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EV3 Inc. EverFlex Self-Expanding Biliary Stent Systems Recalled by the FDA The notice from the FDA can be read here. 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. ev3 also obtained CE Mark for the EverFlex for general use in the peripheral vasculature, including the iliac, subclavian and superficial femoral artery. 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.
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The EverFlex™ Self-Expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. EverFlex™ Self-Expanding Peripheral Stent System"; ev3 Inc., February 21, 2008. EverFlex™ Self-Expanding Peripheral Stent System"; ev3 Inc., February 21, 2008. 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. 0000007075 00000 n
The EverFlex stent has been available in the United States since February 2006 for the palliative treatment of malignant neoplasms in the biliary tree. A prescription is required. The EverFlex Self-Expanding Stent System is indicated in the United States for the palliative treatment of malignant neoplasms in the biliary tree. Gældende for en samlet stentlængder på op til 200 mm. STENT, SUPERFICIAL FEMORAL ARTERY (6) …
Multiple peripheral artery stent, bare-metal (6) FDA Product Code Name. Address: 3033 Campus Drive, Suite #N550, Plymouth, MN 55441 Approval Date: October 10, 2014 0000003037 00000 n
Bemærk.
BRIEF STATEMENT. 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 … 0000032684 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.
The EverFlex™ self-expanding peripheral stent system (EverFlex stent) is a self-expanding Nitinol stent system intended for permanent implantation. EverFlex™ Protégé™ EverFlex™ (6) GMDN Term. 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. 0000011131 00000 n
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. The EverFlex Self-Expanding Stent System is indicated in the United States for the palliative treatment of malignant neoplasms in the biliary tree.
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Indications, Safety, and Warnings.
Design of EverFlex Self-expanding Peripheral Stent with Entrust Delivery System. Ev3 is conducting a voluntary recall on three lots of the prot¿g¿ everflex" biliary stent system. AccessGUDID - EverFlex™ Protégé™ EverFlex™ (00821684059852)- STENT PRB35-06-030-080 PROTEGE EF V07 Electromagnetic Compatibility Guide for Cardiac Devices, Minimally Invasive Therapies (formerly Covidien), Information About Proposition 65 for California Customers, California Transparency in Supply Chains Act. 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. Clinical Relevance. Protege EverFlex Self-Expanding Stent Covidien and ev3 Inc., www.ev3.net 0000012053 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. Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions.
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 … PROTÉGÉ™ EverFlex™ is a superb next generation stent with an outstanding combination of strength, flexibility and durability.
Please consult your physician.
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Read our privacy statement to learn more. ev3 has already begun commercial release throughout Europe. Design of EverFlex Self-expanding Peripheral Stent with Entrust Delivery System. 0000001734 00000 n
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