Medtronic launches kyphon xpander ii ibt system medgadget. Characteristic radiological findings for revision surgery after balloon. There are no randomized controlled studies that compared the short and longterm outcomes of kyphoplasty with those of the more conservative standard therapies. Balloon kyphoplasty is a minimally invasive procedure for the treatment of painful vertebral fractures, which is intended to reduce pain and improve quality of life. In kyphoplasty, the balloon tamp is first inserted through the needle and the balloon is inflated, to create a hole or cavity. The device is mainly used in pkp operation to dilate vertebral body and form a cavity, which is for injecting bone cement to recover and stabilize vertebral body. Kypon balloon kypoplasty i product catalogue 5 bone access kyphon onestep osteo introducer system, trocar and diamond for direct percutaneous 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. For complete information regarding indications for use, contraindications, warnings, precautions. Kyphoplasty for the treatment of vertebral compression.
It is a minimally invasive procedure that aims to relieve pain, restore vertebral height, and. All kyphoplasty was performed using the kyphon balloon kyphoplasty system medtronic spine, llc, sunnyvale, ca, usa. Kyphoplasty of vertebral fractures with kyphos bone. In contrast to kyphons balloon system, a stiff plastic tube. As with vertebroplasty, the effectiveness of kyphoplasty is under debate in the medical community you should discuss. Vertebroplasty is a minimally invasive, nonsurgical therapy used to strengthen a spinal bone vertebra that has been weakened or broken by osteoporosis or. The ip guidance on balloon kyphoplasty for vertebral compression fractures remains current, and should be read in conjunction with the clinical guideline. This elevates the fracture, restoring a more natural shape, while also compacting the soft inner bone to create a cavity in the center of the vertebrae. Balloon kyphoplasty bkp is a minimally invasive procedure that stablises the vertebral fracture and also provides the opportunity to restore vertebral height and reduce spinal kyphosis 14, 21. Indeed, kyphoplasty has been referred to as balloon assisted kyphoplasty. 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. Balloonrelated complications and technical failures in. To assess patient centered outcomes among adults with compression fractures treated by kyphoplasty. Efficacy and safety of balloon kyphoplasty in the treatment.
A variation of vp, kyphoplasty kp, attempts to restore the height and angle of kyphosis of a fractured. Bkp was performed using the kyphon inc system medtronic spine llc, sunnyvale, ca, usa, under general anesthesia. Kyphoplasty patientcentered outcomes via questionnaire daniel carr 1, richard cook 1, doris tong 1,2, matthew bahoura 2, jennifer kanack 1, alicja sobilo 1, stephanie falatko 1, beverly c. It treats pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions. There is now a treatment option called kyphon balloon kyphoplasty that takes as little as 15 minutes to perform, is a minimally invasive outpatient procedure that can reduce or eliminate back pain, and even increase a persons overall mobility and quality of life. Components of kyphoplasty system products kyphoplasty balloon catheter. Oct 10, 2011 the overall procedurerelated complication rate for balloon kyphoplasty in the treatment of vcfs due to cancer n92 is statistically significantly lower than the same rate for vertebroplasty in the treatment of vcfs due to cancer n303 0. The balloon is then removed and the bone cement is injected into the cavity created by the balloon. Balloon kyphoplasty for spinal fractures what to expect. Balloon kyphoplasty ontario health technology assessment series 2004. Like vertebroplasty, kyphoplasty injects special cement into your vertebrae with the additional step of creating space for the treatment with a balloon like device b alloon vertebroplasty.
Kyphon balloon kyphoplasty medicare reimbursement pdf download. Percutaneous balloon kyphoplasty bkp 1 is an interventional radiologic technique that has been used in the treatment of vertebral compression fractures due to various causes such as osteoporosis, metastases, or trauma. Jul 22, 2015 watch a television ad for kyphon balloon kyphoplasty procedure for spinal fractures. Kyphoplasty surgery to treat a fracture from osteoporosis is performed at a hospital under local or general anesthesia. Patients can often go home the same day after kyphoplasty surgery, returning to normal activity levels quickly. Jun 24, 20 in fiscal year 2015, we anticipate our corevalve transcatheter payment. Spinal fracture treatment option balloon kyphoplasty. Hold an open house for people in the community to come and learn about osteoporosis and treatments. Protocol percutaneous balloon kyphoplasty, radiofrequency. Pdf case report describing sacral kyphoplasty in a patient with sacral hemangioma. Vertebral augmentation percutaneous kyphoplasty amazon s3. Bkp was performed using the kyphon inc system medtronic spine llc, sunnyvale, ca, usa, under general anesthesia 12.
Patients with osteoporosis with acute fractures t5l5 were randomized and treated with kyphoplasty n 191 or vertebroplasty n. The kyphoplasty procedure takes about one hour for each vertebra involved. Kyphon balloon kyphoplasty orthopaedic treatment of vertebral compression fractures a free powerpoint ppt presentation displayed as a flash slide show on id. Pdf kyphoplasty patientcentered outcomes via questionnaire. Kyphopak trays 22 kyphopak trays kyphon express first fracture osteo introducer with cement delivery system kpe1003cds kyphon xpander inflation syringes a08a kyphon cds cement cartridges cc02a kyphon cement delivery gun and bone filler device size 2 cds2a kyphon express osteo introducer system diamond and bevel t34a. One hundred fiftyone patients completed the telephone satisfaction survey. 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. Kyphoplasty kp and vertebroplasty vp have been successfully employed for many years for the treatment of osteoporotic vertebral fractures. T15j kyphon advanced osteo introducer system t15e advanced diamond drill trocar. In this procedure, a doctor inserts and inflates a balloon to create an opening for the mixture. 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.
Medinaut kyphoplasty system 510k summary apr 0 4 2914. Ppt kyphon powerpoint presentation free to download. This trial compares the efficacy and safety of balloon kyphoplasty and vertebroplasty. A randomized trial comparing balloon kyphoplasty and.
Unlike vertebroplasty, kyphoplasty aims not only to secure fracture fixation and stabilization, but also to reconstruct the vertebral anatomy and correct the kyphotic spinal deformity. Description balloon kyphoplasty is performed by inserting a balloon like device inflatable bone tamp through a channel created by a hand drill in the fractured vertebrae. Important safety information is shown at the end of the video. Kyphosis of the spine may compromise the biomechanics of the spine, which in turn predisposes to increased risk of further fractures in the adjacent.
This metaanalysis was aimed to explore the overall safety and efficacy of balloon kyphoplasty versus percutaneous vertebroplasty for osteoporotic vertebral compression. Balloon kyphoplasty is a minimally invasive treatment for spinal compression fractures also called vertebral compression fractures of vcfs. Controversial issues in kyphoplasty and vertebroplasty in. Vertebral fractures to be treated with this interventional procedure are as. During kyphoplasty kyphon kyph, the balloon and cement are introduced through the pedicle of the vertebrtal body. Balloon kyphoplasty should be restricted to facilities that have sufficient volumes to develop and maintain the expertise required to maximize good quality outcomes. Complications and safety aspects of kyphoplasty for.
In particular we compare nonsurgical management nsm and kp and vp, in terms of clinical. Pdf sacral kyphoplasty for relieving pain caused by sacral. The complication rate with kyphon balloon kyphoplasty has been demonstrated to be low. Allows for directional control of inflatable bone tamps during a balloon kyphoplasty procedure additional height restoration in a.
Aim of this paper is to give an overview of the state of the art about vertebroplasty and kyphoplasty, discussing the indications. Kyphon balloon kyphoplasty has been shown to reduce or eliminate back pain from a spinal fracture, as well as restore vertebral body height. Bkp kyphon vertebral compression fracture prep kit medtronic. 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.
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. It is sometimes compared to another vertebral augmentation procedure called vertebroplasty, which may also be performed using minimally invasive techniques. Balloon kyphoplasty is an effective, minimally invasive procedure for the stabilization of osteoporotic vertebral fractures, leading to a statistically significant reduction of pain status. Xrays andor a ct scan may be performed at the end of the procedure to check the distribution of the cement. Download the balloon kyphoplasty pdf document here 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.
Download technical manuals for kyphon products from the medtronic manual library. Kyphoplasty system an overview sciencedirect topics. Balloon kyphoplasty is a minimally invasive procedure designed to repair vertebral compression fractures vcfs by reducing and stabilizing the fractures. Overview balloon kyphoplasty for vertebral compression.
Percutaneous balloon kyphoplasty, radiofrequency kyphoplasty rfk, and mechanical vertebral augmentation. Balloon kyphoplasty for vertebral compression fractures nice. The staxx fx structural kyphoplasty system is a novel device to be used in kyphoplasty procedures. Patients were positioned in prone, on a fourposter frame. Kyphoplasty and vertebroplasty for the treatment of painful osteoporotic vertebral compression fractures. A 3question survey was administered via telephone to patients who had a kyphoplasty procedure performed from 20082011. Kyphoplasty and vertebroplasty 6 comparing the kivar system to balloon kyphoplasty in treatment of osteoporotic vertebral compression fractures.
Kyphon balloon kyphoplasty tennessee health and wellness. This device is implanted in the fractured vertebra via a percutaneous, peripedicular surgical approach. Unlike traditional balloon kyphoplasty, structural kyphoplasty allows for physiciancontrolled fracture reduction. Balloon kyphoplasty in the treatment of metastatic disease. Incidence of fracture in adjacent levels in patients.
Balloon kyphoplasty for spinal fractures medtronic. Learn about the kyphon balloon kyphoplasty procedure and products. Pdf kyphoplasty in osteoporotic vertebral compression fractures. Stepbystep balloons are inflated the balloons are inflated with a liquid visible under xray guidance inside the collapsed vertebra. The resulting cavity void allows for a controlled deposition of kyphon bone cement which helps form an internal cast. After deflating and removing the balloon, a cementlike material is inserted into the. Learn how medtronic balloon kyphoplasty has transformed. Through a pair of small incisions, each approximately 1 cm in length, the specialty physician uses a needle and cannula to create a small pathway into each side of a fractured vertebral body. Kyphoplasty patientcentered outcomes via questionnaire. Balloon kyphoplasty is a minimally invasive surgical procedure performed to treat one or more vertebral compression fractures vcfs. Apr 10, 2016 aarp health insurance plans pdf download medicare replacement pdf download medicare benefits pdf download medicare part b pdf download kyphon balloon kyphoplasty medicare reimbursement. 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. 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.
Neither vertebroplasty nor percutaneous vertebral augmentation is indicated for. Bone cements for percutaneous vertebroplasty and balloon. Television ad for kyphon balloon kyphoplasty youtube. Olan, in the comprehensive treatment of the aging spine, 2011. The material hardens quickly, stabilizing the bone.
Survey the included patients were contacted through telephone numbers obtained in the demographic data of their electronic health record. During the kyphoplasty procedure, the cement is introduced in a low pressure manner, since the cement is filling the void in the bone which was created by the balloon. Kyphoplasty can restore a damaged vertebras height and may also relieve pain. Several trials have compared vertebral augmentation with nonsurgical treatment for vertebral compression fractures. Other logistics for a typical kyphoplasty procedure are. Aarp health insurance plans pdf download medicare replacement pdf download medicare benefits pdf download medicare part b pdf download kyphon balloon kyphoplasty medicare reimbursement. The kyphon assist directional cannula is compatible across the medtronic portfolio of balloon kyphoplasty products, including the kyphon xpander ii inflatable bone tamps. A randomized trial comparing 2 techniques of balloon. Kyphon balloon kyphoplasty has been shown to be beneficial for patients in whom restoration of vertebral height is feasible. Treatment of pathologic spinal fractures with combined radiofrequency ablation and balloon kyphoplasty article pdf available in world journal of surgical oncology 71. 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.
Bkp involves the use of a balloon to create a cavity within the cancellous bone, followed with bone. New directional cannula provides more flexibility and. The aim of this study is to evaluate the efficacy and safety of balloon kyphoplasty bk in the management of vertebral compression fractures vcfs. The kyphon balloon kyphoplasty platform is used to treat pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions. After reduction, the balloons are deflated and removed. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Besides conventional vertebral cement augmentation techniques balloon kyphoplasty has become a popular tool to address painful thoracic and lumbar. One study of 360 procedures in 222 patients reported 38 cement leaks 11% of procedures, with one resulting in an episode of radiculopathy the patient recovered with selective nerve block and rehabilitation. Characteristic radiological findings for revision surgery. Dec 01, 2004 balloon kyphoplasty is a reasonable alternative to vertebroplasty, although it must be reiterated that this conclusion is based on evidence from level 4 studies. Percutaneous balloon kyphoplasty in the treatment of pathological vertebral body fracture and deformity in multiple myeloma. After deflating and removing the balloon, a cementlike material is inserted into the cavity through a lowpressure injection. Benign lesions include hemangioma and giant cell tumor.
A small balloon is guided through each cannula into the vertebra. Stepbystep placement of balloons balloon catheters are inserted into the incisions and into the body of the affected vertebra. Balloon kyphoplasty in the management of vertebral compression fractures. A special balloon is then inserted through the tube and inflated.
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