Zilver Flex’s tight bending radius greatly reduces the likelihood of problematic stent kinking in the SFA. For patients that were found to have died, information on cause of death was not available; therefore, there was also no CEC adjudication or categorization possible for these patients.
However, this analysis does not recognize that 94 of the 237 patients (40%) in the primary PTA arm were actually treated with a Zilver PTX stent yet analyzed as PTA patients and not Zilver PTX patients in this intent-to-treat analysis. Zilver PTX demonstrated high rates of freedom from TLR for Zilver PTX vs PTA/BMS for occluded lesions, severely calcified lesions, lesions > 10 cm in length, and vessels that had a measurement of < 4.5 mm in diameter. No express or implied warranties are made with respect to the Dataset by any Cook Medical company, affiliate, or employee.
Superior torsional flexibility for the twisting forces present in the SFA. In accordance with Cook Medical’s legitimate interest to manage and monitor access to the Dataset to ensure it is used in accordance with our terms and conditions, Cook Medical requires personal information about the requester of the Dataset. If you have questions about our data or Zilver PTX, please contact us at zilverptx@cookmedical.com and a member of our team will respond within 24 hours.
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The main objective of this article is to review the design, safety, and efficacy of the Zilver PTX stent which was engineered to outperform bare metal stents (BMS) in this challenging environment. TEL: +1 949 723 9309
Zilver Flex is painstakingly electropolished to Cook’s industry leading standards, eliminating the imperfections that can lead to stent fracture.
Terms and Conditions | Privacy Policy. Fusce porttitor justo cursus est mattis lobortis. ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent (IMPERIAL) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The FDA’s initial concern was in response to a meta-analysis published in the Journal of the American Heart Association regarding mortality rates related to the use of paclitaxel-coated stents and balloons. The meta-analysis includes Zilver PTX. Zilver PTX Drug-Eluting Peripheral Stent Handle of the Zilver PTX delivery system Used in the …
We also believe that to appropriately analyze the role of paclitaxel on mortality, a deeper understanding of patient-level data is required. Provided below are links to the selected original Zilver PTX data publications. Stent implantation for the treatment of peripheral arterial disease (PAD) in the SFA was initially seen as a salvage option; however, stenting is now routinely offered as initial therapy for patients suffering from claudication and critical limb ischemia.
| Zilver® Vena™ Venous Self-Expanding Stent Zilver Vena Venous Self-Expanding Stent Used in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. The only modifications we’ve made to this data are designed to guarantee that patient privacy and confidentiality are always protected. Zilver 635 Vascular Self-Expanding Stent Used as an adjunct to percutaneous transluminal …
Listing a study does not mean it has been evaluated by the U.S. Federal Government.
The product information on these websites is intended only for licensed physicians and healthcare professionals. 155 North Wacker Drive, Suite 4250, Chicago, IL 60606
This product is already in enquiry request list, Cook® Zilver® PTX® Drug Eluting Peripheral Stent, Cook® Formula™ Renal Balloon Expandable Stent, The Insides Co. and Obex Medical Announce NZ Distribution Agreement, Obex announces Germitec nomination for the 2020 Prix Galien Award for Best Medical Device, Obex Medical achieves Telarc ISO:45001 – the global occupational health and safety management system standard, 10 Recommendations for Point of Care Ultrasound Probe Disinfection, Nylon material resists softening during prolonged catheter use, Catheter is designed for high-flow, high-pressure contrast media injections, Provides the trackability and pushability to reach even the most remote infrapopliteal lesions.
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The RCT included a primary and secondary randomization, as well as an opportunity for patients in the PTA arm to cross over to treatment with Zilver PTX after experiencing a target lesion revascularization (TLR) in the first 12 months. The Zilver PTX stent has established efficacy and safety profiles for paclitaxel in the SFA; however, the development of biocompatible polymers capable of extending the elution time of anti-proliferative agents may lead to more effective stent platforms. USA.gov. Used for dilating puncture sites or catheter tracts.
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Furthermore, clinical benefit was defined as freedom from the following; persistent or worsening claudication, rest pain, ulcers, or tissue loss. |
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The “as-treated” analysis shows a mortality rate of 18.7% for Zilver PTX patients and 17.6% for PTA/BMS patients (p-value = 0.53). According to Cook Medical, the Zilver Vena Venous Self-Expanding Stent is the world’s first-ever stent designed to specifically treat symptomatic iliofemoral venous outflow obstruction. )3��������O�M�M�?�]�����W�_��vR-�a����ﮓ��Q���]�e ik��u����ឿ�`��ɀu﮿�_�0���|w������^���$����_�����j���-k�j���p�V�*���e8�s@iY��W�w���ɀ��V��a���������f��H4����M��@/�+�a��A�o���
Not all products shown on this website may be approved in all regulatory jurisdictions.
Zilver Flex is prospectively designed for the dynamic anatomy of the SFA with an ideal balance of flexibility and strength that ensure maximum durability.
Available in 80cm and 125cm delivery systems.
The device is a self-expanding, small metal, mesh tube coated on …
recently published a peer-reviewed article analyzing Zilver PTX patient-level data from two large studies with long-term follow-up to determine whether there was an increased mortality risk due to paclitaxel.
Stent integrity was assessed by radiography, with site-reported fractures were reviewed by a radiographic core laboratory for classification of fracture type. Keywords:
In the spirit of full transparency, which is a highly valued principle at Cook Medical, we are releasing de-identified patient-level data for our Zilver PTX Randomized Controlled Trial.
Please enable it to take advantage of the complete set of features! This dataset now includes additional vital status data for patients that did not originally complete the study; therefore, the panel pack and panel presentation do not reflect this newer information. Clinical follow-up that occurred through five years was obtained for >90% of eligible patients.
Zilver PTX Global Data Analysis Highlights DES Benefits in Challenging Patient Populations. Superior axial flexibility for the compression that occurs during hip flexion and knee bending.
The Zilver PTX stent was the first self-expanding drug-coated stent approved by the United States Food and Drug Administration (US FDA) for use in the superficial femoral artery (SFA) above the knee. Vivamus felis nisl, semper nec pretium sed, dapibus dictum ex. There was no increased rate of cardiovascular, cancer, or other cause of death for Zilver PTX compared to PTA/BMS. NLM
Five-year results from a Japanese post-market surveillance study aimed at evaluating the Zilver PTX drug-eluting stent (DES) in a real-world population show consistently positive outcomes. The Dataset will only be used for non-commercial research purposes and will not be used for any illegal purpose. Ut maximus interdum diam et ultrices. x����n�F@��?�c�p&�+ɼye+ �
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The product information on these websites is intended only for licensed physicians and healthcare professionals.
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