>Heterotopic new bone formation</li> <li>Extravasation of bone cement potentially resulting in but not limited to:<ul> <li>Compression or irritation of nerve structures, such as the spinal cord or nerve roots, causing radiculopathy, paresthesia, paraplegia or paralysis and/or;</li> <li>Introduction into the vascular system resulting in embolism of the lung and/or heart or other clinical sequelae</li> </ul> </li> <li>Pyrexia due to allergy to bone cement</li> <li>Short-term conduction irregularities</li> <li>Thrombophlebitis</li> <li>Transitory fall in blood pressure</li> </ul> <h3>Inflatable bone tamps (IBT) indications for use</h3> <p>Kyphon 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.</p> <h3>Bone cement indications for use</h3> <p>Kyphon 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.</p> <p>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).</p> <ol> <li>Quantitative analysis of perioperative complication rates in balloon kyphoplasty and vertebroplasty (meta-analysis). Medtronic Spine LLC; December 11, 2006.</li> </ol>

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