Medical Policy: 07.01.75
Original Effective Date: April 2017
Reviewed: April 2021
Revised: April 2021
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
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necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
These procedures involve the injection of a polymethylmethacrylate (PMMA), a cement, into a fractured or weakened vertebral body to provide stabilization as an alternative to spinal fusion. This stabilization of the structure provides immediate pain relief in many cases. Patients should be informed that there remains limited data evaluating vertebral augmentation in patients with chronic fractures and that pain may not improve after the procedure.
Percutaneous vertebroplasty, vertebral balloon kyphoplasty, and mechanical augmentation have been proposed as options to provide mechanical support and symptomatic pain relief in patients with osteoporotic vertebral compression, insufficiency fractures, vertebral hemangioma, or osteolytic lesions of the spine (i.e., multiple myeloma or metastatic malignancies). These procedures, kyphoplasty is sometimes referred to as vertebral augmentation, have been used in all levels of the spinal column including the sacrum and coccyx. When vertebroplasty or kyphoplasty is used to treat insufficiency fractures of the sacrum or coccyx they may be referred to as sacroplasty or coccygeoplasty.
Percutaneous vertebroplasty is an interventional radiology technique involving the fluoroscopic- or CT-guided injection of polymethylmethacrylate (PMMA) through a needle inserted into a weakened vertebral body.
Percutaneous kyphoplasty/vertebral augmentation is a variant of vertebroplasty that is intended to restore the vertebral body height and alignment along with stabilizing the fracture. Balloon kyphoplasty involves the use of a specialized bone tamp with an inflatable balloon to expand a collapsed vertebral body. PMMA is then injected into the created cavity to stabilize the vertebral body. Mechanical kyphoplasty describes techniques that do not involve a balloon device. In radiofrequency kyphoplasty, ultrahigh viscosity cement is injected into the fractured vertebral body. Radiofrequency energy is used to achieve the desired cement consistency. The ultrahigh viscosity cement is intended to restore height and alignment to the fractured vertebra, along with stabilizing the fracture. The Kiva® procedure uses shaped memory coil and a Kiva implant inserted into the vertebral body for structural support and to provide a reservoir for injection of bone cement. The proposed benefit of this technique is the adjustable height of the implant, which is made from a biocompatible polymer (e.g., PEEK-OPTIMA®), and a potential reduction in cement leakage. Vertebral body stenting utilizes an expandable scaffold instead of a balloon to restore vertebral height. The proposed advantages of vertebral body stenting are to reduce the risk of cement leakage by formation of a cavity for cement application and to prevent the loss of correction that is seen following removal of the balloon used for balloon kyphoplasty.
In an analysis of the National Inpatient Sample (NIS) database to determine trends in kyphoplasty and vertebroplasty, (2018) it was reported that vertebroplasty has been associated with retropulsion of cement into the spinal canal in up to 67% of cases. The NIS was developed for the Healthcare Cost and Utilization Project (HCUP) and constitutes the largest all-payer inpatient database in the United States. The database represents a 20% sample of discharges from U.S. hospitals (excluding rehabilitation and long-term acute care hospitals), which is weighted to provide national estimates. Further prospective randomized trials are necessary to more rigorously evaluate the long-term outcomes and cost-effectiveness of kyphoplasty versus vertebroplasty from a national healthcare perspective.
Spineoplasty is a new minimally invasive procedure similar to vertebroplasty currently being researched. The procedure includes a graft consisting of mesh filled with bone chips instead of the traditional cement used to fix a fracture. The OptiMesh® 1500E is a Polyethylene Terephthalate (PET) mesh pouch designed to contain impacted granular bone chips and allows it to be deployed to the area needing repair. This mesh graft is used most commonly for traumatic fracture repair and interbody fusion. This graft has not received FDA approval for this use.
Radiofrequency Vertebral Augmentation
The StabiliT® Vertebral Augmentation System is an osteotomy and bone cement delivery system intended to relieve pain and stabilize the spine in patients with vertebral compression fractures (VCFs) while minimizing the risk of cement extravasation during the procedure (a concern with conventional balloon kyphoplasty [BKP]). The system uses radiofrequency kyphoplasty (RFK) to repair the vertebra by controlled injection of StabiliT ER2 ultraviscous bone cement without the need for a balloon. This report focuses on how patient outcomes after StabiliT vertebral augmentation compare with outcomes after conventional vertebral BKP.
RFK (also known as radiofrequency-targeted vertebral augmentation) with the StabiliT system is a procedure intended as an alternative to BKP. In RFK, a surgeon uses a navigational cannula to create small pathways in the vertebra before injecting a proprietary ultraviscous bone cement, StabiliT ER2 Bone Cement. The surgeon uses radiofrequency heating (23°C) pulses to control the cement's viscosity during injection; this in turn allows the surgeon to restore the vertebra's height with the injection alone, without the need for a balloon. The RFK procedure is also intended to preserve healthy tissue by creating smaller pathways in the vertebra than traditional BKP, reduce cement leak risks, and reduce procedure time. The StabiliT system consists of a radiofrequency warming source, an introducer, and a flexible-tip PowerCurve® Navigating Osteotome. The StabiliT ER2 Bone Cement is made of polymethyl methacrylate and is available in two separate components (a colorless liquid and a fine powder) that the surgeon mixes immediately before injection. The cement polymerizes as it passes through the radiofrequency heater. The system is available in different kit configurations, including StabiliT Vertebral Augmentation System, the StabiliT MX Vertebral Augmentation System, and the StabiliT VP Vertebroplasty System.
Practice Guidelines and Position Statements
The American Academy of Orthopedic Surgeons (AAOS) published a clinical practice guideline and evidence report on the treatment of symptomatic osteoporotic spinal compression fractures in 2010:
- We recommend against vertebroplasty for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact.
- Kyphoplasty is an option for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact. They also downgraded the recommendation supporting the use of kyphoplasty from “moderate” to “limited” based upon low quality and inconclusive evidence comparing this procedure with conservative care and vertebroplasty, respectively.
Additional AAOS recommendations regarding treatment of osteoporotic compression fractures include:
- We suggest patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms suggesting an acute injury (0-5 days after identifiable event or onset of symptoms) and who are neurologically intact be treated with calcitonin for 4 weeks. (Strength of recommendation: moderate)
- Ibandronate and strontium ranelate are options to prevent additional symptomatic fractures in patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms. (Strength of recommendation: weak)
Joint Guideline (AANS, CNS, ACR, ASNR, ASSR, CIRA and the SNIS)
A practice guideline for the performance of vertebral augmentation (including vertebroplasty and kyphoplasty) developed in collaboration by the American College of Radiology (ACR), American Society of Neuroradiology (ASNR), Society of Neurointerventional Surgery (SNIS), American Society of Spine Radiology (ASSR), and the Society of Interventional Radiology (SIR), was amended in 2014 (AANS, CNS, ACR, ASNR, ASSR, CIRA, and the SNIS, 2014).
The guideline states that the major indication for vertebroplasty is the treatment of symptomatic osteoporotic vertebral body compression fracture(s) refractory to medical therapy or vertebral bodies weakened due to neoplasia. Failure of medical therapy is defined as follows:
- For a patient rendered nonambulatory due to pain from weakened or fractured vertebral body, pain persisting at a level that prevents ambulation despite 24 hours of analgesic therapy.
- For a patient with sufficient pain from weakened or fractured vertebral body that physical therapy is intolerable, pain persisting at that level despite 24 hours of analgesic therapy.
- For any patient with weakened or fractured vertebral body, unacceptable side effects such as excessive sedation, confusion, or constipation due to the analgesic therapy necessary to reduce pain to a tolerable level.
The guideline includes the following indications for vertebral augmentation:
- Painful osteoporotic vertebral compression fracture(s) refractory to medical therapy
- Vertebral bodies weakened by neoplasm
- Symptomatic vertebral body microfracture (as documented by magnetic resonance imaging [MRI] or nuclear imaging, and/or lytic lesion seen on CT) without obvious loss of vertebral body height.
American Association of Clinical Endocrinologists (AACE)/American College of Endocrinology (ACE)
In a clinical practice guideline for the diagnosis and treatment of postmenopausal osteoporosis, the AACE and ACE (2016) do not recommend vertebroplasty and kyphoplasty as first-line treatment of vertebral fractures given the unclear benefit on overall pain and the potential increased risk of vertebral fractures in adjacent vertebrae (Grade B, BEL 1; downgraded due to limitations of published studies).
American Society of Bone and Mineral Research (ASBMR)
In a review of pain, quality of life and safety outcomes of balloon kyphoplasty compared to other surgical techniques and non-surgical management for vertebral compression fractures (VCF), the ASBMR evaluated ten unique trials (1,837 participants). Balloon kyphoplasty in comparison to non-surgical management, was associated with greater reductions in pain, back-related disability, and better quality of life that appeared to lessen over time but were less than minimally clinically important differences. Risk of new VCF at 3 and 12 months was not significantly different. Individuals with painful VCF experienced symptomatic improvement compared with baseline with all interventions. There were no significant differences between balloon kyphoplasty and percutaneous vertebroplasty in back pain, back disability, quality of life, risk of new VCF or any adverse events. Limitations of the studies included lack of a balloon kyphoplasty versus sham comparison, availability of only one randomized controlled trial of balloon kyphoplasty versus non-surgical management, and lack of study blinding. The authors noted that the clinical importance of the greater improvements with balloon kyphoplasty versus non-surgical management is unclear, may be due to placebo effect, and may not counterbalance short-term adverse event risks. Outcomes appeared similar between balloon kyphoplasty and other surgical interventions. The ASMBR recommends well-conducted randomized trials comparing balloon kyphoplasty with sham to help resolve remaining uncertainty about the relative benefits and harms of this procedure. (2017)
Kyphoplasty and Vertebral Augmentation Devices and Bone Cement Cleared by the U.S. Food and Drug Administration
- Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)-Stryker Corporation
- SpineJack Expansion Kit-Vexim SA
- SpineKure Kyphoplasty System-Hanchang Co. Ltd.
- KYPHON HV-R Bone Cement-Medtronic Sofamor Danek USA Inc.
- Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters G-21 s.r.l.
- 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)Pan Medical Ltd.
- Kyphon HV-R Bone Cement- MEDTRONIC INC
- MEDINAUT Kyphoplasty System-IMEDICOM Co. Ltd.
- OSTEOPAL plus-HERAEUS MEDICAL GMBH
- AVAflex Vertebral Balloon System-CAREFUSION
- Osseoflex SB Straight Balloon 10g/4ml Osseoflex SB Straight Balloon 10g/2ml-OSSEON LLC
- InterV Kyphoplasty Catheter (Balloon Length: 1015 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10 15 and 20mm)-PAN MEDICAL LTD
- GUARDIAN-SG Inflatable Bone Expander System-BM KOREA CO. LTD.
- ZVPLASTY-ZAVATION LLC
- KIVA VCF TREATMENT SYSTEM-BENVENUE MEDICAL INC.
- V-Strut Vertebral Implant- Hyprevention SAS
The use of PMMA in sacroplasty is an off-label use of an FDA-regulated product (bone cements such as Spine-Fix® Biomimetic Bone Cement [Teknimed] and Osteopal® V [Heraeus]) because the 510(k) approval was for the fixation of pathologic fractures of the vertebral body using vertebroplasty procedures. Sacroplasty was not included.
Percutaneous vertebroplasty, percutaneous balloon or mechanical kyphoplasty, may be considered medically necessary for treatment of no more than 3 symptomatic fractures of the T5-L5 spine. When the fractures are due to the following conditions:
- Multiple myeloma or
- Osteoporotic/osteolytic compression fractures, unresponsive to conservative therapy of at least 6 weeks treatment (e.g., analgesics, physical therapy, rest) or
- Malignant neoplasm of the bone or bone marrow or
- Kümmell's disease (presents as vertebral osteonecrosis typically affecting a thoracic vertebra with compression deformity, intravertebral vacuum cleft, and exaggerated kyphosis weeks to months after a minor traumatic injury.)
Additionally, all of the following criteria must be met:
- Appropriate imaging (plain film x-ray, MRI, CT, or bone scan) has been performed preoperatively and the findings of such imaging correlate unequivocally with the patient’s pain; and
- It has been established in the clinical record that the patient’s pain is predominantly, if not solely, related to the demonstrated fracture(s); and
- The fracture is recent (less than 6 months) and
- Functional impairment attributed to vertebral fracture is documented in the clinical record as limiting performance of instrumental activities of daily living (ADLs). Instrumental ADLs are defined as feeding, bathing, dressing, grooming, meal preparation, household chores, and occupational tasks that are required as a daily part of job functioning and
- A pre-procedure assessment has documented the absence of all of the following contraindications:
- Untreated symptomatic foraminal or canal stenosis, facet arthropathy, or other significant coexistent spinal or bony pain generators at the planned treatment level
- Symptoms that cannot be related to the fracture or metastatic disease
- Unstable fracture or requirement for stabilization procedure in same or adjacent spinal region
- Active osteomyelitis whether fungal, bacterial or mycobacterial, or any other active infection, including urinary tract infection (UTI)
- Uncorrected coagulation disorders
- Known allergy to any of the materials used in these procedures
- Chronic (>6 months) fracture at the same vertebral level
- When the vertebral body fracture is associated with widened pedicles or retropulsion of bone as in a burst fracture.
- Significant vertebral collapse (i.e., vertebra reduced to less than one-third [l/3] of its original height)
Percutaneous vertebroplasty or kyphoplasty are considered investigational for all other indications, including but not limited to the following:
- Acute vertebral fractures due to trauma, without previous conservative therapy
- Vertebral hemangioma
- Vertebrae of the cervical spine and thoracic levels T1-4
- Stabilization of insufficiency fractures or lesions of the sacrum (sacroplasty) or coccyx (coccygeoplasty)
- Prophylactic treatment for osteoporosis of the spine or for chronic back pain of long-standing duration (>6 months), even if associated with old compression fracture(s).
Radiofrequency Kyphoplasty/Radiofrequency-Assisted Vertebral Augmentation
Radiofrequency-assisted vertebral augmentation with ultrahigh viscosity cement, including but not limited to Radiofrequency-Targeted Vertebral Augmentation™ (RF-TVA™) with the StabiliT® System is considered investigational.
Vertebral Body Stenting
Vertebral body stenting is considerd investigational.
For treatment of vertebral body fractures related to osteoporosis or malignancy with percutaneous vertebroplasty, balloon kyphoplasty, or Kiva, the primary beneficial outcomes of interest are relief of pain and improvement in ability to function. Both of these outcomes can be influenced by nonspecific effects, placebo response, and natural history of the disease. Therefore, data from large, blinded, randomized controlled trials (RCTs) of sufficient long-term follow-up are required to control for the placebo effect, determine its magnitude, and determine whether any treatment effect from vertebroplasty or kyphoplasty provides a significant advantage over sham or nonsurgical treatment. Further, adverse effects related to complications from percutaneous vertebroplasty or kyphoplasty, such as risk of additional fractures or cement leakage, must be considered in evaluating the net health impact of these technologies.
The current evidence for mechanical vertebral augmentation using techniques other than balloon kyphoplasty (e.g., radiofrequency-assisted vertebral augmentation, vertebral body stenting) is limited to preliminary randomized trials. Two widely discussed recent studies comparing vertebroplasty to sham procedures demonstrated no significant improvement with vertebroplasty. This mixed evidence has sparked considerable debate as to the appropriate role of this procedure. Vertebral body stents have not received approval/clearance by the FDA at this time. In addition, there are no clinical practice guidelines from U.S. professional societies that recommend these techniques.
Percutaneous sacroplasty is considered investigational for all indications, including use in sacral insufficiency fractures due to osteoporosis and sacral lesions due to metastatic malignancies or multiple myeloma.
Spineoplasty as a treatment of fracture repair is considered investigational.
This procedure includes a graft consisting of mesh filled with bone chips instead of the traditional cement used to fix a fracture. This graft has not received FDA approval for this use. The spinoplasty procedure has yet to show efficacy and durability on net health outcomes.
Procedure Codes and Billing Guidelines:
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.
- 22510 Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; cervicothoracic
- 22511 Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; lumbosacral
- 22512 Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; each additional cervicothoracic or lumbosacral vertebral body (List separately in addition to code for primary procedure
- 22513 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; thoracic
- 22514 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; lumbar
- 22515 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; each additional thoracic or lumbar vertebral body (List separately in addition to code for primary procedure)
- 22899 Unlisted procedure, spine (deny for spinoplasty or vertebral body stenting)
- 29999 Unlisted procedure, arthroscopy (deny for spinoplasty or vertebral body stenting)
- 0200T Percutaneous sacral augmentation (sacroplasty), unilateral injection(s), including the use of a balloon or mechanical device, when used, 1 or more needles, includes imaging guidance and bone biopsy, when performed
- 0201T Percutaneous sacral augmentation (sacroplasty), bilateral injections, including the use of a balloon or mechanical device, when used, 2 or more needles, includes imaging guidance and bone biopsy, when performed
- C1062 Intravertebral body fracture augmentation with implant (e.g., metal, polymer)
- Blue Cross and Blue Shield Technology Evaluation Center (TEC). Percutaneous vertebroplasty for vertebral fractures caused by osteoporosis. TEC Assessments. 2010;Volume 25, Tab 9.
- Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. Aug 6 2009;361(6):557-568. PMID 19657121
- Staples MP, Kallmes DF, Comstock BA, et al. Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis. BMJ. 2011;343:d3952. PMID 21750078
- Chen D, An ZQ, Song S, et al. Percutaneous vertebroplasty compared with conservative treatment in patients with chronic painful osteoporotic spinal fractures. J Clin Neurosci. Mar 2014;21(3):473-477. PMID 24315046
- Wang LJ, Yang HL, Shi YX, et al. Pulmonary cement embolism associated with percutaneous vertebroplasty or kyphoplasty: a systematic review. Orthop Surg. Aug 2012;4(3):182-189. PMID 22927153
- ACR-ASNR-ASSR=SIR-SNIS. Practice guideline for the performance of vertebral augmentation 2012.
- Barr JD, Jensen ME, Hirsch JA, et al. Position statement on percutaneous vertebral augmentation: a consensus statement developed by the Society of Interventional Radiology (SIR), American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), American College of Radiology (ACR), American Society of Neuroradiology (ASNR), American Society of Spine Radiology (ASSR), Canadian Interventional Radiology Association (CIRA), and the Society of NeuroInterventional Surgery (SNIS). J Vasc Interv Radiol. Feb 2014;25(2):171-181. PMID 24325929
- American College of Radiology. Management of Compression Fractures. 2013.
- American Academy of Orthopaedic Surgeons (AAOS). Clinical Practice Guideline Treatment of osteoporotic spinal compression fractures. 2010.
- National Institute for Health and Care Excellence (NICE). IPG 12: Percutaneous Vertebroplasty. 2003.
- National Institute for Health and Care Excellence (NICE). TA 279 Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures. 2013.
- ECRI Institute, Health Technology Assessment, StabiliT vertebral augmentation system (Dfine, Inc.) for treating vertebral fractures. June 2016.
- ECRI Institute, Health Technology Assessment, Overview of four selected balloon kyphoplasty and vertebral augmentation systems. November 2015.
- Rodriguez AJ, Fink HA, Mirigian L, et al. Pain, quality of life and safety outcomes of kyphoplasty for vertebral compression fractures: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2017 May 17. [Epub ahead of print]
- Bae H, Hatten HP, Jr., Linovitz R, et al. A prospective randomized FDA-IDE trial comparing Cortoss with PMMA for vertebroplasty: a comparative effectiveness research study with 24-month follow-up. Spine (Phila Pa 1976). Apr 01 2012;37(7):544-550. PMID
- Yang EZ, Xu JG, Huang GZ, et al. Percutaneous Vertebroplasty versus conservative treatment in aged patients with acute osteoporotic vertebral compression fractures: a prospective randomized controlled clinical study. Spine (Phila Pa 1976). Apr 2016;41(8):653-660. PMID 26630417
- Leali PT, Solla F, Maestretti G, et al. Safety and efficacy of vertebroplasty in the treatment of osteoporotic vertebral compression fractures: a prospective multicenter international randomized controlled study. Clin Cases Miner Bone Metab. Sep-Dec 2016;13(3):234-236. PMID 28228788
- Tsoumakidou G, Too CW, Koch G, et al. CIRSE Guidelines on Percutaneous Vertebral Augmentation. Cardiovasc Intervent Radiol 2017;40:331–42
- Chandra RV, Meyers PM, Hirsch JA, et al; Society of NeuroInterventional Surgery. Vertebral Augmentation: report of the Standards and Guidelines Committee of the Society of NeuroInterventional Surgery. J Neurointerv Surg 2014;6:7–15
- Barr JD, Jensen ME, Hirsch JA, et al. Position statement on percutaneous vertebral augmentation: a consensus statement developed by the Society of Interventional Radiology (SIR), American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), American College of Radiology (ACR), American Society of Neuroradiology (ASNR), American Society of Spine Radiology (ASSR), Canadian Interventional Radiology Association (CIRA), and the Society of euroInterventional Surgery (SNIS). J Vasc Interv Radiol 2014;25: 171– 81
- Beall D, Coe J, McIlduff M, et al. Serious adverse events associated with readmission through one year after vertebral augmentation with either a polyetheretherketone implant or balloon kyphoplasty. Follow-up analysis of the KAST randomized controlled trial comparing the Kiva Vertebral Compression Fracture Treatment System. Pain Physician. 2017;20:521-528.
- UpToDate, Inc. Evaluation and management of complete and impending pathologic fractures in patients with metastatic bone disease, multiple myeloma and lymphoma. Updated June 2018.
- ECRI Institute. Kyphon Balloon Kyphoplasty (Medtronic, plc) for Treating Vertebral Fractures. Plymouth Meeting (PA): ECRI Institute; 2019 Oct 10. (Custom Product Brief).
- ECRI Institute. SpineJack Implantable Fracture Reduction System (Vexim SA) for Treating Vertebral Compression Fractures. Plymouth Meeting (PA): ECRI Institute; 2019 May 01. (Custom Product Brief).
- Treatment for Acute Pain: An Evidence Map Technical Brief Number 33 AHRQ Publication No. 19(20)-EHC022-EF October 2019
- Regulatory Status FDA granted 510(k) marketing clearance for the SpineJack system in August 2018 under the trade name SpineJack Expansion Kit (K181262). The primary predicate device is listed as the Kiva VCF (vertebral compression fracture) Treatment System (K132817), for which FDA granted 510(k) marketing clearance in January 2014.
- ECRI Institute. StabiliT Vertebral Augmentation System (Merit Medical, Inc.) for Treating Vertebral Fractures. Plymouth Meeting (PA): ECRI Institute; 2020 Jan 16. (Custom Product Brief).
- Sorensen ST, Kirkegaard AO, Carreon L, et al. Vertebroplasty or kyphoplasty as palliative treatment for cancer-related vertebral compression fractures: a systematic review. Spine J. 2019 Jun;19(6):1067-1075.
- Liu Q, Cao J, Kong JJ. Clinical effect of balloon kyphoplasty in elderly patients with multiple osteoporotic vertebral fractures. Niger J Clin Pract. 2019 Mar;22(3):289-292.
- Noriega DC, RodrÎ¯guez-Monsalve F, Ramajo R, et al. Long-term safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study. Osteoporos Int. 2019 Mar;30(3):637-645.
- Chang, J., Bei, M., Shu, D. et al. Comparison of the clinical outcomes of percutaneous vertebroplasty vs. kyphoplasty for the treatment of osteoporotic Kümmell’s disease:a prospective cohort study. BMC Musculoskelet Disord 21, 238 (2020).
- ECRI Institute. StabiliT Vertebral Augmentation System (Merit Medical, Inc.) for Treating Vertebral Fractures. Plymouth Meeting (PA): ECRI Institute; 2020 Jan 16. (Custom Product Brief).
- ECRI. SpineJack Implantable Fracture Reduction System (Vexim SA) for Treating Vertebral Compression Fractures. Plymouth Meeting (PA): ECRI; 2020 Oct 12. (Clinical Evidence Assessment).
- April 2021 - Annual Review, Policy Revised
- June 2020 - Interim Review, Policy Revised
- April 2020 - Annual Review, Policy Revised
- April 2019 - Annual Review, Policy Revised
- April 2018 - Annual Review, Policy Revised
- April 2017 - New Policy
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