Generating an epub file may take a long time, please be patient. But, if the kyphoplasty procedure involves an open approach, requiring a surgical incision, the resulting. In addition to providing rapid pain relief, balloon tamp kyphoplasty has the advantage to reduce acute. The proper atraumatic technique enables minimal retraction or disturbance of the nerve roots and dura, and maintains the stability of the facet joints. Current instrumentation systems limit the ability to. The purpose of this document is to provide written information regarding the risks, benefits, and alternative treatment modalities for kyphoplasty. The incidence of leakage during kyphoplasty is reported ranging from 0 to. The authors introduce its surgical technique and early clinical results. Percutaneous vertebroplasty and balloon kyphoplasty kce. Kyphoplasty involves the penetration of the vertebral body with a trochar followed by insertion of an inflatable balloon tamp ibt. Objectives the authors have performed a singleballoon kyphoplasty using farlateral extrapedicular approach in the treatment of osteoporotic vertebral compression fractures. A preoperative prophylactic singleshot intravenous dose of a firstgeneration cephalosporin was administered to each patient, and fluoroscopy was. Balloon kyphoplasty or mechanical vertebral augmentation using kiva are considered investigational for all other indications, including use in acute vertebral fractures due to osteoporosis or trauma. Medinaut kyphoplasty system kyphx inflatable bone tamp 51 0k na k010246.
The rate of success in restoration of vertebral body height after kyphoplasty ranges between 0 and 90%. The resulting cavity void allows for a controlled deposition of kyphon bone cement which helps form an internal cast. Refer to the package insert for a complete list of indications and limitations. Absorbable stitches are used under the skin to close the incision. As both open and closing wedge procedures are associated with complications leading to disabling morbidity surgeon are often hesitant to. The kyphoplasty set is also necessary to perform the operation figure 1a,1b,1c. Indications, surgical technique and evaluation on a series of 64 patients treated with percutaneous posterior osteosynthesis combined with kyphoplasty or anterior arthrodesis. Multidimensional surgical imaging system medtronic navigation. Surgical technique product information bibliography synflate 2 ao spine principles 4 indications and contraindications 5 preoperative planning 6 patient positioning 8 approach 9 access 12 biopsy 16 creation of access channel and 18. Version 1 december 20, 2007 kyphoplasty informed consent information introduction. Learn about the kyphon balloon kyphoplasty procedure and products. Medtronic launches new balloon kyphoplasty products for treating. Balloon kyphoplasty experienced important benefits, compared to nonsurgical treatments811.
Percutaneous balloon kyphoplasty for the treatment of. The patient is placed prone in an appropriate manner to avoid specific pressure points. The minimally invasive technique has high success rates for stopping pain caused by fractures, stabilizing the bone, and restoring some or. Percutaneous vertebroplasty and balloon kyphoplasty. Medinaut kyphoplasty system 510k summary apr 0 4 2914. By utilizing a direct lateral approach to the spine, this procedure enables placement of a large interbody graft into the disc space for anterior column support while avoiding the. Medtronic data on file kyphon cement delivery system. Figure 1, the procedure was performed as described in the technique guide.
The following corporate literature is appended in pdf files below. Kp is a similar technique, but it differs from vp in that a balloon is inserted into the vertebral body and is insufflated to reduce the fracturerestoring vertebral height. Patients 300 were randomly assigned by computergenerated sequence to either balloon kyphoplasty n149 or nonsurgical care n151. Surgical management of lumbar and thoracolumbar spinal fractures. In that case, medtronic claimed kyphons patents were invalid. Kyphoplasty is a procedure used to treat vertebral compression fractures and abnormal configurations typically caused by osteoporosis. Your doctor may use imaging guidance to inject a cement mixture into the fractured bone vertebroplasty or insert a balloon into the fractured bone. Kyphon balloon kyphoplasty information for your family.
Learn how medtronic balloon kyphoplasty has transformed. Download technical manuals for kyphon products from the medtronic manual library. All kyphoplasties were performing using kyphon balloon kyphoplasty medtronic, memphis, tn. 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. Stepbystep you have been diagnosed with a vertebral compression fracture. Any surgical technique in which a large incision is not required. Patients were sent home the same day if no complications occurred. Balloon kyphoplasty is a minimally invasive procedure designed to repair vertebral compression fractures vcfs by reducing and stabilizing the fractures. We believe that there is a need to better address the surgical challenges we face in the posterior cervical and upper thoracic spine. In the uk the national institute for clinical excellence and health has evaluated the technique and issued the following appraisal and. Cementaugmented pedicle screw instrumentation and balloonguided kyphoplasty for a lumbar burst fracture in a 97yearold patient.
The systems ability to memorize imaging positions m2d eliminates manual repositioning. Medtronic receives fda approval for its second cement solution to treat sacral fractures. Surgical management of lumbar and thoracolumbar spinal. Medtronic spine sales decline waiting for infuse and. Kyphoplasty procedure versus nonsurgical treatment 4,5, such as. Balloon kyphoplasty is a minimally invasive procedure designed to repair vertebral compression fractures. During a call with wall street analysts on may 20, 2014, company leaders said with core spine sales growing, they are counting on the stabilization of kyphoplasty and infuse to. We provide you with the broadest portfolio of products for vcf treatments. The direct lateral interbody fusion procedure provides spine surgeons with a complete minimally invasive solution for the treatment of degenerative lumbar conditions. Is the site resulting from a kyphoplasty procedure considered a surgical wound when answering m40. The surgeons real dose exposure during balloon kyphoplasty. A special skin glue is then used on the surface of the skin. The ideal surgical technique and implant design minimize damage to anatomical structures, i.
Carefusion has a unique strategy for taking on medtronickyphon, the 800pound gorilla of kyphoplasty. Health technology assessment of scheduled procedures. Spinal surgical services must be available for emergency decompressive surgery secondary to epidural. The sites listed above are not managed or monitored by medtronic and are listed as a courtesy. Balloon kyphoplasty for spinal fractures medtronic. E51930 september 20 with 188 reads how we measure reads. Items in these kits usually include surgical instruments and devices such as vertebral balloons also known. The medtronic model reported that kyphoplasty was costeffective when. Surgical equipment several items of equipment are needed to perform the kyphoplasty first, a draped carm fluoroscopy and monitor are essential for verification of the position and localization of the patient during surgery. Inflation of the balloon tamp restores the vertebral body back towards its original height, while creating a cavity to be filled with bone void filler. Vertebral augmentation percutaneous kyphoplasty amazon s3.
The surgical system is marketed by kyphon which has recently become part of medtronic inc. Postoperatively, patients were not braced and had no physical restrictions. It treats pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions. After reduction, the balloons are deflated and removed. Radiofrequency kyphoplasty is considered investigational. Vp is an imagingguided minimally invasive technique in which cement is injected into the fractured vertebral body fig. Are too elderly or frail to tolerate open spinal surgery, or who have bones too weak for surgical spinal repair that have vertebral damage due to a malignant tumor. Between may 16, 2005, and march 11, 2008, 4 patients were enrolled and randomly assigned to kyphoplasty n70 or nonsurgical management n64. Prepackaged collections either custom or standard of devices, instruments, and supplies necessary to perform minimumaccess spinal surgery procedures such as the injection of bone cement into a fractured vertebra i.
Principal investigator zonmw funds with cofinancing from medtronic inc. The following presentation will walk you through this minimally invasive procedure step by step. Kyphoplasty can be performed in patients who have severe pain requiring hospitalization or conditions that limit bed rest and medications. To our knowledge, this surgical procedure has not yet been reported in a patient of such a high age and accompanying neurological. In our center, all balloon kyphoplasty procedures bkp are now performed. Methods clinical outcomes were determined by comparison of preoperative and postoperative visual analog scale score. Kyphoplasty introduced a method of creating bilateral bone voids and in many cases.
After completion of the kyphoplasty, the wound is irrigated with antibiotic solution to decrease the risk of infection. Vertebral augmentation kyphoplasty surgical technique vertebral augmentation many times called kyphoplasty with cement or other bone strengthening devices titanium cages, etc is typically performed for osteoporotic compression fractures, painful tumors of the spine, or. Kyphon balloon kyphoplasty bkp is a minimally invasive surgical procedure indicated for treatment of. The report profiles some of the leading players in the global kyphoplasty market. Balloon kyphoplasty step by step procedure guide 1. A transforaminal lumbar interbody fusion tlif is performed to remove a portion of a disc that is the source of back or leg pain. From our ivas inflatable vertebral augmentation system to our mixer and delivery systems, implants and needles, our portfolio of products helps you customize your treatment approach for your patients.
Surgical technique percutaneous kyphoplasty was performed under local anesthesia with the patient positioned prone on a radiolucent table with hisher spine extended by chest and pelvic bolsters. Mechanical vertebral augmentation using any other device is considered investigational. First, wait for kyphons original kyphoplasty patents to expire, launch your own product and then go to court and accuse medtronic of cheating to gain a nearmonopoly in the marketplace. Percutaneous reference frame has been attached on psis posterior superior iliac spine for patient referencing. Criteria for the appropriate treatment of osteoporotic vertebral compression fractures article pdf available in pain physician 165. The kyphon expresstm ii balloon kyphoplasty platform features a maximum pressure rating of. Clinical and radiographic results of kyphoplasty with mid. Investigators referred all participants in both groups for treatment with calcium and vitamin d supplements and antiresorptive or anabolic agents. Medtronic the medinaut kyphloplasty kyphx inflatable bone tamps arc system is intended to be used intended to be used as conventional. This case report describes the safe technique in 97year old patient with a lumbar burst fracture and neurological deficits, treated by cementaugmented pedicle screw instrumentation and balloonguided kyphoplasty. Developed in 1998 by an orthopedic surgeon in the united states and then.