Balloon Kyphoplasty

For Vertebral Compression Fractures

OVERVIEW

Balloon kyphoplasty is a minimally invasive procedure designed to repair vertebral compression fractures (VCFs) by reducing and stabilizing the fractures. It treats pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions.

20 Years of Balloon Kyphoplasty

Learn how Medtronic balloon kyphoplasty has transformed the treatment of vertebral compression fractures (VCF) since Medtronic pioneered the therapy 20 years ago.
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How It Works

The goal of balloon kyphoplasty is to relieve pain, restore lost vertebral body height, and stabilize the fracture. The procedure involves the insertion of two inflatable bone tamps (balloons), or IBTs, into the vertebrae. The IBTs are inflated under volumetric control, reducing the fracture and pushing the endplates apart, thereby partially restoring vertebral height and correcting angular deformity.1 The newly formed cavity is filled with bone cement after IBT removal.

Kyphon Balloon Kyphoplasty Procedure Animation

See how the Kyphon Balloon Kyphoplasty and Cement Delivery System are used to administer the balloon kyphoplasty procedure for vertebral compression fractures.
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Balloon Kyphoplasty Procedure

Through a pair of small incisions, each approximately 1 cm in length, the specialty physician uses a needle and cannula to create a small pathway into each side of a fractured vertebral body. A small balloon is guided through each cannula into the vertebra. Each balloon is carefully inflated in an attempt to raise the collapsed vertebra and return it to its normal position. Inflation of the balloon creates a void (cavity) in the vertebral body.

Once the vertebra is in the correct position, the balloons are deflated and removed. The resultant cavities are filled with bone cement forming an “internal cast” to support the surrounding bone and prevent further collapse.

The balloon kyphoplasty procedure typically takes about one hour per fracture and may be performed in an outpatient setting. The procedure can be done using either local or general anesthesia; the specialty physician will determine the most appropriate method, based on the patient’s overall condition.

20 YEARS OF CLINICAL EVIDENCE

Medtronic has 20 years of providing clinical research to support patient care.

Over the past 20 years, Medtronic has been committed to gathering clinical data on balloon kyphoplasty (BKP) and vertebroplasty (VP). Patients are central to our Mission, and that’s why Medtronic supports VCF research through randomized controlled trials and observational studies as well as big-data healthcare claims analysis.

While BKP/VP is not for everyone, BKP /VP are important treatment options to consider for patients with VCF due to osteoporosis, cancer, or benign lesion. 

See five key studies that demonstrate efficacy of Kyphon balloon kyphoplasty for VCF.

Understanding Mortality Risks for Patients with VCF

VCFs are associated with a downward spiral of complications, including decreased mobility, pain, and function.  

VCFs are also associated with an increased risk of mortality.   Medtronic has summarized recent peer-reviewed manuscripts that described the mortality rates of patients treated with BKP, VP or non-surgical management in recent, large (>1,000 subjects) clinical studies with follow-up of at least 12 months post-fracture.9-14  For information on this research, visit  www.medtronic.com/bkpmortality

Prevalence of VCFs

Osteoporosis, a condition characterized by low bone mass and deterioration in the micro architecture of bone tissue, causes more than 750,000 - 800,000 spinal fractures each year in the U.S.14

Vertebral fractures are the most common osteoporotic fractures, yet approximately two-thirds are undiagnosed and untreated.16

  • Patients have as much as a 5-fold increased risk of another fracture within 1 year of initial fracture.16
  • Incidence of vertebral compression fracture increases progressively with age throughout later life.16

IMPORTANT SAFETY INFORMATION

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.

*Non-surgical management included analgesics, bed rest, bracing, physiotherapy, rehabilitation programs, walking aids, calcium and vitamin D supplements, and antiresorptive or anabolic agents.

1

Wardlaw D, Van Meirhaeghe J, Ranstam J, et al. Balloon kyphoplasty in patients with osteoporotic vertebral compression fractures. Expert Rev Med Devices. 2012 Jul;9(4):423-36.

2

Boonen S, Van Meirhaeghe J, Bastian L, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res. 2011;26(7):1627-1637.

3

Van Meirhaeghe J, Bastian L, Boonen S, et al. A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters. Spine. 2013;38(12):971-983.

4

Dohm M, Black CM, Dacre A, Tillman JB, Fueredi G; KAVIAR investigators. A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis. AJNR Am J Neuroradiol. 2014;35(12):2227-2236.

5

Medtronic data on file. Tillman J, Shabe P, Rose M, et al. Fracture reduction evaluation study 24-month final clinical study report, August 27, 2010. Medtronic Spinal and Biologics Europe BVBA.

6

Berenson J, Pflugmacher R, Jarzem P, et al. Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol. 2011;12(3):225-235.

7

Wardlaw D, Cummings SR, Van Meirhaeghe J, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009;373(9668):1016-24.

8

Tillman J, Shabe P, Rose M, Elson P, Wülfert E, Ashraf T. Fracture Reduction Evaluation Study 24-month final clinical study report, August 27, 2010. Medtronic Spinal and Biologics Europe BVBA. fractures (VCFs) due to osteoporosis. Am J Neuroradiol. 2014;35(12):2227-2236.

9

Ong KL, Beall DP, Frohbergh M et al. Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials. Osteoporos Int. 2017 Oct 24. doi: 10.1007/s00198-017-4281-z.

10

Edidin AA, Ong KL, Lau E, Kurtz SM. Morbidity and mortality after vertebral fractures: comparison of vertebral augmentation and nonoperative management in the Medicare population. Spine. 2015;40(15):1228-1241.

11

Edidin AA, Ong KL, Lau E, Kurtz SM. Mortality risk for operated and nonoperated vertebral fracture patients in the Medicare population. J Bone Miner Res. 2011;26(7):1617-1626.

12

Chen AT, Cohen DB, Skolasky RL. Impact of nonoperative treatment, vertebroplasty, and kyphoplasty on survival and morbidity after vertebral compression fracture in the Medicare population. J Bone Joint Surg Am. 2013;95(19):1729-36.

13

Lange A, Kasperk C, Alvares L, Sauermann S, Braun S. Survival and cost comparison of kyphoplasty and percutaneous vertebroplasty using German claims data. Spine. 2014;39(4):318-26.

14

McCullough BJ, Comstock BA, Deyo RA, Kreuter W, Jarvik JG. Major medical outcomes with spinal augmentation vs conservative therapy. JAMA Intern Med. 2013;173(16):1514-21.

16

Brunton S, Carmichael B, Gold D et al. Vertebral compression fractures in primary care: recommendations from a consensus panel. J Fam Pract. 2005;54(9):781-788.