It does not constitute legal advice or a recommendation regarding clinical practice. After reduction, the balloons are deflated and removed. Besides conventional vertebral cement augmentation techniques balloon kyphoplasty has become a popular tool to address painful thoracic and lumbar. All patients identified had a kyphoplasty performed by unipedicular, bipedicular or extrapedicular approach depending upon surgeon preference. Balloon kyphoplasty procedure including information about reimbursement and uplifting patient testimonials. Feb 21, 2011 vertebroplasty is a minimally invasive, nonsurgical therapy used to strengthen a spinal bone vertebra that has been weakened or broken by osteoporosis or, less commonly, cancer. Percutaneous balloon kyphoplasty or mechanical vertebral augmentation. Other factors to consider before deciding on kyphoplasty also exist, such as whether the patient is healthy enough for surgery. Balloon kyphoplasty for vertebral compression fractures. Comparison of 5766 vertebral compression fractures treated with or without kyphoplasty.
Kyphon balloon kyphoplasty is a minimally invasive procedure that can repair spinal fractures. In 2005, health canada licensed kyphx inflatable bone tamp kyphon inc. Corporate medical policy vertebroplasty, kyphoplasty, and. Balloon kyphoplasty as a treatment for vertebral compression fractures a technology assessment. Aim of this paper is to give an overview of the state of the art about.
It takes about an hour per fracture level to treat a fracture with balloon kyphoplasty, and the procedure can be done on an outpatient or inpatient basis. Information for clinicians about balloon kyphoplasty, a minimally invasive procedure for reducing and stabilizing vertebral compression fractures vcfs. Percutaneous balloon kyphoplasty, radiofrequency kyphoplasty rfk, and mechanical vertebral augmentation with kiva are interventional techniques involving the fluoroscopically guided injection of polymethylmethacrylate pmma into a cavity created in the vertebral body with a balloon or mechanical device. Apr 19, 2011 balloon kyphoplasty step by step procedure guide 1. Subsequently, other products such as spinefix biomimetic bone cement, kyphon hvr bone cement, and osteopal v heraeus have received 510k marketing clearance for the fixation of pathologic fractures of. However, rf kyphoplasty is a new method which controls cement. This trial compares the efficacy and safety of balloon kyphoplasty and vertebroplasty. To help you pick the right option and know the risks, here is a post about vertebroplasty vs kyphoplasty. Subsequent models received fda 510k clearance in 2001 and 2003. Kyphoplasty patientcentered outcomes via questionnaire. Technology assessment series are freely available in pdf format at the.
In a study comparing balloon kyphoplasty with conventional medical care, midline vertebral body height was significantly increased in the balloon kyphoplasty group compared with that at baseline and at 12 months was significantly greater than in the controls 67% vs 56%. The following presentation will walk you through this minimally invasive procedure step by step. Clinical and radiographic results of kyphoplasty with mid. The complication rate with kyphon balloon kyphoplasty has been demonstrated to be low. Balloon kyphoplasty for spinal fractures medtronic. Kyphon, the manufacturer of the inflatable bone tamps has stated that the. Original article biomechanics characteristic of shape memory alloy expandable vertebrae stents smaevs and kyphon baloon in spine surgery xiaoyong liu1,2, huilin yang1, zongping luo3, wen zhang3, tiansi tang1 1department of orthopedics, the first affiliated hospital of soochow university, soochow, jiangsu, china. It is sometimes compared to another vertebral augmentation procedure called vertebroplasty, which may also be performed using minimally invasive techniques. Information for clinicians about balloon kyphoplasty, a minimally invasive procedure for reducing and stabilizing. Kaiser foundation health plan of washington and kaiser foundation health plan of washington options, inc. Health canada has licensed kyphx xpander inflatable bone tamp kyphon inc.
Vertebral augmentation, which includes vertebroplasty and kyphoplasty, are similar spinal procedures in which bone cement is injected through a small hole in the skin into a fractured vertebra to try to relieve back pain caused by a vertebral compression fractures. Balloon kyphoplasty is a modified vertebroplasty technique. This guidance replaces previous guidance on balloon kyphoplasty for vertebral compression fractures interventional procedures guidance no. Vertebroplasty and balloon kyphoplasty are established procedures for the treatment of osteoporotic vcfs. Clinical orthopaedics and related research, july 2010 kyphoplasty reduces pain and improves mobility as long as 3 years after the procedure. Kyphon hvr bone cement medtronic sofamor danek usa inc. Percutaneous vertebroplasty and balloon kyphoplasty kce. Neither vertebroplasty nor percutaneous vertebral augmentation is. There are risks associated with the procedure, including serious complications, and though rare, some of which may be fatal.
Ontario and saskatchewan are the two canadian provinces providing reimbursement for kyphoplasty. Balloon kyphoplasty is a minimally invasive surgical procedure performed to treat one or more vertebral compression fractures vcfs. Medtronickyphon, the 800pound gorilla of kyphoplasty. Kyphon balloon kyphoplasty uses orthopaedic balloons to restore vertebral height and correct angular deformity from vertebral compression fractures vcf due to osteoporisis, cancer, or benign lesion. Spine surgeons debate the value of vertebroplasty and kyphoplasty. Balloon kyphoplasty is a minimally invasive treatment for spinal compression fractures also called vertebral compression fractures of vcfs. Pdf kyphoplasty in osteoporotic vertebral compression fractures. All kyphoplasties were performing using kyphon balloon kyphoplasty medtronic, memphis, tn. See how the kyphon balloon kyphoplasty and cement delivery system are used to administer the. A02a kyphon osteo introducer system for precise access to the vertebral body. See how the kyphon balloon kyphoplasty and cement delivery system are used to administer the balloon kyphoplasty procedure for vertebral compression fractures. Spinal fractures osteoporosis causes more than 700,000 spinal fractures each year in the u. Patients were seen in clinic after the procedure at least twice within the first year.
We compared the efficacy and safety of balloon kyphoplasty to nonsurgical therapy over 24 months in patients with acute painful fractures. Balloon kyphoplasty ontario health technology assessment series 2004. There was no statistically significant difference in the number of patients with new radiographic fractures between the groups at 24 months. Each year, 700,000 people in the united states will suffer compression fractures of the spine due to osteopo. The resulting cavity void allows for a controlled deposition of kyphon bone cement which helps form an internal cast. Postoperatively, patients were not braced and had no physical restrictions. Jun 19, 2009 kyphoplasty, vertebroplasty kyphon kyph, houston more on osteoporosis. Spinal fractures and kyphon balloon kyphoplasty treatment. Patients treated with kyphon balloon kyphoplasty showed no additional risk of subsequent fractures vs.
Download technical manuals for kyphon products from the medtronic manual library. Vertebroplasty is a minimally invasive, nonsurgical therapy used to strengthen a spinal bone vertebra that has been weakened or broken by osteoporosis or, less commonly, cancer. How the balloon works kyphon balloon kyphoplasty is a minimally invasive treatment in which orthopedic balloons are used to gently elevate the fractured vertebra in an attempt to return it to the correct position. Osteoporotic compression fractures of the spine thoracic and lumbar can be very painful. Learn about the kyphon balloon kyphoplasty procedure and products. Important safety information for kyphon balloon kyphoplasty the complication rate for kyphon balloon kyphoplasty has been demonstrated to be low.
The surgical system is marketed by kyphon which has recently become part of medtronic inc. A08e kyphon latitude ii curette for scraping bone in the vertebral body, increasing inflatable bone tamp efficiency. Jul 22, 2015 watch a television ad for kyphon balloon kyphoplasty procedure for spinal fractures. Spine surgeons debate the value of vertebroplasty and. Kyphon balloon kyphoplasty is a minimally invasive treatment that can stabilize the fracture and reduce back pain, as well as restore vertebral body height and. Jan 21, 2006 the aim of this study is to evaluate the efficacy and safety of balloon kyphoplasty bk in the management of vertebral compression fractures vcfs. Balloon kyphoplasty procedure reimbursement guide effective january 2020 medtronic provides this information for your convenience only. Original article biomechanics characteristic of shape memory. In the uk the national institute for clinical excellence and health has evaluated the technique and issued the following appraisal and. Patients suffering from vcf have two treatment options vertebroplasty vp and kyphoplasty kp. Quick coding tips for vertebroplasty and kyphoplasty aapc.
Medtronic data on file kyphon express ii inflatable bone tamps. Pdf vertebral fractures are a major health care problem in western countries. Stepbystep you have been diagnosed with a vertebral compression fracture. If you have a compression fracture of the spine, kyphoplasty is a procedure that might help relieve pain and improve mobility when other measures fail to provide relief. L0015 balloon kyphoplasty for vertebral compression fractures. For more details, refer to the sources of evidence.
Spinal fractures kyphon balloon kyphoplasty treatment. Vertebral compression fractures that occurred more than 3 months prior to surgery have already started to heal and are unlikely to experience the vertebral height restoration normally associated with kyphoplasty. A randomized trial comparing balloon kyphoplasty and. Important safety information is shown at the end of the video. Carefusion, a recent spinoff from health care giant cardinal health.
All kyphoplasty was performed using the kyphon balloon kyphoplasty system medtronic spine, llc, sunnyvale, ca, usa. Kyphon balloon kyphoplasty treating spinal fractures aims to make it easier for patients to return to everyday activities with significantly less pain than they had prior to the procedure. Adults with one to three vertebral fractures were randomized within 3 months from onset of pain to undergo kyphoplasty n 149 or nonsurgical therapy n 151. Patients were sent home the same day if no complications occurred. The kyphon inflatable bone tamp kyphon, santa clara, ca first received fda 510ki clearance in 1998. Percutaneous balloon kyphoplasty, radiofrequency kyphoplasty rfk, and mechanical.
You can file a grievance in person or by mail, fax, or email. Efficacy and safety of balloon kyphoplasty in the treatment. Mp114vertebroplasty and percutaneous kyphoplasty geisinger. The following corporate literature is appended in pdf files below. Vertebral augmentation percutaneous kyphoplasty amazon s3. The longterm risk of new vertebral fractures after kyphoplasty was. Studies report favorable patient outcomes after a kyphon balloon kyphoplasty procedure versus nonsurgical treatment 4,5, such as. Jun 27, 2016 kyphoplasty is like vertebroplasty plus percutaneous vertebral augmentation a. Balloon kyphoplasty for the treatment of acute vertebral. Both are mildly invasive and effective, but they also have their differences. Balloon kyphoplasty overview for physicians, kyphon medical. Your doctor may use imaging guidance to inject a cement mixture into the fractured bone vertebroplasty or insert a balloon into the fractured bone.
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