Duplex ultrasound-assessed patency PSVR 8 cm at Watch an animated demonstration of the features of the Entrust delivery system. These stents were selected because of reported patency rates ≥80% at 1 year 7, 20, 21. Update my browser now. All indications related to the Protégé™ EverFlex™ Self-expanding Peripheral and Biliary Stent are not approved globally, please refer to the complete Instructions for Use manual for the indication for Use approved in your geography. The stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. 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. 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. The study's primary end points were the 30-day major adverse event rate and duplex ultrasound-assessed patency at 1 year. The Protégé EverFlex Self-Expanding Stent System employs the latest nitinol self-expanding stent technology to provide previously undemon-strated durability. Update my browser now. The system has the broadest offering of stent lengths: 20 mm - 120 mm. Three-wave peak design produces expansion force that resists compression and provides excellent wall apposition. Proprietary deployment system secures the stent to prevent premature deployment or “jumping.”. 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 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). Protégé EverFlex Self-expanding Biliary Stent With an updated browser, you will have a better Medtronic website experience. Instructions for Use All … Home Home Flexible design improves fracture resistance and restores vessel patency. It is possible that some of the products on the other site are not approved in your region or country. Ruef J(1), Hofmann M, Haase J. 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. Healthcare Professionals PROTEGE - EverFlex Self-Expanding Peripheral Stent System - 8mm x 100mm x 120cm. Click “OK” to confirm you are a Healthcare Professional. Read our privacy statement to learn more. Spiral cell connection pattern enhances flexibility. Peripheral and Biliary Stents Its broad size matrix (20 mm – 200 mm) allows physicians to choose the most appropriate single-stent fit. "The stent design and fatigue data generated to date suggest that ev3 has made significant strides in addressing the clinical challenge of stent fracture." Peripheral and Biliary Stents 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. 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. Fig 1. The stent is mounted on a traditional "pin-pull" style delivery system. Tantalum markers for enhanced visibility and easier, more precise positioning. By using the site, you consent to the placement of these cookies. 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. Electromagnetic Compatibility Guide for Cardiac Devices, Minimally Invasive Therapies (formerly Covidien), Information About Proposition 65 for California Customers, California Transparency in Supply Chains Act. Peak-to-peak connection nodes help to disperse force uniformly among four struts. This site uses cookies to store information on your computer. 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. Products 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. [email protected] By using the site, you consent to the placement of these cookies. 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. Biotronik, Inc. Pulsar-18 Nitinol: 4: 0.018: 4–7: 20–150: 90, 135: Indicated for use to improve luminal diameter in patients with symptomatic de novo, restenotic, or occlusive lesions located in the superficial femoral or proximal popliteal arteries, with reference vessel diameters from 3–6 mm and total lesion lengths up to 190 mm Cardiovascular In ev3’s rigorous simulated fatigue testing, the Protégé EverFlex survived significantly longer than any competitive stent tested. Protégé EverFlex, Protégé™ EverFlex™ Self-expanding Peripheral and Biliary Stent. Design of EverFlex™ Self-expanding Peripheral Stent. 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. PROVIDED PHOTO The 200 mm Protégé EverFlex Stent. Stents. U.S. If you continue, you may go to a site run by someone else. Some are essential to make our site work; others help us improve the user experience. You may at any time change the settings regarding cookies. B, A 200-mm stent is depicted. This type of stent was placed in the superficial femoral artery of Larry Colgan's thigh to … 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. The EverFlex™ self-expanding peripheral stent system (EverFlex stent) is a self-expanding Nitinol stent system intended for permanent implantation. The Protégé EverFlex Self-expanding Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree. Each patient received at least one 200-mm-long stent, and the investigator used as few stents as possible to obtain complete lesion coverage. Cardiovascular Peak-to-peak connection nodes help to disperse force uniformly among four struts. Find this technical manual in the product labeling supplied with each device. 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. Instructions for Use Products See product catalogue for complete, detailed product information. 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. With an updated browser, you will have a better Medtronic website experience. •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 The stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. Tantalum GPS markers enhance visibility for easier, more precise positioning. In addition to providing a balance of strength and flexibility, the PROTEGE EverFlex provides similar delivery and deployment to the current PROTEGE stent family. Facebook; Email; Print; Twitter; Pinterest; PROTEGE - EverFlex Self-Expanding Peripheral Stent System - 8mm x 100mm x 120cm EV3. You may at any time change the settings regarding cookies. 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. Purpose: To evaluate the long-term efficacy and integrity of the PROTEGE EverFlex stent in superficial femoral artery (SFA) lesions in symptomatic patients with peripheral artery disease (PAD). The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6F, 0.035" over-the- The EverFlex stent has been available in the United States since February 2006 for the palliative treatment of malignant neoplasms in the biliary tree. Protege EverFlex Self-Expanding Stent Covidien and ev3 Inc., www.ev3.net The 1-year stent fracture rate was 8.1% (95% CI 4.0% to 14.4%). The EverFlex self-expanding stent system is a nitinol stent system that expands to a predetermined diameter to re-open narrowed (stenotic) regions of the SFA and proximal popliteal arteries that supply blood to the legs. The EverFlex™ Self-Expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. 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. Three-wave peak design produces expansion force that resists compression and provides excellent wall apposition. 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. The stent is indicated as a palliative treatment of malignant neoplasms in the biliary tree. Protege EverFlex. Choose from a full portfolio of peripheral products for endovascular interventions — products that help you reach your PAD patient treatment goals. Overview. B, A 200-mm stent is depicted. Author information: (1)Red Cross Hospital Cardiology Center, Frankfurt, Germany. Flexible design improves fracture resistance and restores vessel patency. 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. The stent is indicated as a palliative treatment of malignant neoplasms in the biliary tree. The EverFlex™ self-expanding peripheral stent is deliverable through a 6 F catheter. 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