Description
With over 25 years of commitment to procedural options and clinical evidence, Medtronic's balloon kyphoplasty empowers you to treat VCF patients with the unmatched innovations of a reliable, robust product platform.
Unmatched commitment to the advancement of a minimally invasive therapy, and to thinking beyond the procedure.
More force
Kyphon Xpander™ II and Kyphon Express™ II inflatable bone tamps are rated to 700 psi, allowing greater lift force for vertebral body fracture reduction.15 *
More technique flexibility
Cement resistance technique allows delivery of cement through one cannula while the contralateral balloon remains inflated to maintain fracture reduction.†
More reduction in radiation
Reduce your hand radiation exposure by more than 80% using the Kyphon™ cement delivery system, allowing you to stand up to 120 cm away from the radiation source.5
More control
A quick-release button halts cement flow instantly1 to minimize the potential for cement extravasation. Each full squeeze of the lever ejects approximately 0.2 cc of bone cement.
More choices
Treat more spine levels and improve your procedural flexibility with our broad portfolio of tools. A variety of bone cements offers choices for minimally invasive injection into vertebrae.
More options, more control
We offer a robust line of tools for treating VCF. Treat more spine levels and improve your procedural flexibility with our broad portfolio of tools.
Kyphon™ access tools can be used for percutaneous access to bone and the delivery of bone cement during kyphoplasty and vertebroplasty procedures. Physicians can choose the length and volume option most appropriate for the individual patient, vertebral body, and fracture.
The Kyphon™ platform offers the choice of 10 mm, 15 mm, and 20 mm balloons, providing more procedural flexibility.
Two systems: 10-Gauge Kyphon™ Express™ system for lower profile small vertebral bodies and 8-Gauge Kyphon™ Xpander™ system for treating thoracic/lumbar vertebral compression fractures.
A variety of bone cements offers choices for minimally invasive injection into vertebrae.
Kyphon Assist™ Cannula
- Provides more predictable inflation and direction of cavity creation
- Can increase the directional height by 37% for more height restoration potential4
- Provides the ability to inflate away from the lateral walls and endplate defects
Cement Delivery System (CDS)
- 120cm tubing keeps implanter further from the source of radiation
- Reduces by 80% radiation exposure5
- Immediate stop button
- 0.2cc per squeeze
Kyphon Express™ Curette
- Scores bone and improves channel creation
- Curette aids void creation and balloon positioning by creating a channel for balloon insertion and inflation
- Torque reset mechanism resets device to minimize breakage when tip encounters excess torsion
Kyphon™ Multi-tap Adapter™
- Enables all Kyphon™ Bone Filler Devices to be filled simultaneously
- Reduces the number of steps required to dispense PMMA based cements
- Can be utilized with Xpede™, HV-R™ and ActivOs™ bone cement
Kyphon™ Inflation Syringe (KIS)
- Digital gauge for easy pressure tracking
- Kyphon V-Klip™ accessory allows holding 2 KIS in one hand
- Depress-release handle and trigger widened
- 58cm tubing to rotating weighted lure
Kyphon™ Inflatable Bone Tamps (IBT)
- 8 ga and 10 ga introducers in 3 lengths to address differing vertebral anatomy
- Generation II IBTs maintain inflation during contra-lateral cement fill†
- Balloon pressure of 700 psi allows potential for continued inflation when encountering resistance*
Procedure
The goal of balloon kyphoplasty surgery 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.11 The newly formed cavity is filled with bone cement after IBT removal.
Powerful clinical evidence
Our priority has always been to raise awareness of available treatments for vertebral compression fractures and to refine our innovative technology in partnership with physicians.
VCFs are associated with a downward spiral of complications, pain, and decreased mobility and function.8 Clinical evidence has shown that balloon kyphoplasty has offered important clinical benefits, including pain relief, reduced opioid use, and improved quality of life.9-13
Kyphon™ balloon kyphoplasty is supported by a robust body of clinical evidence. Explore the studies:
Free study11,13
Review the results of a landmark 24-month study demonstrating the benefits of Kyphon™ balloon kyphoplasty over non-surgical treatment.
Mortality risk18-23
Peer-reviewed studies have evaluated mortality rates in patients treated with balloon kyphoplasty compared to other treatments.
Cafe study12
The Cancer Patient Fracture Evaluation study is the first randomized controlled trial comparing BKP with NSM for the treatment of VCFs in cancer patients.
Experience providing reliability
Our commitment is to consistently offer education and support programs to deepen clinician and patient awareness of VCF treatment options, expanding access to care in your community.
As your partner, we support you in procedures, cases, technical issues, reimbursement, and patient and medical education, and to provide ongoing clinical and economic evidence supporting balloon kyphoplasty for VCFs.
Medtronic pioneered balloon kyphoplast more than 20 years ago. Since then, we've treated more than 1.8 million fractures worldwide with VCFs.14
And we're not done yet.
Together, we can transform how vertebral compression fractutres are treated.
Start your journey with Medtronic today.
*
Kyphon Express™ II and Kyphon Xpander™ II IBTs have a maximum pressure rating of 700 psi and Kyphon Express™ and Kyphon Xpander™ first generation IBTs have a maximum pressure rating of 400 psi.
†
Prior to injection of cement, ensure volume of remaining IBT is reduced by 1.0cc. Balloon should not be in contact with the bone cement for more than 5 minutes.
References
1
Medtronic data on file. Kyphon Xpander™ II and Kyphon Express™ II inflatable bone tamps IFU M708348B326.
2
Compared to Kyphon™ bone filler device, when measured with dosimeters under fluoroscopy.Mean radiation reduction at the hands was reduced 77.79% (P < 0.001), based on internal testing of 24 total cadaveric procedures (Kyphon CDS: n=12; Kyphon™ bone filler device: n=12). Dosimeters placed on the wrist and fingers measured radiation while bone cement was delivered into the vertebral body. Radiation results are based on procedures as directed by the Directions For Use.
3
Medtronic data on file. Kyphon™ cement delivery system IFU M708348B358.
4
Medtronic data on file. ETR31101239.
5
Schils F, Schoojans W, Struelens L. The surgeon's real dose exposure during balloon kyphoplasty procedure and evaluation of the cement delivery system: a prospective study. Eur Spine J. 2013;22(8):1758-1764.
6
Medtronic internal report ETR 30004849/50/51 - 20/3 KYPHON Xpander™ IBT Design Verification Report
7
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.
8
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.
9
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.
10
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.
11
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
12
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.
13
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.
14
Medtronic data on file. Product marketing data; 2019.
15
Medtronic data on file; ETR 31002257, 2010. Material for Xpander compared to material for Xpander II, N=30 for each group, p<0.01. Bench testing may not be indicative of clinical results.
16
Medtronic internal report ETR 31101239 - Assessment of Kyphon Assist (Scoop) Cannula’s Directionality. Kyphon Assist compared to regular cannula, n =12 for each group. Bench testing may not be indicative of clinical results.
17
Ni W, Ricker C, Quinn M, Gasquet N, Janardhanan D, Gilligan CJ, Hirsch JA. Trends in opioid use following balloon kyphoplasty or vertebroplasty for the treatment of vertebral compression fractures. Osteoporos Int. 2022 Apr;33(4):821-837. doi: 10.1007/s00198-021-06163-3. Epub 2021 Nov 2. PMID: 34729624; PMCID: PMC8930950.
18
Ong KL, Beall DP, Frohbergh M, Lau E, Hirsch JA. 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. PubMed PMID: 29063215.
19
Edidin AA, Ong KL, Lau E, Kurtz SM. Morbidity and mortality after vertebral fractures: comparison of vertebral augmentation and non-operative management in the medicare population. Spine (Phila Pa 1976). 2015 Aug 1;40(15):1228–41. doi: 10.1097. PubMed PMID: 26020845.
20
Lange A, Kasperk C, Alvares L, Sauermann S, Braun S. Survival and cost comparison of kyphoplasty and percutaneous vertebroplasty using German claims data. Spine (Phila Pa 1976). 2014 Feb 15;39(4): 318–26. doi: 10.1097/ BRS.00000000000 00135. PubMed PMID: 24299715.
21
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 Oct 2;95(19):1729–36. doi: 10.2106/JBJS.K.01649. PubMed PMID: 24088964.
22
McCullough BJ, Comstock BA, Deyo RA, Kreuter W, Jarvik JG. Major medical outcomes with spinal augmentation vs. conservative therapy. JAMA Intern Med. 2013 Sep 9;173(16):1514–21. doi: 10.1001/jamainternmed.2013.8725. PubMed PMID: 23836009 ; PubMed Central PMCID: PMC4023124.
23
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 Jul;26(7):161726. doi: 10.1002/ jbmr.353. PubMed PMID: 21308780.
The material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s). Please note that the intended use of a product may vary depending on geographical approvals.
See the device manual(s) for detailed information regarding the intended use, the(implant)procedure, indications, contraindications, warnings, precautions, and potential adverse events.
For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI.
If a device is eligible for eIFU usage, instructions for use can be found at Medtronic’s website manuals.medtronic.com. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.
Medtronic products placed on European markets bear the CE mark and the UKCA mark (if applicable).
For any further information, contact your local Medtronic representative.