The product information on these websites is intended only for licensed physicians and healthcare professionals. Conclusion: The Zilver Vena stent appeared to be safe, easy to deploy, and showed good clinical outcome. You will be leaving the Cook Medical website that you were viewing and going to a Cook Medical website for another region or country. 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.
Dr. Gregory Ginsberg was not a paid consultant for Cook Medical at the time this video was made. Warning: The safety and effectiveness of this device for use in the vascular system have not been established. Get Email about News, Products, and Events from Cook Medical. All-Cause Mortality Stented Patients Affected / at Risk (%) The equivalence margin is +/- 10%, type I error is assumed to be 0.05, with a power of 0.8.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
The adverse events were combined because all patients were treated with Zilver PTX stents. His clinical expertise includes cholangiocarcinoma and biliary tract disorders. 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. Sign Up. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Not all products are approved in all regulatory jurisdictions.
The thumbwheel design features include an ergonomic handle that facilitates single-handed deployment.
Optimization of the stent design has the advantage to improve the stent behavior during deployment. Stent designed for SFA* Multi-directional flexibility to conform to the natural vessel movement. 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. Principal Investigators are NOT employed by the organization sponsoring the study. CE Mark approval has been awarded to the new rotating thumbwheel deployment system for Cook Medical’s Zilver PTX drug-eluting peripheral stent. ), lumbar protrusion (Due to other medical problems.). Regulatory approval for Cook Medical system. ), exacerbation of COPD (Due to a pre-existing condition. to 3.5, Indicates events were collected by systematic assessment, failed hemodialysis shunt requiring revision (Due to a pre-existing condition. “We have not only succeeded in our engineering and production goals, but have surpassed many of our expectations for several of the new features.”. • 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. 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.
Not all products shown on this website may be approved in all regulatory jurisdictions. 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. 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 technical success with deployment of the stents in the intended position was 75%.
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