Design of EverFlex™ Self-expanding Peripheral Stent. By using the site, you consent to the placement of these cookies. Instructions for Use Peak-to-peak connection nodes help to disperse force uniformly among four struts. Update my browser now. PRB35-07-100-120 Protege EverFlex Self-Expanding Peripheral Biliary Stent System. You just clicked a link to go to another website. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6F, 0.035" over-the- CONCLUSION: The high freedom from >50% restenosis and low fracture rate at 12 months suggests that the PROTEGE EverFlex stent offers a safe and acceptably efficacious means of treating SFA lesions in symptomatic subjects with PAD. Three-wave peak design produces expansion force that resists compression and provides excellent wall apposition. The stent is indicated as a palliative treatment of malignant neoplasms in the biliary tree. Fig 1 A, Protégé EverFlex Self-Expanding Peripheral Stent cut in an open lattice design showing spiral cell connectors, three-wave peaks, peak-to-peak connection nodes, and tantalum markers at the proximal and distal ends of the stent; available in stent lengths of 20, 30, 40, 60, 80, 100, 120, 150, and 200 mm. The EverFlex™ self-expanding peripheral stent system (EverFlex stent) is a self-expanding Nitinol stent system intended for permanent implantation. Overview. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations, except those practicing in France as some of the content is not in compliance with the French Advertising law N°2011-2012 dated 29th December 2011, article 34. Each patient received at least one 200-mm-long stent, and the investigator used as few stents as possible to obtain complete lesion coverage. Fig 1. Proprietary deployment system secures the stent to prevent premature deployment or “jumping.”. These stents were selected because of reported patency rates ≥80% at 1 year 7, 20, 21. Healthcare Professionals The stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. All … The entire product line 6 F sheath compatible. Treat lesions in either the SFA, proximal popliteal, subclavian, common and/or external iliac arteries or in the biliary system with confidence, knowing that the DURABILITY trial series demonstrated safety and efficacy of the EverFlex™ stent in complex patient populations. •Received CE Mark for the PROTEGE EverFlex Self-Expanding Stent System for general use in the peripheral vasculature, including common and external iliac, subclavian and the superficial femoral artery on March 9, 2006 •Received FDA approval on March 18, 2008 for a 5mm PROTEGE EverFlex Stent Initial clinical experience with the Protégé EverFlex long self-expanding nitinol stent in the superficial femoral artery. Peripheral and Biliary Stents Peripheral and Biliary Stents The stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. Tantalum markers for enhanced visibility and easier, more precise positioning. U.S. Spiral cell connection pattern enhances flexibility. Duplex ultrasound-assessed patency PSVR 8 cm at Watch an animated demonstration of the features of the Entrust delivery system. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6 F, 0.035” over-the-wire delivery system. Choose the Protégé™ EverFlex™ self-expanding peripheral stent system for its combined benefits of durability and deployment accuracy — all in a broad range of sizes. Update my browser now. The system has the broadest offering of stent lengths: 20 mm - 120 mm. See product catalogue for complete, detailed product information. This site uses cookies to store information on your computer. EverFlex-Self-Expanding Peripheral Stent System Instructions for Use DEVICE DESCRIPTION The EverFlexN Self-Expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. Some are essential to make our site work; others help us improve the user experience. If you continue, you may go to a site run by someone else. The 1-year stent fracture rate was 8.1% (95% CI 4.0% to 14.4%). Flexible design improves fracture resistance and restores vessel patency. In addition to providing a balance of strength and flexibility, the PROTEGE EverFlex provides similar delivery and deployment to the current PROTEGE stent family. Its broad size matrix (20 mm – 200 mm) allows physicians to choose the most appropriate single-stent fit. The Protege® EverFlex® Self-Expanding Biliary Stent System is a self-expanding Nitinol stent system designed for the palliative treatment of malignant neoplasms in the biliary tree. j.ruef@kardiocentrum-ffm.de Protege EverFlex Self-Expanding Stent Covidien and ev3 Inc., www.ev3.net "The stent design and fatigue data generated to date suggest that ev3 has made significant strides in addressing the clinical challenge of stent fracture." The Protégé EverFlex Self-expanding Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree. The BMS used were the Life-Stent (BARD Peripheral Vascular, Inc., Tempe, Arizona), the Protégé EverFlex Stent (ev3 Inc., Plymouth, Minnesota), and the SMART-Control Stent (Cordis Corporation, Johnson & Johnson, Warren, Massachusetts). Read our privacy statement to learn more. With an updated browser, you will have a better Medtronic website experience. Your use of the other site is subject to the terms of use and privacy statement on that site. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6F, 0.035” over-the-wire delivery system. Place the same, trusted stent when your work calls for a 5 mm size in the biliary system by choosing the Protégé™ EverFlex™ self-expanding biliary stent system. The DURABILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Protégé® EverFlex™ and Protégé® GPS™ Self-Expanding Stent Systems for the treatment of atherosclerotic lesions in the common and/or external iliac arteries. PROVIDED PHOTO The 200 mm Protégé EverFlex Stent. Cardiovascular Facebook; Email; Print; Twitter; Pinterest; PROTEGE - EverFlex Self-Expanding Peripheral Stent System - 8mm x 100mm x 120cm EV3. Methods: Patients with lesions >4 cm and <18 cm were enrolled in this nonrandomized, prospective, multicenter trial that evaluated the Protégé EverFlex Self-Expanding Peripheral Stent System (Covidien, Plymouth, Minn). The study's primary end points were the 30-day major adverse event rate and duplex ultrasound-assessed patency at 1 year. Author information: (1)Red Cross Hospital Cardiology Center, Frankfurt, Germany. The Protege® EverFlex® Self-Expanding Biliary Stent System is a self-expanding Nitinol stent system designed for the palliative treatment of malignant neoplasms in the biliary tree. BRIEF STATEMENT. The purpose of this study (superiority trial) is to compare the Supera® Peripheral Stent System with a standard nitinol self-expanding stent for treatment of femoro-popliteal arterial occlusive disease. Home This site uses cookies to store information on your computer. The objective of this clinical investigation is to evaluate the long-term (up to 12 months) outcome of the 200 mm long self-expanding nitinol EverFlex (ev3) stent in long femoropopliteal lesions (TASC C & D) Is is the first time that the use of 200 mm long stents will be evaluated in these lesions. We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. B, A 200-mm stent is depicted. Protege EverFlex. Tantalum GPS markers enhance visibility for easier, more precise positioning. The stent is cut from a Nitinol tube in an The EverFlex™ self-expanding peripheral stent is deliverable through a 6 F catheter. Healthcare Professionals Choose from a full portfolio of peripheral products for endovascular interventions — products that help you reach your PAD patient treatment goals. Stent implantation was performed according to the standard procedures stipulated in the instructions for use available for the Protégé EverFlex stent. The stent is indicated for use in the following types of occlusions or lesions: Stenting is intended to improve and maintain the artery luminal diameter. Three-wave peak design produces expansion force that resists compression and provides excellent wall apposition. Instructions for Use Ruef J(1), Hofmann M, Haase J. In ev3’s rigorous simulated fatigue testing, the Protégé EverFlex survived significantly longer than any competitive stent tested. 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