Healthcare Professionals

Kyphon

Balloon Kyphoplasty

Overview

Kyphon Balloon Kyphoplasty uses orthopaedic balloons to restore vertebral height and correct angular deformity from vertebral compression fractures (VCF) due to osteoporisis, cancer, or benign lesion. After reduction, the balloons are deflated and removed. The resulting cavity (void) allows for a controlled deposition of Kyphon bone cement — which helps form an internal cast and stabilize the fracture.

INDICATIONS

The Kyphon Balloon Kyphoplasty platform is used to treat pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions. 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.

PRODUCT DETAILS

Components of the Kyphon Balloon Kyphoplasty system include:

Use of bilateral balloon kyphoplasty increases the lift force with less exerted stress on the in vitro model endplate vs. unilateral balloon kyphoplasty based on an engineering test environment that measured balloon lift force, balloon contact area and balloon exerted stress.  

Results indicated that the unilateral and bilateral approaches to balloon kyphoplasty are statistically significant in all features assessed.  The bilateral approach yielded a lift force that was 105% greater than the unilateral approach (102.66lbf v. 49.99lbf, respectively).  The bilateral approach had a contact area that was 279% compared to the unilateral approach (1.34in2 v. 0.48in2, respectively).  The exerted stress for the bilateral approach was 26% less than that of the unilateral approach (77.97psi v. 105.00psi, respectively).  

Medtronic Advantages

  • 700 psi max rated inflation pressure, higher than previous 400 psi rated balloons*
  • Cement resistance technique allows delivery of cement through one cannula while the contralateral balloon remains inflated to maintain fracture reduction
  • Kyphon Cement Delivery System (CDS) lets you deliver cement from up to 48 inches away from the radiation source during a kyphoplasty procedure

MANUALS AND TECHNICAL GUIDES

Download technical manuals for Kyphon products from the Medtronic manual library. You can search by model number or enter “Kyphon” in the Product Name field.

Product Risks

The complication rate with Kyphon™ Balloon Kyphoplasty has been demonstrated to be low. There are risks associated with the procedure (e.g., cement extravasation), including serious complications, and through rare, some of which may be fatal.

  • 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.
  • For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices’ Instructions for Use included with the product.
*

Express II has a maximum pressure rating of 700 psi while Express has a maximum pressure rating of 400 psi.