REVIEW THE FIVE KEY STUDIES

Our priority has always been to raise awareness of available treatments for vertebral compression fractures (VCF) and to refine our innovative technology in partnership with physicians and patients.     

VCFs are associated with a downward spiral of complications, including decreased mobility, pain, and function.1 Clinical evidence has shown that balloon kyphoplasty (BKP) has offered important clinical benefits compared to non-surgical management, including pain relief, reduced opioid use, and improved quality of life.2-6

Kyphon™ balloon kyphoplasty is celebrating more than 20 years of reliability, partnership, and confidence. Explore summaries of five studies sponsored by Medtronic that test the efficacy of the Medtronic Kyphon™ balloon platform.

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EVOLVE STUDY²

KAVIAR STUDY³

CAFE STUDY⁴

FREE STUDY¹

FREE STUDY (PREDICTOR ANALYSIS)⁶

KYPHON™ PRODUCTS

Find Medtronic products for vertebral augmentation procedures. 

SEE PRODUCTS

CLINICAL  OUTCOMES 

Explore additional clinical data for vertebroplasty and balloon kyphoplasty procedures.

 EXPLORE CLINICAL DATA 
1

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.

2

Beall DP, Chambers MR, Thomas S, et al. Prospective and multicenter evaluation of outcomes for quality of life and activities of daily living for balloon kyphoplasty in the treatment of vertebral compression fractures: the EVOLVE trial. Neurosurgery. 2019;84:169-178.

3

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;35:2227-2236.

4

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 Oncology. 2011;12:225-235.

5

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;26:1627-1637.

6

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;38:971-983.

*

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