�`�h$�`� ҧ��8r`4U�a function rct(){ Speaking to the CIRSE audience, Kichikawa said these figures were indicative of: “Consistently good results in challenging patient population including those with diabetes, renal failure, long lesions, in-stent restenosis, no runoff or critical limb ischaemia.” The ankle-brachial index and Rutherford scores further indicated that clinical improvement was maintained over-time, after the rapid increase in Rutherford scores one year into the trial. COVID-19 is an emerging, rapidly evolving situation. Sign Up. View Cook Medical’s updated letter to physicians on paclitaxel. Delivers flexibility and kink resistance which enhance your ability to travel through the tortuous vasculature of the lower leg. Not all products are approved in all regulatory jurisdictions. NIH In addition, evidence highlighting the benefits and risks associated with paclitaxel-coated devices should be communicated to physicians and patients so that an informed choice can be made. Used as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic vascular disease of the iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Causes of death were examined between the “as-treated” Zilver PTX and PTA/BMS groups. The addition of the new data confirmed no mortality signal for Zilver PTX. 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. Email: info@bibamedical.com Superior axial flexibility for the compression that occurs during hip flexion and knee bending. ә\�ID}��3��r���>F��� Zilver Flex’s tight bending radius greatly reduces the likelihood of problematic stent kinking in the SFA. We also believe that to appropriately analyze the role of paclitaxel on mortality, a deeper understanding of patient-level data is required. Comorbidities were present in the patient population, including a high incidence of diabetes (59%), chronic kidney disease (44%), and critical limb ischaemia (21%). August 7, 2019 UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality. The Cook analysis of actual treatment of Zilver PTX patients included the updated status for 92% of patients who were previously lost to follow-up. The five-year outcomes indicated that the rates of freedom from target lesion revascularisation were 74.2%, while the clinical benefit indicated for the patient population was 68.2%. 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. Looking for More Information About this Product. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Zilver 635 Vascular Self-Expanding Stent Used as an adjunct to percutaneous transluminal … Available in 80cm and 125cm delivery systems. Nitinol is a mixture of two metals: nickel and titanium. Nitinol makes the Zilver PTX stent open up by itself when your doctor puts it in your artery. The product information on these websites is intended only for licensed physicians and healthcare professionals. Expert opinion: USA.gov. BIBA Medical, North America Stent integrity was assessed by radiography, with site-reported fractures were reviewed by a radiographic core laboratory for classification of fracture type. 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. 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. Zilver Flex is painstakingly electropolished to Cook’s industry leading standards, eliminating the imperfections that can lead to stent fracture. Downloading the Dataset indicates your acceptance of the following Terms and Conditions so long as you retain any of the Dataset, regardless of format or storage method. Request new data that includes lost to follow-up and withdrawn info. Introduction: 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. There was no increased rate of cardiovascular, cancer, or other cause of death for Zilver PTX compared to PTA/BMS. 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. Introduction: In a Cath Lab Digest interview sponsored by Cook Medical, Drs. The findings were presented for the first time at the Cardiovascular and Interventional Radiological Society of Europe 2018 meeting (CIRSE; 22–25 September, Lisbon, Portugal), by Kimihiko Kichikawa, Nara Medical University Hospital, Kashihara, Japan. Patients should be suitable candidates for PTA and/or stent treatment. We share the same concern for patient safety and support the development of peer-reviewed literature that discusses devices used to treat patients suffering from PAD. HHS No express or implied warranties are made with respect to the Dataset by any Cook Medical company, affiliate, or employee. The investigators noted any clinically driven target lesion revascularisation, defined as re-intervention performed for ≥50% diameter stenosis after recurrent clinical symptoms of peripheral arterial disease. Built on Cook’s established line of Zilver stents, the Zilver Vena stent is a flexible, self-expanding stent made with “shape memory” nitinol. 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. 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). The Zilver PTX Drug-Eluting Peripheral Stent is manufactured and distributed by Indiana-based Cook Medical, Inc. The following Terms and Conditions apply for use of the Zilver PTX Randomized Controlled Trial dataset (the “Dataset”). 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. W�IYE�l�E�+(��˙�x��2/�CF��M�&�\�e{�F�r�����۔���۔��>mS^,&��lʋ�7o�N�p�m���t��� ut�s^l�m�ʾ�a˻�e_=��e�>�����9WgxD� �S��f�`r��\�n�*�T�6���[E�b��|��HABd\RGP�-E���t��EQ�����>*��IUf�k����#)r�ڑv��sB���F�*��q?9��]*)�$� ����l����z�)AQ��E���b���P�ȉ���4g�#{�=a�N� Terms and Conditions | Privacy Policy. Get the latest research from NIH: https://www.nih.gov/coronavirus. Allowing public access to the Dataset does not confer any proprietary rights to the data contained therein to third parties. Sign Up. 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 PTX Drug-Eluting Peripheral Stent Indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 7 mm and total lesion lengths up to 300 mm per patient.  |  � Designed for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including the iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulas. Cook Medical is providing our extensive long-term data on Zilver PTX, our drug-eluting stent. Advertising: Shilpa Suthar shilpa@bibamedical.com, United Kingdom: United States: Ut maximus interdum diam et ultrices. Write to us Provided below are links to the selected original Zilver PTX data publications.  |  Get Email about News, Products, and Events from Cook Medical.  |  Dr. Michael Dake et al. Supplied sterile in peel-open packages. National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error. ������ ��@�5L�C����W'�XwxN�� ��h �0T3���xA��֞� ��Y��9����?���D9��D�sM����f�������A� � �4H���=��ﷺ�oH ߢD���?�?������! However, he reiterated that the results of the study continue to show positive long-term outcomes and demonstrate the benefit of the Zilver PTX DES across a broad patient population. Zilver Flex 35 Vascular Self-Expanding Stent. Cook Medical is collaborating with medical societies, physicians, and industry partners to further review patient-level data and present any further findings to FDA and at upcoming industry meetings. TEL: +44 (0)20 7736 8788 DEVICE DESCRIPTION The Zilver® Vascular Stent is a self-expanding stent made of nitinol. Vivamus felis nisl, semper nec pretium sed, dapibus dictum ex. 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. This personal information requested is limited to requester name, hospital/customer affiliation and email address and will be used by Cook Medical in line with its Privacy Policy. Not all products are approved in all regulatory jurisdictions. According to Kichikawa, the use of the Zilver PTX DES (Cook Medical) in treating patients with femoropopliteal lesions have so far elicited favourable outcomes.

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