Balloon Kyphoplasty: Orthopedic Treatment for Vertebral (Spinal) Compression Fractures

Balloon kyphoplasty is a minimally invasive option which addresses both the deformity and pain by stabilizing the fracture and helping to correct the vertebral body deformity. Physicians report significant improvements at short and long-term follow-up in patients treated with balloon kyphoplasty, including:

• Correction of vertebral body deformity
• Significant reduction in pain
• Improvement in quality of life
• Improvement in ability to perform activities of daily living
• Low complication rate

About the Procedure
Through a 1 cm incision, a working cannula is placed through the pedicle, after which an orthopedic balloon is guided into the fractured vertebral body (Fig. 3).

The balloon is inflated, reducing the fracture and elevating the superior endplate (Fig. 4). In an attempt to achieve an "en masse" fracture reduction, the procedure is performed bilaterally, using two balloons.

Once the fracture has been reduced, both balloons are deflated and removed, leaving behind a cavity which is then filled with KyphX® HV-R™ Bone Cement under low, manual pressure (Fig. 5).

The procedure typically takes less than one hour per fracture treated and may require a brief hospital stay. After the procedure, the patient should return to the osteoporosis-treating physician for medical management and follow-up.

Figs. 3 through 5

KyphX® Inflatable Bone Tamps 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 with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus. KyphX® 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 balloon kyphoplasty procedure. 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. Kyphon is a registered trademark and HV-R and Ahead of the Curve are trademarks of Kyphon Inc. © 2004 Kyphon Inc. All rights reserved. 16000320-03

Kyphon Inc.
1221 Crossman Ave.
Sunnyvale, CA 94089
www.kyphon.com
Phone: 877-459-7466
Fax: 408-548-6502
email: customerservice@kyphon.com

As with any surgery, there are potential risks. Although balloon kyphoplasty is designed to minimize these risks as much as possible, there is a chance that complications could occur. Serious adverse events can occur including: myocardial infarction (heart attack), cerebrovascular accident (stroke), pulmonary embolism (cement leakage that migrates to the lungs), cardiac arrest (heart stops beating), paralysis or muscle weakness, death. Patients should consult with their doctor for a full discussion of risks.