BRIEF STATEMENT. Spiral cell connection pattern enhances flexibility. 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. With an updated browser, you will have a better Medtronic website experience. The 1-year stent fracture rate was 8.1% (95% CI 4.0% to 14.4%). See product catalogue for complete, detailed product information. This type of stent was placed in the superficial femoral artery of Larry Colgan's thigh to … Find this technical manual in the product labeling supplied with each device or by calling technical support for cardiovascular services: +1 763-526-7890. With an updated browser, you will have a better Medtronic website experience. 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. Peak-to-peak connection nodes help to disperse force uniformly among four struts. The entire product line 6 F sheath compatible. Products The stent is cut from a Nitinol tube in an You may at any time change the settings regarding cookies. U.S. 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. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6F, 0.035" over-the- The stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. Three-wave peak design produces expansion force that resists compression and provides excellent wall apposition. 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. 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. Stents. Healthcare Professionals Products Electromagnetic Compatibility Guide for Cardiac Devices, Minimally Invasive Therapies (formerly Covidien), Information About Proposition 65 for California Customers, California Transparency in Supply Chains Act. 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. Some are essential to make our site work; others help us improve the user experience. Find this technical manual in the product labeling supplied with each device. Tantalum markers for enhanced visibility and easier, more precise positioning. Peripheral and Biliary Stents Update my browser now. Fig 1. Occlusions or lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA), Lesions that appear to be at high risk for restenosis following PTA in the common iliac, external iliac, superficial femoral, proximal popliteal, or subclavian arteries. Each patient received at least one 200-mm-long stent, and the investigator used as few stents as possible to obtain complete lesion coverage. A655848 EXP-2021-06-04 size 7mm 100mm 120mm .035" 6F OTW 5.5-6.5mm Lumen diameter Shipping to Worldwide cost price $21 please use for payment PAYPAL DISCLAIMER: The stent is mounted on a traditional "pin-pull" style delivery system. Click “OK” to confirm you are a Healthcare Professional. Initial clinical experience with the Protégé EverFlex long self-expanding nitinol stent in the superficial femoral artery. Instructions for Use The EverFlex™ Self-Expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. Protege EverFlex Self-Expanding Stent Covidien and ev3 Inc., www.ev3.net Healthcare Professionals Read our privacy statement to learn more. Flexible design improves fracture resistance and restores vessel patency. Stent implantation was performed according to the standard procedures stipulated in the instructions for use available for the Protégé EverFlex stent. Choose from a full portfolio of peripheral products for endovascular interventions — products that help you reach your PAD patient treatment goals. Tantalum markers for enhanced visibility and easier, more precise positioning. PROTEGE - EverFlex Self-Expanding Peripheral Stent System - 8mm x 100mm x 120cm. 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 for use in the following types of occlusions or lesions: Stenting is intended to improve and maintain the artery luminal diameter. Some are essential to make our site work; others help us improve the user experience. By using the site, you consent to the placement of these cookies. These stents were selected because of reported patency rates ≥80% at 1 year 7, 20, 21. Deliver the same, trusted Protégé™ EverFlex™ stent with the ease of single handed deployment when choosing the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system to treat PAD in the SFA, proximal popliteal, subclavian, and common or external iliac arteries. It is possible that some of the products on the other site are not approved in your region or country. The system has the broadest offering of stent lengths: 20 mm - 120 mm. 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 Read our privacy statement to learn more. The Protégé EverFlex Self-expanding Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree. 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 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. In addition to providing a balance of strength and flexibility, the PROTEGE EverFlex provides similar delivery and deployment to the current PROTEGE stent family. 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 study's primary end points were the 30-day major adverse event rate and duplex ultrasound-assessed patency at 1 year. "The stent design and fatigue data generated to date suggest that ev3 has made significant strides in addressing the clinical challenge of stent fracture." You may at any time change the settings regarding cookies. The EverFlex™ self-expanding peripheral stent is deliverable through a 6 F catheter. This site uses cookies to store information on your computer. Peak-to-peak connection nodes help to disperse force uniformly among four struts. •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 This site uses cookies to store information on your computer. Overview. Indication: The EverFlex™ self-expanding peripheral stent system is intended to improve luminal diameter in the treatment of symptamotic de novo or restenotic lesions up to 180 mm in length in the native superficial femoral artery and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 mm – 7.5 mm. Update my browser now. 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. Duplex ultrasound-assessed patency PSVR 8 cm at Watch an animated demonstration of the features of the Entrust delivery system. Flexible design improves fracture resistance and restores vessel patency. By using the site, you consent to the placement of these cookies. B, A 200-mm stent is depicted. Choose from a full portfolio of peripheral products for endovascular interventions — products that help you reach your PAD patient treatment goals. Its broad size matrix (20 mm – 200 mm) allows physicians to choose the most appropriate single-stent fit. 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. 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 the Protégé™ EverFlex™ self-expanding peripheral stent system for its combined benefits of durability and deployment accuracy — all in a broad range of sizes. Three-wave peak design produces expansion force that resists compression and provides excellent wall apposition. Protégé EverFlex Self-expanding Biliary Stent With an updated browser, you will have a better Medtronic website experience. 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). 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. All … 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). Design of EverFlex™ Self-expanding Peripheral Stent. Home j.ruef@kardiocentrum-ffm.de The EverFlex™ self-expanding peripheral stent system (EverFlex stent) is a self-expanding Nitinol stent system intended for permanent implantation. If you continue, you may go to a site run by someone else. The Protégé EverFlex Self-Expanding Stent System employs the latest nitinol self-expanding stent technology to provide previously undemon-strated durability. 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 stent is indicated as a palliative treatment of malignant neoplasms in the biliary tree. Protégé EverFlex, Protégé™ EverFlex™ Self-expanding Peripheral and Biliary Stent. Peripheral and Biliary Stents Cardiovascular PROVIDED PHOTO The 200 mm Protégé EverFlex Stent. The EverFlex stent has been available in the United States since February 2006 for the palliative treatment of malignant neoplasms in the biliary tree. Indications The Protégé EverFlex Self-expanding Biliary Stent System is intended as a palliative treatment of malignant neoplasms in … Cardiovascular The stent is indicated as a palliative treatment of malignant neoplasms in the biliary tree. Ruef J(1), Hofmann M, Haase J. 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. You just clicked a link to go to another website. In ev3’s rigorous simulated fatigue testing, the Protégé EverFlex survived significantly longer than any competitive stent tested. B, A 200-mm stent is depicted. The stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. AccessGUDID - EverFlex™ Protégé™ EverFlex™ (00821684059852)- STENT PRB35-06-030-080 PROTEGE EF V07 Proprietary deployment system secures the stent to prevent premature deployment or “jumping.”. Author information: (1)Red Cross Hospital Cardiology Center, Frankfurt, Germany. Facebook; Email; Print; Twitter; Pinterest; PROTEGE - EverFlex Self-Expanding Peripheral Stent System - 8mm x 100mm x 120cm EV3. PRB35-07-100-120 Protege EverFlex Self-Expanding Peripheral Biliary Stent System. Spiral cell connection pattern enhances flexibility. 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. 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