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. The adverse events were combined because all patients were treated with Zilver PTX stents. Conclusion: The Zilver Vena stent appeared to be safe, easy to deploy, and showed good clinical outcome. Not all products are approved in all regulatory jurisdictions. Regulatory approval for Cook Medical system. Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts “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. 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.
The FEA that will be performed on this curved artery will allow the simultaneous study of stent flexibility and strength. the PI's rights to discuss or publish trial results after the trial is completed. • 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. The new system provides simple deployment for the world’s-first and only-approved drug-eluting stent for the superficial femoral artery (SFA). COVID-19 is an emerging, rapidly evolving situation. The technical success with deployment of the stents in the intended position was 75%. Not all products shown on this website may be approved in all regulatory jurisdictions. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Zilver Flex 35 Vascular Self-Expanding Stent. 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.
His clinical expertise includes cholangiocarcinoma and biliary tract disorders.
During this procedure, he’s using two 12cm Zilver 635 Biliary Self-Expanding Stents over Acrobat 2 Calibrated Tip Wire Guides. Optimization of the stent design has the advantage to improve the stent behavior during deployment. *ZILBS-635 verification testing on file for deployment accuracy. 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. Dr. Ginsberg is the Director of Endoscopic Services, Professor of Surgery and Professor of Medicine at the Hospital of the University of Pennsylvania.
“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.
To test the hypothesis whether the percent change in stent length is contained within [-10%, 10%]. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). 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. 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. “We have not only succeeded in our engineering and production goals, but have surpassed many of our expectations for several of the new features.”. All-Cause Mortality Stented Patients Affected / at Risk (%) You will be leaving the Cook Medical website that you were viewing and going to a Cook Medical website for another region or country. The equivalence margin is +/- 10%, type I error is assumed to be 0.05, with a power of 0.8. - Average Lesion Length. 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.
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. ), exacerbation of COPD (Due to a pre-existing condition. Good clinical effect with resolution of superior vena cava syndrome was achieved in 11 of the 12 patients (92%). 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. Respiratory, thoracic and mediastinal disorders, Frequency Threshold for Reporting Other Adverse Events, Scott Snyder, PhD, Director of Clinical Science and Biostatistics.
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