The use of this mislabelled stent could result in a delay of the procedure. The Protégé EverFlex Self-Expanding Stent System employs the latest nitinol self-expanding stent technology to provide previously undemon-strated durability. 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. Recall of a specific lot of the self-expanding peripheral stent Protégé EverFlex of the US manufacturer ev3 Inc. due to mislabelling. 0000005007 00000 n Protege EverFlex Self-Expanding Stent Covidien and ev3 Inc., www.ev3.net New EV3 PRB35-06-040-080 EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM: 6MM X 40MM X 80CM Disposables - General Un venta del la - DOTmed Listado #2562334: ITEM FOR SALE: EV3 PRB35-06-040-080 EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM: 6MM X 40MM X 80CM Item is new in box. In ev3’s rigorous simulated fatigue testing, the Protégé EverFlex survived significantly longer than any competitive stent tested. 0000012053 00000 n x�b``�f``�``e`����π �@16� {U�2�f勎�n*���; (¤d����� ��@�������$ ���`%^��V=��+X�ke-�h �`~R��)�')+�˼��ʽ-\��*`�*�#��aݎh�?0�10. The spiral-cell connection and peak-to-peak connection nodes are designed to disperse force uniformly, while the three-wave peak design resists compression and … Pheripheral and Biliary 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. 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. Design of EverFlex Self-expanding Peripheral Stent with Entrust Delivery System. %PDF-1.4 %���� Bemærk. 0000031543 00000 n 0000001263 00000 n 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 … Cardiovascular 0000024486 00000 n 0000005846 00000 n 0000002961 00000 n 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. The EverFlex stent has been available in the United States since February 2006 for the palliative treatment of malignant neoplasms in the biliary tree. 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 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. EverFlex stent System. Multiple peripheral artery stent, bare-metal (6) FDA Product Code Name. 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. Gældende for en samlet stentlængder på op til 200 mm. Additionally, ev3 obtained 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. The stent was routinely used for the treatment of intermediate and longer SFA lesions in PAD. The spiral-cell connection and peak-to-peak connection nodes are designed to disperse force uniformly, while the three-wave peak design resists compression and … 0000001343 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. 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 EverFlex™ Self-Expanding Peripheral Stent System"; ev3 Inc., February 21, 2008. 0000012822 00000 n ev3 also obtained CE Mark for the EverFlex for general use in the peripheral vasculature, including the iliac, subclavian and superficial femoral artery. EverFlex™ Protégé™ EverFlex™ (6) GMDN Term. The EverFlex Self-Expanding Stent System is indicated in the United States for the palliative treatment of malignant neoplasms in the biliary tree. 0000003037 00000 n Products Potential Adverse Events: Potential adverse events which may be associated with the use of a stent in the SFA and proximal popliteal arteries include, but are not limited to: Allergic reaction, Amputation, Artery perforation or rupture, Bleeding requiring transfusion, Infection, Pseudoaneurysm, Restenosis, Stent collapse or fracture, Stent migration, Surgical or endovascular intervention, Thrombosis/occlusion of the stent. Product Name: EverFlex Self-Expanding Peripheral Stent System Manufacturer: ev3, Inc. 0000032930 00000 n 0000009201 00000 n Please refer to your region’s Instructions for Use for specific details. PROTEGE - EverFlex Self-Expanding Peripheral Stent System - 8mm x 100mm x 120cm. 0000010163 00000 n This therapy is not for everyone. The EverFlex Self-Expanding Stent System is indicated in the United States for the palliative treatment of malignant neoplasms in the biliary tree. 0000003111 00000 n PROTÉGÉ™ EverFlex™ is a superb next generation stent with an outstanding combination of strength, flexibility and durability. ev3 also obtained CE Mark for the EverFlex for general use in the peripheral vasculature, including the iliac, subclavian and superficial femoral artery. 0000036276 00000 n 0000023554 00000 n The Protégé™ EverFlex self-expanding biliary stent system is intended as a palliative treatment of malignant neoplasms in the biliary tree. 14 Stores, One Shopping Cart. 0000005523 00000 n Ev3 is conducting a voluntary recall on three lots of the prot¿g¿ everflex" biliary stent system. 0000004038 00000 n Some are essential to make our site work; others help us improve the user experience. Skip to main content Skip to main content. A prescription is required. 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. ev3 has already begun commercial release throughout Europe. This site uses cookies to store information on your computer. 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 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. With an updated browser, you will have a better Medtronic website experience. February 21, 2008 --- "Commercial Approval" field - Added CE Mark for general use … 0000008898 00000 n Facebook; Email; Print; Twitter; Pinterest; PROTEGE - EverFlex Self-Expanding Peripheral Stent System - 8mm x 100mm x 120cm EV3. Address: 3033 Campus Drive, Suite #N550, Plymouth, MN 55441 Approval Date: October 10, 2014 Visit all our stores. 0000002465 00000 n Clinical Relevance. 19 0 obj <> endobj xref 19 36 0000000016 00000 n STENT, SUPERFICIAL FEMORAL ARTERY (6) … Objectives. AccessGUDID - EverFlex™ Protégé™ EverFlex™ (00821684059852)- STENT PRB35-06-030-080 PROTEGE EF V07 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 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 … 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. Wide choice of lengths up to 150 mm. In ev3’s rigorous simulated fatigue testing, the Protégé EverFlex survived significantly longer than any competitive stent tested. 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 Address: 3033 Campus Drive, Suite #N550, Plymouth, MN 55441 Approval Date: October 10, 2014 The EverFlex Self-Expanding Stent System is indicated in the United States for the palliative treatment of malignant neoplasms in the biliary tree. Recall Protégé EverFlex, ev3. It resists fracturing under demanding conditions. One established, dedicated self-expanding nitinol stent is the Protégé EverFlex stent (ev3, Plymouth, Minnesota) . Read our privacy statement to learn more. Recall Protégé EverFlex, ev3. 0000001522 00000 n Please consult your physician. CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. 14 Stores, One Shopping Cart. 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. Redesigned tip eliminates risk of tip catching the stent upon delivery system removal. Patienten kan scannes umiddelbar efter indsættelse af stenten. trailer <]>> startxref 0 %%EOF 21 0 obj<>stream The stent is cut from a Nitinol tube in an 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. 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. Home 0000008353 00000 n 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. The EverFlex™ self-expanding peripheral stent system (EverFlex stent) is a self-expanding Nitinol stent system intended for permanent implantation. Additionally, ev3 obtained 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. EV3 EVD35-06-080-120 EverFlex Self-Expanding Peripheral Stent With Entrust Delivery System (X) All items listed are on inventory. 0000014166 00000 n Description: EXP. 0000002431 00000 n EV3 Inc. EverFlex Self-Expanding Biliary Stent Systems Recalled by the FDA The notice from the FDA can be read here. 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 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. Materials and Methods EverFlex™ Self-Expanding Peripheral Stent System"; ev3 Inc., February 21, 2008. EV3 Inc. EverFlex Self-Expanding Biliary Stent Systems Recalled by the FDA The notice from the FDA can be read here. Ev3 - Covidien Vascular Therapies 1 Event Retiro De Equipo (Recall) de 200 mm EverFlex™ Self-expanding Peripheral Stent with Entrust™ Delivery System 0000028875 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. Recall of a specific lot of the self-expanding peripheral stent Protégé EverFlex of the US manufacturer ev3 Inc. due to mislabelling. 0000007075 00000 n Redesigned tip eliminates risk of tip catching the stent upon delivery system removal. 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 … The EverFlex™ Self-Expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. 0000001734 00000 n 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. For more information, please call Medtronic at (877) 526-7890. Indications, Safety, and Warnings. The Protégé EverFlex Self-Expanding Stent System employs the latest nitinol self-expanding stent technology to provide previously undemon-strated durability. Product Name: EverFlex Self-Expanding Peripheral Stent System Manufacturer: ev3, Inc. Medtronic Ev3 Everflex Self-Expanding Peripheral Stent W Entrust Delivery System, 8mm, 5f. 0000006792 00000 n The EverFlex Self-Expanding Stent System is indicated in the United States for the palliative treatment of malignant neoplasms in the biliary tree. February 21, 2008 --- "Commercial Approval" field - Added CE Mark for general use … Medtronic, EV3. 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. 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). The use of this mislabelled stent could result in a delay of the procedure. You may at any time change the settings regarding cookies. 1/7/2017 The item listed above is expired … ev3 has already begun commercial release throughout Europe. 0000001016 00000 n BRIEF STATEMENT. Design of EverFlex Self-expanding Peripheral Stent with Entrust Delivery System. 0000032684 00000 n See the Instructions for Use provided with the product for a complete list of warnings, precautions, adverse events and device information. 0000005468 00000 n https://www.medtronic.com/.../peripheral-biliary-stents/everflex.html 0000008090 00000 n EV3, INC (6) Brand Name. Here, we report our initial clinical results regarding patency rates of the EverFlex stent. The EverFlex stent, which is deliverable through a 6 F catheter, offers superior durability, strength, and precise placement. EverFlex Healthcare Professionals Update my browser now. 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. Gældende for enkelt-stents samt overlappende stentkonfigurationer på op til 200 mm. 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 ev3 also obtained CE Mark for the EverFlex for general use in the peripheral vasculature, including the iliac, subclavian and superficial femoral artery. 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. Peripheral and Biliary Stents By using the site, you consent to the placement of these cookies. Packaging has been opened. Note: Safety information provided is for the United States. The EverFlex stent, which is deliverable through a 6 F catheter, offers superior durability, strength, and precise placement. 0000011131 00000 n 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. 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. ev3 also obtained CE Mark for the EverFlex for general use in the peripheral vasculature, including the iliac, subclavian and superficial femoral artery. 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. 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. 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. Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions. 0000008607 00000 n 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 0000021798 00000 n Ev3 is conducting a voluntary recall on three lots of the prot¿g¿ everflex" biliary stent system. The EverFlex stent has been available in the United States since February 2006 for the palliative treatment of malignant neoplasms in the biliary tree. System - 8mm x 100mm x 120cm ev3 ; Email ; Print ; Twitter Pinterest...: Federal ( USA ) law restricts these devices to sale by on. You may at any time change the settings regarding cookies, we report our initial clinical regarding. 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System removal read here Medtronic ev3 EverFlex Self-Expanding biliary stent System is intended as a palliative treatment intermediate. With Entrust Delivery System, 8mm, 5f System manufacturer: ev3,.. Results regarding patency rates of the Self-Expanding Peripheral stent System EverFlex of the prot¿g¿ EverFlex biliary... System - 8mm x 100mm x 120cm Medtronic at ( 877 ) 526-7890 Pinterest ; protege - EverFlex biliary. Use for specific details the product for a complete list of Warnings, precautions, adverse events and device.. ( USA ) law restricts these devices to sale by or on the order a. Of a specific lot of the procedure s Instructions for use for specific details at any time change the regarding... Competitive stent tested stentlængder på op til 200 mm the latest nitinol Self-Expanding System... And biliary Stents EverFlex Indications, Safety, and precise placement call Medtronic at ( )... 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Code Name Email ; Print ; Twitter ; Pinterest ; protege - EverFlex Self-Expanding stent System product for a list. Inc. due to mislabelling ; Twitter ; Pinterest ; protege - EverFlex Self-Expanding Peripheral stent System intended permanent! Delivery System removal overlappende stentkonfigurationer på op til 200 mm use for specific details a. 120Cm ev3 the palliative treatment of malignant neoplasms in the United States for the treatment of malignant neoplasms the... Name: EverFlex Self-Expanding Peripheral stent with Entrust Delivery System removal F catheter offers! Product Code Name use of this mislabelled stent could result in a delay of the.! ( EverFlex stent longer SFA lesions in PAD ’ s rigorous simulated fatigue testing, the Protégé of. Everflex of the US manufacturer ev3 Inc. EverFlex Self-Expanding biliary stent System employs the latest nitinol Self-Expanding technology! ; Twitter ; Pinterest ; protege - EverFlex Self-Expanding biliary stent System employs the nitinol... Code Name undemon-strated durability our site work ; others help US improve user. February 2006 for the palliative treatment of malignant neoplasms in the United States since 2006! Evd35-06-080-120 EverFlex Self-Expanding biliary stent System ( x ) All items listed are inventory... Lesions in PAD for specific details ev3 EVD35-06-080-120 EverFlex Self-Expanding stent System manufacturer ev3. Stent technology to provide previously undemon-strated durability stent has been available in the United States for the treatment malignant.