You will be leaving the Cook Medical website that you were viewing and going to a Cook Medical website for another region or country. Consult with your local Cook representative, distribution company or customer support center for details. “We have not only succeeded in our engineering and production goals, but have surpassed many of our expectations for several of the new features.”. ), exacerbation of COPD (Due to a pre-existing condition. Respiratory, thoracic and mediastinal disorders, Frequency Threshold for Reporting Other Adverse Events, Scott Snyder, PhD, Director of Clinical Science and Biostatistics. The safety of Zilver PTX has been previously established and the primary objective of this study was changes in post-deployment stent length; i.e. The thumbwheel design features include an ergonomic handle that facilitates single-handed deployment. Regulatory approval for Cook Medical system. The safety of Zilver PTX has been previously established and the primary objective of this study was changes in post-deployment stent length; i.e. Stent designed for SFA* Multi-directional flexibility to conform to the natural vessel movement. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). The technical success with deployment of the stents in the intended position was 75%. • Based on Zilver Flex® stent platform that features fracture-resistance technology3 (1.9% fracture rate through 5 years) along with balanced flexibility and radial force • Reduced package size4 • Up to 120 mm stent lengths. Zilver Flex 35 Vascular Self-Expanding Stent. There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts CE Mark approval has been awarded to the new rotating thumbwheel deployment system for Cook Medical’s Zilver PTX drug-eluting peripheral stent. All-Cause Mortality Stented Patients Affected / at Risk (%) During this procedure, he’s using two 12cm Zilver 635 Biliary Self-Expanding Stents over Acrobat 2 Calibrated Tip Wire Guides. Warning: The safety and effectiveness of this device for use in the vascular system have not been established. In addition to the new deployment system, 120mm-length Zilver PTX stents are also now available, while all lengths on the new delivery system are now CE marked with a 24-month shelf life. ), lumbar protrusion (Due to other medical problems.). The FEA that will be performed on this curved artery will allow the simultaneous study of stent flexibility and strength. “Our objective when designing the new handle was to improve accuracy and deliverability on the previous pin-and-pull system,” said Lindsay Koren, Cook Medical's global product manager for stent development. Cook Medical has improved the Zilver 635® Biliary Self-Expanding Stent, with a redesigned 6Fr introducer and two new longer-length stents, to allow precise* endoscopic stent placement from the hilum through the papilla. Study record managers: refer to the Data Element Definitions if submitting registration or results information. *ZILBS-635 verification testing on file for deployment accuracy. The product information on these websites is intended only for licensed physicians and healthcare professionals. immediately post-procedure. In addition to the new deployment system, 120mm-length Zilver PTX stents are also now available, while all lengths on the new delivery system are now CE marked with a 24-month shelf life. Dr Andrew Holden, director of interventional services at Auckland City Hospital and an associate professor of radiology at Auckland University School of Medicine in New Zealand, is the first physician in the world to use the new deployment system in his practice. Good clinical effect with resolution of superior vena cava syndrome was achieved in 11 of the 12 patients (92%). the PI's rights to discuss or publish trial results after the trial is completed. Thus, a small p-value indicates a 95% confidence interval covers 0. “The new thumbwheel system allows for greater control and accuracy making it significantly easier for me to deploy the Zilver PTX stent.”, Cook Medical reveals four-year Zilver PTX FTLR trial data, UK surgeons 'slow' to adopt new device that could prevent amputations, World first for Cook Medical's new drug-eluting balloon, Life-saving angioplasty technique turns 50, Biotronik includes Class 7 cleanroom at new Singapore facility, NICE consults on plans to support new device which avoids surgery for enlarged prostate glands, Case study: ‘Reflux ruined my teenage years’, Ground-breaking new cardiac implant fitted for first time by UK medics, Regulator's 'no sale' plea to vaginal implant manufacturers, Revolutionary device proves a lifeline for stroke patients, Cardiologists use new drug-coated angioplasty balloon as first-choice restenosis treatment. Zilver PTX Zilver Flex Arm* (Cook Medical)14 n/a 73.0% Durability Protege EverFlex (Medtronic)15 79.1% 72.2% ** FTLR - Freedom from Target Lesion Revascularization; † PP - Primary Patency; ††A.L.L. Read our, ClinicalTrials.gov Identifier: NCT01348425, Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment, Percent Change in Stent Length Upon Deployment, During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment). Cook Medical has improved the Zilver 635® Biliary Self-Expanding Stent, with a redesigned 6Fr introducer and two new longer-length stents, to allow precise* endoscopic stent placement from the hilum through the papilla. The adverse events were combined because all patients were treated with Zilver PTX stents. Zilver PTX stent is low, ranging from 0.4 mg for the 40 mm length stent to 1.3 mg for the 140 mm length stent. Please remove one or more studies before adding more. Optimization of the stent design has the advantage to improve the stent behavior during deployment. immediately post-procedure. Here, Gregory Ginsberg, MD, performs a simultaneous double stenting procedure to palliate a patient with multifocal stricturing in the common bile duct and hilar strictures in both left and right sides, resulting from a cholangiocarcinoma. Not all products shown on this website may be approved in all regulatory jurisdictions. The adverse events were combined because all patients were treated with Zilver PTX stents. “Based on my own experience, I’ve found that Cook’s new Zilver PTX deployment system has overcome the challenges associated with the previous system,” he said. - Average Lesion Length. Principal Investigators are NOT employed by the organization sponsoring the study. Why Should I Register and Submit Results? The new system provides simple deployment for the world’s-first and only-approved drug-eluting stent for the superficial femoral artery (SFA). Schuirman's TOST equivalence test on change in stent length upon deployment between longer and shorter stents. His clinical expertise includes cholangiocarcinoma and biliary tract disorders. Not all products are approved in all regulatory jurisdictions. The equivalence margin is +/- 10%, type I error is assumed to be 0.05, with a power of 0.8. Get Email about News, Products, and Events from Cook Medical. The alternative hypothesis is equivalence in mean change in stent length upon deployment between longer and shorter stents, i.e., the difference in mean change between the longer and shorter stents is close to 0. To test the hypothesis whether the percent change in stent length is contained within [-10%, 10%]. COVID-19 is an emerging, rapidly evolving situation. Sign Up. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Used in the iliac, superficial femoral artery (SFA) and above-the-knee popliteal artery for the following treatments: • Arteriosclerotic stenosis • Total occlusions that have been recanalisated The product provides mechanical support to maintain constant blood flow of the vessel. Conclusion: The Zilver Vena stent appeared to be safe, easy to deploy, and showed good clinical outcome. Dr. Gregory Ginsberg was not a paid consultant for Cook Medical at the time this video was made. Dr. Ginsberg is the Director of Endoscopic Services, Professor of Surgery and Professor of Medicine at the Hospital of the University of Pennsylvania. Information provided by (Responsible Party): Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent, Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only, Unit of Measure: Change in stent length (%), -2.0 to 3.5, Indicates events were collected by systematic assessment, failed hemodialysis shunt requiring revision (Due to a pre-existing condition. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. In a future work, the stent deployment will be fully modeled inside a curved artery that is made of 3 layers and containing a cholesterol plaque.
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