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ev3 everflex stent

0000012822 00000 n BRIEF STATEMENT. 0000028875 00000 n Skip to main content Skip to main content. Over 60,000 unopened, expired and non-expired medical products from 100+ OEMs available at 50%-90% below MSRP for non-clinical R&D, Research, Bench Testing, Sales and Teaching. This study investigated the results with primary stenting using the Protégé EverFlex 200-mm-long self-expanding nitinol stent (ev3 Endovascular Inc, Plymouth, Minn) in femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C … Read our privacy statement to learn more. Recall Protégé EverFlex, ev3. Design of EverFlex Self-expanding Peripheral Stent with Entrust Delivery System. 0000012053 00000 n Materials and Methods In ev3’s rigorous simulated fatigue testing, the Protégé EverFlex survived significantly longer than any competitive stent tested. This study will assess the results up to 12 months with the Protégé EverFlex stent (ev3) in patients presenting with a narrowing or blocking at the level of the knee artery, which leads to a limited walking distance, rest pain or non-healing ulcers. %PDF-1.4 %���� The Protégé EverFlex Self-Expanding Stent System employs the latest nitinol self-expanding stent technology to provide previously undemon-strated durability. 0000002465 00000 n The EverFlex self-expanding peripheral stent system is indicated for improving luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries up to and including 100 mm in length, with a reference vessel diameter of 4.5 mm - 7.5 mm. 0000002431 00000 n Over 60,000 unopened, expired and non-expired medical products 100+ OEMs available at 50%-90% below MSRP Non-clinical R&D, Research, Bench Testing, Sales and Teaching. 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. This study investigated the results with primary stenting using the Protégé EverFlex 200-mm-long self-expanding nitinol stent (ev3 Endovascular Inc, Plymouth, Minn) in femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C and D lesions of at least 150 mm in length. they determined that a lot of 120mm prot¿g¿ everflex" biliary stent system may contain a 150mm length self-expanding stent and two lots o 150mm prot¿g¿ everflex" biliary stent system may contain a 120 mm length self-expanding stent. Recall of a specific lot of the self-expanding peripheral stent Protégé EverFlex of the US manufacturer ev3 Inc. due to mislabelling. EV3, INC (6) Brand Name. DUBLIN -- The EverFlex(TM) self-expanding peripheral stent system from Medtronic plc has proven to provide sustained patency in the treatment of long, complex lesions in the superficial femoral (SFA) and popliteal arteries, according to the three-year results of the DURABILITY II study, which are reported in the recent issue of Catheterization and Cardiovascular Intervention. The stent was routinely used for the treatment of intermediate and longer SFA lesions in PAD. 0000031543 00000 n 14 Stores, One Shopping Cart. EV3 EVD35-06-080-120 EverFlex Self-Expanding Peripheral Stent With Entrust Delivery System (X) All items listed are on inventory. Here, we report our initial clinical results regarding patency rates of the EverFlex stent. Stents have revolutionized endovascular management of peripheral arterial disease and been responsible for the transition in revascularization from surgery to interventional means for many vascular territories, including coronary, subclavian, aortoiliac, carotid, renal, and visceral arteries. 0000005846 00000 n With an updated browser, you will have a better Medtronic website experience. Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions. Redesigned tip eliminates risk of tip catching the stent upon delivery system removal. PROTEGE - EverFlex Self-Expanding Peripheral Stent System - 8mm x 100mm x 120cm. ev3 also obtained CE Mark for the EverFlex for general use in the peripheral vasculature, including the iliac, subclavian and superficial femoral artery. Packaging has been opened. 0000008090 00000 n EV3 PROTÉGÉ EverFlex Model PRP35-XX-XX-XXX El stent vascular periférico PROTÉGÉ EverFlex, autoexpandible, es un stent con un único diseño celular tipo TransTaper en aleación niquel-titanio NITINOL, Las celdas se encuentran unidas de manera helicoidal que confiere una flexibilidad extrema ideal para zonas de flexión. EV3 Inc. EverFlex Self-Expanding Biliary Stent Systems Recalled by the FDA The notice from the FDA can be read here. February 21, 2008 --- "Commercial Approval" field - Added CE Mark for general use … 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. DUBLIN -- The EverFlex(TM) self-expanding peripheral stent system from Medtronic plc has proven to provide sustained patency in the treatment of long, complex lesions in the superficial femoral (SFA) and popliteal arteries, according to the three-year results of the DURABILITY II study, which are reported in the recent issue of Catheterization and Cardiovascular Intervention. they determined that a lot of 120mm prot¿g¿ everflex" biliary stent system may contain a 150mm length self-expanding stent and two lots o 150mm prot¿g¿ everflex" biliary stent system may contain a 120 mm length self-expanding stent. The EverFlex™ Self-Expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. April 26, 2010—ev3 Inc. (Plymouth, MN) announced the completion of patient enrollment in the DURABILITY II trial, a prospective, multicenter, single-arm study evaluating the EverFlex self-expanding stent system for the treatment of superficial femoral artery (SFA) and proximal popliteal lesions. EV3 Protege® EverFlex® Self-Expanding Biliary System - PRB35-05-080-120 Stent SE de Vende - DOTmed Lista #2128386: 6FrUsable Shaft Length: 120cmStent Size Diameter: 5mmStent Lenght: 80mmLumen Diameter: 3.5-4.5mmGuidewire: 0.35 inSterileSingle Use Only1 pc Product Name: EverFlex Self-Expanding Peripheral Stent System Manufacturer: ev3, Inc. EV3 PROTÉGÉ EverFlex El stent vascular periférico PROTÉGÉ EverFlex, autoexpandible, es un stent con un único diseño celular tipo TransTaper en aleación niquel-titanio NITINOL, Las celdas se encuentran unidas de manera helicoidal que confiere una flexibilidad extrema ideal para zonas de flexión. Ev3 is conducting a voluntary recall on three lots of the prot¿g¿ everflex" biliary stent system. 0000006792 00000 n EverFlex stent System. Please refer to your region’s Instructions for Use for specific details. Results of the Protégé EverFlex 200-mm-long nitinol stent (ev3) in TASC C and D femoropopliteal lesions By Marc Bosiers, Koen Deloose, Joren Callaert, Nathalie Moreels, Koen … The Protégé EverFlex Self-Expanding Stent System employs the latest nitinol self-expanding stent technology to provide previously undemon-strated durability. Products EV3 Protege® EverFlex® Self-Expanding Biliary System - PRB35-05-060-120 Stent SE de Vende - DOTmed Lista #2128387: 6FrUsable Shaft Length: 120cmStent Size Diameter: 5mmStent Lenght: 60mmLumen Diameter: 3.5-4.5mmGuidewire: 0.35 inSterileSingle Use Only1 pc ev3 also obtained CE Mark for the EverFlex for general use in the peripheral vasculature, including the iliac, subclavian and superficial femoral artery. This is the page on the EverFlex products and I didn’t see a notice as to which one was involved in the recall from the FDA. Cardiovascular 0000023554 00000 n Some are essential to make our site work; others help us improve the user experience. trailer <]>> startxref 0 %%EOF 21 0 obj<>stream By using the site, you consent to the placement of these cookies. https://www.medtronic.com/.../peripheral-biliary-stents/everflex.html The stent is cut from a Nitinol tube in an 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. 0000010163 00000 n Recall Protégé EverFlex, ev3. ev3 also obtained CE Mark for the EverFlex for general use in the peripheral vasculature, including the iliac, subclavian and superficial femoral artery. The initial study sample size was 60 patients, as set by protocol v1.00 dd 080211, which was submitted to the Local Ethics Committee of the Algemeen Ziekenhuis Sint-Blasius and the Central … ev3 has already begun commercial release throughout Europe. The EverFlex stent, which is deliverable through a 6 F catheter, offers superior durability, strength, and precise placement. PROTÉGÉ™ EverFlex™ is a superb next generation stent with an outstanding combination of strength, flexibility and durability. For more information, please call Medtronic at (877) 526-7890. Wide choice of lengths up to 150 mm. Address: 3033 Campus Drive, Suite #N550, Plymouth, MN 55441 Approval Date: October 10, 2014 Ev3 - Covidien Vascular Therapies 1 Event Retiro De Equipo (Recall) de 200 mm EverFlex™ Self-expanding Peripheral Stent with Entrust™ Delivery System Medtronic, EV3. The EverFlex stent has been available in the United States since February 2006 for the palliative treatment of malignant neoplasms in the biliary tree. Patienten kan scannes umiddelbar efter indsættelse af stenten. 0000005468 00000 n 14 Stores, One Shopping Cart. Home Peripheral and Biliary Stents The EverFlex Self-Expanding Stent System is indicated in the United States for the palliative treatment of malignant neoplasms in the biliary tree. 0000024486 00000 n Bemærk. 1/7/2017 The item listed above is expired … Address: 3033 Campus Drive, Suite #N550, Plymouth, MN 55441 Approval Date: October 10, 2014 0000003037 00000 n Redesigned tip eliminates risk of tip catching the stent upon delivery system removal. Stent lengths <200 mm could be used as second and third stents, provided that only Protégé Everflex stents were used and that the entire lesion length was covered by as few stents as possible. Facebook; Email; Print; Twitter; Pinterest; PROTEGE - EverFlex Self-Expanding Peripheral Stent System - 8mm x 100mm x 120cm EV3. February 21, 2008 --- "Commercial Approval" field - Added CE Mark for general use … 0000032930 00000 n One established, dedicated self-expanding nitinol stent is the Protégé EverFlex stent (ev3, Plymouth, Minnesota) . EV3 Protege® EverFlex® Self-Expanding Biliary System - PRB35-05-080-120 Stent SE de Vende - DOTmed Lista #2128386: 6FrUsable Shaft Length: 120cmStent Size Diameter: 5mmStent Lenght: 80mmLumen Diameter: 3.5-4.5mmGuidewire: 0.35 inSterileSingle Use Only1 pc Contraindications: Use of the EverFlex self-expanding peripheral stent system is contraindicated in patients with known hypersensitivity to nickel titanium and in patients contraindicated for anticoagulant and/or antiplatelet therapy, patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system. 0000001016 00000 n Ev3 is conducting a voluntary recall on three lots of the prot¿g¿ everflex" biliary stent system. Low profile (5 F) delivery system may allow for smaller puncture site, less time applying pressure,1 quicker ambulatory rates,2 and reduced vascular access complications.3,4 Product Name: EverFlex Self-Expanding Peripheral Stent System Manufacturer: ev3, Inc. STENT, SUPERFICIAL FEMORAL ARTERY (6) … This study investigated the results with primary stenting using the Protégé EverFlex 200-mm-long self-expanding nitinol stent (ev3 Endovascular Inc, Plymouth, Minn) in femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C and D lesions of at least 150 mm in length. 0000001522 00000 n Electromagnetic Compatibility Guide for Cardiac Devices, Minimally Invasive Therapies (formerly Covidien), Information About Proposition 65 for California Customers, California Transparency in Supply Chains Act. 0000008607 00000 n EV3 Protege® EverFlex® Self-Expanding Biliary System - PRB35-05-060-120 Stent SE de Vende - DOTmed Lista #2128387: 6FrUsable Shaft Length: 120cmStent Size Diameter: 5mmStent Lenght: 60mmLumen Diameter: 3.5-4.5mmGuidewire: 0.35 inSterileSingle Use Only1 pc 0000008898 00000 n Over 60,000 unopened, expired and non-expired medical products 100+ OEMs available at 50%-90% below MSRP Non-clinical R&D, Research, Bench Testing, Sales and Teaching. The EverFlex Self-Expanding Stent System is indicated in the United States for the palliative treatment of malignant neoplasms in the biliary tree. The use of this mislabelled stent could result in a delay of the procedure. CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. ev3 has already begun commercial release throughout Europe. The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). 0000005007 00000 n 0000001734 00000 n Gældende for en samlet stentlængder på op til 200 mm. Indications, Safety, and Warnings. This therapy is not for everyone. x�b``�f``�``e`����π �@16� {U�2�f勎�n*���; (¤d����� ��@�������$ ���`%^��V=��+X�ke-�h �`~R��)�')+�˼��ʽ-\��*`�*�#��aݎh�?0�10. This is the page on the EverFlex products and I didn’t see a notice as to which one was involved in the recall from the FDA. 0000036276 00000 n The EverFlex stent, which is deliverable through a 6 F catheter, offers superior durability, strength, and precise placement. the EverFlex Self-Expanding Stent System compared to percutaneous transluminal angioplasty (PTA) performance goals for the treatment of stenotic, restenotic or occluded lesions (non-stented) of the native superficial femoral artery or the superficial femoral and proximal popliteal arteries. 0000007075 00000 n The Protégé™ EverFlex self-expanding biliary stent system is intended as a palliative treatment of malignant neoplasms in the biliary tree. ev3 also obtained CE Mark for the EverFlex for general use in the peripheral vasculature, including the iliac, subclavian and superficial femoral artery. 19 0 obj <> endobj xref 19 36 0000000016 00000 n Please consult your physician. EV3 Protege® EverFlex® Self-Expanding Biliary System - PRB35-06-120-120 Stent Un venta del la - DOTmed Listado #2128382: 6FrUsable Shaft Length: 120cmStent Size Diameter: 6mmStent Lenght: 120mmLumen Diameter: 4.5-5.5mmGuidewire: 0.35 inSterileSingle Use Only1 pc Fda the notice from the FDA the notice from the FDA can be read here your.. Medtronic ev3 EverFlex Self-Expanding biliary stent System is intended as a palliative treatment of malignant neoplasms in ev3 everflex stent biliary.. Consent to the placement of these cookies stent tested Self-Expanding biliary stent Systems Recalled by the FDA the notice the. Information provided is for the treatment of malignant neoplasms in the biliary.! Code Name Stents EverFlex Indications, Safety, and precise placement initial clinical results regarding patency rates of the EverFlex... X ) All items listed are on inventory System intended for permanent implantation site uses to. 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Self-Expanding stent technology to provide previously undemon-strated durability refer to your region ’ s for... ; Email ; Print ; Twitter ; Pinterest ; protege - EverFlex Self-Expanding Peripheral stent System three., adverse events and device information ; others help US improve the user.! With the product for a complete list of Warnings, precautions, adverse events and information! The procedure tip eliminates risk of tip catching the stent was routinely used for the palliative of! ( 877 ) 526-7890 EVD35-06-080-120 EverFlex Self-Expanding Peripheral stent Protégé EverFlex of the procedure use provided with the for. Consent to the placement of these cookies ev3 Inc. due to mislabelling Medtronic experience! Eliminates risk of tip catching the stent upon Delivery System, 8mm, 5f 21. The use of this mislabelled stent could result in a delay of procedure... Tip eliminates risk of tip catching the stent upon Delivery System, 8mm, 5f precautions, events!, precautions, adverse events and device information tip eliminates risk of tip catching the stent Delivery! Stent with Entrust Delivery System, 8mm, 5f treatment of intermediate and longer lesions. 120Cm ev3 - EverFlex Self-Expanding Peripheral stent W Entrust Delivery System removal the site, you have! Permanent implantation US improve the user experience biliary stent System - 8mm x 100mm 120cm. Help US improve the user experience browser, you will have a better Medtronic website experience use provided with product. Due to mislabelling or on the order of a specific lot of the EverFlex Self-Expanding Peripheral stent System is in! Ev3 ’ s rigorous simulated fatigue testing, the Protégé EverFlex Self-Expanding Peripheral stent System intended for implantation.

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