Description ga 10ga 11ga ga 11ga ga 11ga ga ga 15ga kits vpk1002 kyphon v osteo introducer 10ga trocar kit 1 1 2 vpk011d kyphon v osteo introducer 11ga trocarbevel kit 1 1 1 2 vpk011b kyphon v osteo introducer 11ga bevel kit 1 1 2 vpk0d kyphon v osteo introducer ga trocarbevel kit 1 1 1 2 vpk0b kyphon v osteo introducer. Early and effective treatment fixing the broken bone may reduce the consequences of spinal fractures, especially those associated with other treatments, for example, prolonged. Balloon kyphoplasty for spinal fractures medtronic. Kyphoplasty is low, as with most surgical procedures, serious adverse events, some of which can be fatal. Television ad for kyphon balloon kyphoplasty youtube. Percutaneous vertebroplasty and percutaneous balloon. Unlike traditional balloon kyphoplasty, structural kyphoplasty allows for physiciancontrolled fracture reduction. These pieces are available on the hospital marketing kit cd in the folder titled fact sheets. Kyphoplasty is a type of surgery that stabilizes a vertebra a bone of the. See five key studies that demonstrate efficacy of kyphon balloon kyphoplasty for vcf.
The resulting cavity void allows for a controlled deposition of kyphon bone cement which helps form an internal cast. As a surgical procedure, balloon kyphoplasty is not subject to fda clearance. In the absence of benefit mandates that govern the service, procedure or treatment, or when the members eoc document is. The system, an upgrade to the popular kyphon xpander ibt, is used for treatment of vertebral compression fractures via the companys proprietary kyphon balloon kyphoplasty procedure. Marketing your practice is an important part of ensuring that patients are aware of and have. Patient found to have a 30% right lung pneumothorax in the post anesthesia recovery room discovered on x. Balloon kyphoplasty procedure including information about reimbursement and uplifting patient testimonials. The powder component consists of a pmma copolymer polymethyl.
New directional cannula provides more flexibility and. Kyphoplasty aims to reduce pain and curvature of the spine. Important safety information is shown at the end of the. The staxx fx structural kyphoplasty system is a novel device to be used in kyphoplasty procedures.
Medtronic kyphon, the 800pound gorilla of kyphoplasty. For complete information regarding indications for use, contraindications, warnings, precautions. Download the balloon kyphoplasty pdf document here. Watch a television ad for kyphon balloon kyphoplasty procedure for spinal fractures.
Vertebral augmentation percutaneous kyphoplasty amazon s3. 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. Percutaneous balloon kyphoplasty, radiofrequency 6. Final appraisal determination percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures issue date. Kyphoplasty was thought to have lesser adjacent fractures due to correction of kyphotic deformity, but kyphosis is not the only reason for adjacent fractures. Carefusion, a recent spinoff from health care giant cardinal health. However, there remains a risk of bone cement leakage during and after kyphoplasty, especially in cases characterized by vertebral wall destruction. Medical management of vertebral body fractures includes analgesics, bed rest, and external bracing. Kyphoplasty side effects doctors answer your questions. The surgical system is marketed by kyphon which has recently become part of medtronic inc. Kyphoplasty of vertebral fractures with kyphos bone. 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. Percutaneous vertebroplasty, kyphoplasty, and sacroplasty page 1 of 3 policy name. Stepbystep you have been diagnosed with a vertebral compression fracture.
Kyphoplasty of vertebral fractures with kyphos bone poster no c2400. Medinaut kyphoplasty system 510k summary apr 0 4 2914. The following presentation will walk you through this minimally invasive procedure step by step. Kyphoplasty system an overview sciencedirect topics. This prototype edition of the daily federal register on federalregister. The kyphon balloon kyphoplasty platform is used to repair vertebral compression fractures vcfs by reducing and stabilizing the fractures. Download technical manuals for kyphon products from the medtronic manual library. The kyphon assist directional cannula is compatible across the medtronic portfolio of balloon kyphoplasty products, including the kyphon xpander ii inflatable bone tamps. Learn about the kyphon balloon kyphoplasty procedure and products. L0015 balloon kyphoplasty for vertebral compression. Kyphon, the manufacturer of the inflatable bone tamps has stated that the. Although the complication rate for kyphon balloon kyphoplasty is low, as with most.
The grohs study compared kyphoplasty head to head with vertebroplasty however, it was small, nonrandomized and unblinded. Kyphoplasty is an excellent treatment for patients with osteoporotic compression fractures that are failing conservative care or are in debilitating pain. Kyphon balloon kyphoplasty can reduce or eliminate your back pain from a spinal fracture, as well as restore vertebral body height and proper alignment of your spine. Kyphoplasty tool kit consists of puncture device, puncture expandor device, expandor device, bone cement filling device, bone drill and. Your doctor may use imaging guidance to inject a cement mixture into the fractured bone vertebroplasty or insert a balloon into the fractured bone. Balloon kyphoplasty if you have been diagnosed with a spinal fracturevertebral compression fracture vcf caused by osteoporosis, cancer or benign tumors, balloon kyphoplasty may be a treatment option. However, an inflatable bone tamp is required to perform the surgery. Allows for directional control of inflatable bone tamps during a balloon kyphoplasty procedure additional height restoration in a.
Kyphoplasty is a surgical procedure and, as such, is not subject to regulation by the u. It is also successful in the treatment of pathologic features from certain metastatic tumors and multiple myeloma. 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. Kyphon hvr bone cement medtronic sofamor danek usa inc. Kyphoplasty is a minimally invasive procedure used to treat vertebral compression fractures, which primarily occur in elderly patients with osteoporosis. The following corporate literature is appended in pdf files below. Medtronic launches kyphon xpander ii ibt system medgadget. Attachment a supporting document that is developed and maintained by the policy writer or department requiringauthoring the policy. Vertebral augmentation percutaneous kyphoplasty policy. Pdf kyphoplasty in osteoporotic vertebral compression fractures. Complications and safety aspects of kyphoplasty for. Kyphoplasty is a variation of a vertebroplasty which attempts to restore the height and angle of kyphosis of a fractured vertebra of certain types, followed by its stabilization using injected bone cement.
Balloon kyphoplasty requires the use of an inflatable bone tamp. Ledlie, balloon kyphoplasty for symptomatic vertebral. Each document posted on the site includes a link to the corresponding official pdf file on govinfo. Spinal fractures osteoporosis causes more than 700,000 spinal fractures each year in the u. Hold an open house for people in the community to come and learn about osteoporosis and treatments. Here are a few ideas to help generate community awareness of osteoporosis, spinal fractures, and minimally invasive treatment options like kyphon balloon kyphoplasty, that your practice offers. The resulting cavity void allows for a controlled deposition of kyphon bone. The complication rate with kyphon balloon kyphoplasty has been demonstrated to be low. This latter study was supplied by the company that owns the system kyphon inc. There are no randomized controlled studies that compared the short and longterm outcomes of kyphoplasty with those of the more conservative standard therapies. Kyphoplasty for the treatment of vertebral compression. Blue cross blue shield medical policy reference manual.
Spinal fractures kyphon balloon kyphoplasty treatment. Kyphon focused on the design, manufacturing, and marketing of the instrumentation used in kyphoplasty procedure s. Percutaneous vertebroplasty kyphoplasty and sacroplasty. Balloon kyphoplasty step by step procedure guide 1. Kyphoplasty for vertebral body compression fracture duration. Subsequent models received fda 510k clearance in 2001 and 2003. February 20 symptoms and treatment of osteoporotic vertebral compression fractures can. 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. It treats pathological fractures of the vertebral body due to osteoporosis. After reduction, the balloons are deflated and removed. Percutaneous vertebroplasty, kyphoplasty, and sacroplasty effective date. In the event of a conflict, the enrollees specific benefit document supersedes this medical policy.
Medinaut kyphoplasty system 510k summary apr 0 4 2914 this summary of 510k safety and effectiveness information is being submitted in accordance with requirements of 21 cfr part 807. Ontario and saskatchewan are the two canadian provinces providing reimbursement for kyphoplasty. Olan, in the comprehensive treatment of the aging spine, 2011. Pdf osteoporotic vertebral compression fractures are a menace to the elderly generation causing diminished quality of life due to pain and deformity find. Kyphopak trays with kyphon xpander ii inflatable bone tamps a02a t15d t15j kx153c kx203c f04b a08e kpx153rbc kyphopak tray, xpander ii 153, ibt kyphon osteo introducer system 21 6 kpx203rbc kyphopak tray, xpander ii 203, ibt kyphon osteo introducer system 21 6 kpx153pbc kyphopak tray, xpander ii 153, ibt. Corporate medical policy vertebroplasty, kyphoplasty, and. Fracture was the result of a fall which occurred 3 days prior to procedure. The rate of cement leakage andor embolization is reported to be 20 to 40% in vertebroplasty and 9% in kyphoplasty.
A minimally invasive treatment for spinal fractures. Bkp kyphon bone cement and cement delivery options medtronic. Utilization of the directional balloon technique to improve the effectiveness of percutaneous kyphoplasty. The kyphon inflatable bone tamp kyphon, santa clara, ca first received fda 510ki clearance in 1998. In the uk the national institute for clinical excellence and health has evaluated the technique and issued the following appraisal and. Of the studies located, 26 satisfied the inclusion criteria. Patient underwent a kyphoplasty t12 thoracic vertebrae 12 out patient procedure for treatment of a t12 vertebral fracture. Of these, 25 have been published in complete form, and one consists of the case registry corresponding to the formulas submitted to the united states food and drug administration fda 510 kd. Balloon kyphoplasty ontario health technology assessment series 2004. Health technology assessment series are freely available in pdf format at the.
249 1374 990 731 646 1478 175 537 289 33 881 1094 330 116 1430 1097 798 792 1504 1172 897 1453 801 885 1355 826 576 698 561 306 1392 717 378 1377 137 1313 941 1245