Professionisti del settore sanitario

Kyphon

Balloon Kyphoplasty

Overview

Kyphon^™ Balloon Kyphoplasty uses orthopaedic balloons to restore vertebral height and correct angular deformity due to vertebral compression fractures (VCFs). After reduction, the balloons are deflated and removed. The resulting cavity (void) allows for a controlled deposition of Kyphon bone cement forming an internal cast and stabilizing 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:

Kyphon Express™ II, an inflatable bone tamp (IBT), has a maximum rated inflation pressure of 700 psi when used with the Kyphon Inflation Syringe. This gives it more power for greater lift force during vertebral body fracture reduction and offers the ability to perform the cement resistant technique, allowing one IBT to remain inflated during contralateral cement fill.

Kyphon Express II offers an expanded tools portfolio with a smaller access profile (10ga) and more balloon sizes and volumes (10mm/3cc, 15mm/4cc, and 20mm/5cc), making it suitable for a variety of spine levels and improving procedure flexibility.¹

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.

Go to the manual library

Product Risks

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

Reference

Medtronic Data on File – Kyphon Express™ II Inflatable Bone Tamps