The addition of contrast medium increases,medicine,medical supply,medical supplies,medical product. Medtronic enables pacemaker monitoring by smartphone. The resulting cavity void allows for a controlled deposition of kyphon bone cement which helps form an internal cast. Kyphon xpander osteo introducer system by medtronic allows user to manually inflate or deflate balloon by injecting and aspirating fluid or air during procedures singleuse to reduce crosscontamination. The devices are fda approved or approved by corresponding national agencies for this indication. Medtronic kyphon kyphx express directional bone filler device, size 2. We are a liquidator of sutures and other surgical items from ethicon, covidien autosuture, synthes, stryker, arthrex and are able to pass our savings on to you. 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. New medtronic kpt1502 kyphon kyphopak first fracture tray. Event description it was reported that a patient underwent a balloon kyphoplasty procedure bkp at l3 and intraoperatively, the left balloon would not inflate and upon inspection outside the vertebral body, the balloon began leaking contrast agent through multiple holes. It has a lot of cool features to help with your diabetic life.
The rotating handle allows the surgeon to deliver a measured volume of the fluid that inflates the balloon. See the different types and sizes of kyphon balloon and inflation devices for balloon kyphoplasty. Like an angioplasty balloon, it can be viewed under xray image guidance because it is inflated with radiopaque contrast medium. Our kyphx xpander inflation syringe is a disposable sterile device with a rotating handle and a builtin pressure gauge that precisely controls the inflation of our kyphx inflatable bone tamps. Kyphon xpander inflatable bone tamps, 153 k09a kyphon 11g bone acccess needle kyphon osteo introducer system t15d kyphon bone filler devices f04b kyphon xpander inflation syringes a08a kyphon xpander first fracture with osteo introducer system kpt1502. 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 device functionality and programming described on medtronic academy are based on medtronic products and. For pkp, inflatable bone tamps ref k02a, kyphx xpander inflatable bone tamp kyphon, medtronic, minnesota were then placed into the vertebral bodies unilaterally. Medical device kyphon xpander bone tamp inflatable. Kyphx xpander inflatable bone tamp, size 153, catalog number k09a, manufactured by kyphon sarl, swi.
A dedicated delivery system ref f04b, kyphx bone filler device, kyphon inc. These balloons and inflation devices are available to assist in fracture reduction. Medtronic has received fda 510k clearance for the kyphon xpander ii inflatable bone tamp for treating vertebral compression fractures with the minimally invasive kyphon balloon kyphoplasty, according to a company news release. Medtronic provides information on ballon kyphoplasty and how this minimally invasive procedure can repair spinal fractures, many caused by osteoporosis. Medtronic launches kyphon xpander ii ibt system medgadget. There are two options available for use with xpander 8ga a23 and. Fda 510k applications for medical device product code hrx arthroscope. The complication rate with kyphon balloon kyphoplasty has been demonstrated to be low. While i understand that the medtronic app is written for the iphone, the question for the electronic engineers at medtronic is whether the iphone will transmit the bg level and graph shown in the article to the face of the iwatch. Kyphx xpander inflatable bone tamp, size 153, catalog number k09a, manufactured by kyphon sarl, switzerland. Stryker hit with patent suit over spinal treatment devices. Kyphx xpander inflatable bone tamp,the kyphx xpander inflatable bone tamp is an orthopedic balloon designed to inflate in cancellous bone while resisting puncture. Discover the advantages of the new resolute onyx 4. Medtronic receives fda 510k clearance for kyphon xpander ii.
Minimed connect app user guides medtronic diabetes. Kyphx xpander inflatable bone tamp for the reduction of vertebral. This adapter is used to fill multiple bone filler devices at once. Medtronic, kpt1505, medtronic kyphon xpander 153 ibt, one. Recently, medtronic launched two products to add to bkp, which is used for treating vcfs. Spinal fractures kyphon balloon kyphoplasty treatment medtronic. Bkp kyphon balloons and inflation devices medtronic. Medtronic is the worlds largest medical technology company, offering an unprecedented breadth and depth of innovative therapies to fulfill the mission of alleviating pain, restoring health, and extending life. Changes in a patients disease andor medications may alter the efficacy of a devices programmed parameters or related features and results may vary. Introducing convenient mobile access to your pump and cgm data with minimed connect. See kyphon balloon kyphoplasty accessories including currettes, needles, and biopsy devices. After reduction, the balloons are deflated and removed.
Minimed 630g system support comparing infusion sets comparing infusion sets device. Kyphon kyphx xpander inflatable bone tamp, first fracture 15mm, size 3. There are two options available for use with xpander 8ga a23 and express 10ga a22 access tools. Prospective comparative study to compare safety and. Kyphon xpander osteo introducer system by medtronic. Medtronic, kpt2005, medtronic kyphon xpander 203 ibt, one. One month post procedure, the patient presented to another physician with unknown symptoms.
Event description it was reported that a physician performed a kyphoplasty procedure on a patient. New medtronic kpt2004 kyphon xpander balloon kyphoplasty. Medtronic, a08a, medtronic kyphon xpander inflation. Showcasing the latest enhancement of our original and proven premium kyphoplasty technology. Medtronic has launched the new kyphon xpander ii ibt system, which includes the kyphon xpander ii inflatable bone tamp ibt and the kyphon inflation. Kyphon balloon kyphoplasty uses orthopaedic balloons to restore vertebral height and correct angular deformity from vertebral compression fractures vcf. Introducing convenient mobile access to your pump and cgm. Catheterballoon inflator, singleuse a device designed to manually inflate and regulate the pressure of a balloon catheter e.
The resulting cavity void allows for a controlled deposition of kyphon bone cement. Order as a bundle with kyphon xpede cement and mixer for use with xpander 8ga cx01bmt3 or with express 10ga cx01bmt2. Medical device recalls food and drug administration. A prospective, international, randomized, noninferiority. Catalog number k09a, lot number 50000231, upn 00858196001161. What kind of data does the uploader send to the minimed connect app. The new mycarelink smart monitor from medtronic, just approved by the fda, enables patients with implantable pacemakers to use their smartphones to transmit secure data from their pacemakers to their physicians the mycarelink app is available for free on android and apple platforms and works in tandem with a physicianprescribed portable device reader. Current sensor glucose reading with high and low limits shown on a graph 3, 6, 12, 24hour views, time until your next blood glucose bg calibration, and number of days before next sensor change. Fda 510k applications for medical device product code.
Searchable database of fda 510k applications and descisions. Medtronic s medical therapies treat cardiac and vascular diseases, diabetes, and neurological and musculoskeletal conditions. Kyphon inflatable bone tamps ibt, or orthopaedic balloons, are available for use with 8 and 10ga introducers in three lengths 10mm, 15mm, and 20mm to address differing vertebral anatomy. Sy 1203 making an impact on peripheral vascular restenosis. Medtronic kyphon xpander ii inflatable bone temp bone filler device each expired 1 in stock. Medtronic kyphon xpander 103 ibt, onestep osteo introducer, tray only. Class 2 device recall kyphx xpander inflatable bone tamp.
Kyphon xpander and kyphon express inflatable bone tamps ibt are intended to be used as conventional bone tamps for the reduction of fractures andor. Bkp kyphon bone cement and cement delivery options medtronic. Medtronic spine llc, formerly kyphon inc 1221 crossman ave sunnyvale ca 940891103. Use these educational materials to help patients and the general public understand the balloon kyphoplasty procedure and its benefits.