Carotid artery stenting was performed with the Protégé Self-Expanding Nitinol Stent and the SPIDER Embolic Protection System (ev3 Inc., Plymouth, Minnesota). In Stock! Results of the Protégé EverFlex 200-mm-long nitinol stent (ev3) in TASC C and D femoropopliteal lesions Marc Bosiers, MD,a Koen Deloose, MD,a Joren Callaert, MD,a Nathalie Moreels, MD,a Koen Keirse, MD,b Jürgen Verbist, MD,b and Patrick Peeters MD,b Dendermonde and Bonheiden, Belgium Objectives: This study investigated the results with primary stenting using the Protégé … Results of the Protégé EverFlex 200-mm-long nitinol stent (ev3) in TASC C and D femoropopliteal lesions Marc Bosiers, MD, aKoen Deloose, MD, Joren Callaert, MD,a Nathalie Moreels, MD, Koen Keirse, MD, bJürgen Verbist, MD, and Patrick Peeters MD,b Dendermonde and Bonheiden, Belgium Objectives: This study investigated the results with primary stenting using the Protégé EverFlex … Aspirin and clopidogrel were prescribed at least 24 h before and three months after revascularization. EPDs (Random Selection) FilterWire (Boston Scientific) ... stent Accu-link Precise Protégé Expo-nent (%) 1.2 1.0 3.3 1: Add SERB65-10-60-80 EV3 PROTEGE GPS Self-Expanding-Biliary-Stent System -10mm x 60mm x 80cm: 10mm x 60mm x 80cm $175.00. Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial (CREATE) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Angiogram image of the ev3 Protégé Rx stent K. Mathias, MD, department of radiology, Klinikum Dortmund, Germany CREATE was a prospective, nonrandomized study at 31 centers in the United States. Recall Protégé EverFlex, ev3. EV3 PROTEGE RX Carotid Stent System - 7mm x 40mm x 135cm: 7mm x 40mm x 135cm $200.00. The Protégé is a self-expanding Nitinol stent which is part of a carotid stent system when paired with eV3's SpideRX® Embolic Protection Device. ev3 also obtained CE Mark for the EverFlex for general use in the peripheral vasculature, including the iliac, subclavian and superficial femoral artery. eSutures sells discounted, brand name sutures, suture material and endomechanicals. A total of 77 patients have been enrolled in the trial. Protégé GPS consists of two parts — the stent and the delivery system. Ships Today! "The stent design and fatigue data generated to date suggest that ev3 has made significant strides in addressing the clinical challenge of stent fracture." The primary outcome was the combined incidence Carotid artery stenting was performed with the Protégé Self-Expanding Nitinol Stent and the SPIDER Embolic Protection System (ev3 Inc., Plymouth, Minnesota). stents/protg-everflex-selfexpanding-peripheral-stent-system.htm > "Protege™ EverFlex™ Self-Expanding Peripheral Stent System"; ev3 Inc.; September 7, 2010. Clinical Relevance. $999.00 box of 1 - ev3 # PRB35-05-020-120 - ev3 Protege EverFlex Self-Expanding Biliary Stent System: 5mm x 20mm x 120cm Title: ProtegeRXCarotidIFU#500766New.qkd Author: Stacy Moening Created Date: 5/17/2013 6:02:31 PM Ev3 inc. is conducting a voluntary recall of specific lots of the protege gps self-expanding stent system because labeling did not match the actual stent size contained in the package. the affected product was labeled as a 6mm x 80mm protege gps stent but actually contained an 8mm x 40mm stent. The Durability-200 study is the first trial investigating the results with primary stenting using Protégé EverFlex 200-mm-long self-expanding nitinol stents (ev3 Endovascular Inc, Plymouth, Minn) in femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C and D lesions at least 150 mm in length. 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. The PROTÉGÉ® RX Carotid Stent System, when used in conjunction with the ev3 Inc. embolic protection systems, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and … PLYMOUTH, Minn., Jan. 24-- ev3 Inc. (Nasdaq: EVVV - News) today announced U.S. Food and Drug Administration approval of the PROTEGE® RX Carotid Stent.This stent, when used in conjunction with the ev3 embolic protection device, is indicated for the treatment of carotid artery disease in patients who are at high-risk for adverse events from carotid artery surgery. Listing a study does not mean it has been evaluated by … Recall of a specific lot of the self-expanding peripheral stent Protégé EverFlex of the US manufacturer ev3 Inc. due to mislabelling. We are a liquidator of sutures (and other surgical items) from Ethicon, Covidien AutoSuture, Synthes, Stryker, Arthrex and are able to pass our savings on to you. 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. Zilver Flex ™ Stent P<0.0001 ev3 Protégé ® EverFlex Stent P<0.0001 Cook Zilver ® Stent P<0.0001 Abbott Absolute ® Stent P<0.0001 Higher value = greater radial strength Statistically significant di rence if P<0.05 1.42 Reference: 1. Study patient assessments were conducted at baseline, periprocedure, discharge, and 1 and 6 months postprocedure. Co announced U.S. Food and Drug Administration approval of the Protege RX Carotid Stent. Self-Expanding Peripheral Stent System INSTRUCTIONS FOR USE DEVICE DESCRIPTION The EverFlex™ Self-Expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. Indications: The Protégé™ RX carotid stent system, when used in conjunction with the ev3 embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and … AIM: The present trial studied efficacy of long ev3 Protégé Everflex stents used in the treatment of long and complex occlusive lesions of the -superficial femoral artery (SFA) and the popliteal artery. 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). All patients underwent percutaneous revascularization using the Protégé GPS self-expanding nitinol stent (ev3, Plymouth, MN) and the Spider distal embolic protection system (ev3). The stent is intended to open arteries that have been narrowed as a result of plaque formation. EV3 Protege® RX Carotid System - SECX-9-40-135 Stent SE de Vende - DOTmed Lista #2128392: 6FrUsable Shaft Length: 162cmStent Size Diameter: 9mmStent Lenght: 135mmLumen Diameter: 7.5-8.5mmSterileSingle Use Only1 Piece In-hospital and 30-day outcomes were analyzed. ObjectivesThis 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.MethodsBetween March 2008 and June 2009, 100 patients (66 men) presenting … The EverFlex stent has been available in the United States since February 2006 for the palliative treatment of malignant neoplasms in the biliary tree. METHOD: The Protégé GPS stent is a self-expanding Nitinol stent system mounted on a 6 Fr 0.018'' (6-9 mm stent) or 7 Fr 0.035'' (10 mm stent) over-the-wire delivery system. The FDA has approved ev3’s Protégé GPS Self-Expanding peripheral stent system for use in the iliac arteries, which supply blood to the pelvis and legs. The stent is used in conjunction with the ev3 embolic protection device, SpideRX Embolic Protection Device (EPD) was previously FDA cleared for carotid use in February 2006. Aspirin and clopidogrel were prescribed at least 24 h before and three months after revascularization. Protege RX SE Carotid Stent - Indications, Safety, and ... Medtronic.com BRIEF STATEMENT. 1: Add SECX-8-6-40-135 EV3 PROTEGE RX Carotid Stent System - 8 - 6mm x 40mm x 135mm: 8-6mm x 40mm x 135mm $200.00. EV3 PROTEGE RX Carotid Stent System - 7mm x 20mm x 135cm: 7mm x 20mm x 135cm $200.00. The stent is cut from a Nitinol tube into an open lattice design and has tantalum radiopaque markers at the proximal and distal ends of the stent. The stent, a nickel-titanium alloy tube laser cut into a mesh … Protégé (ev3) Xact (Abbott) Embolic Protection Systems zDistal balloon-occlusive systems zDistal filter systems zProximal balloon-occlusive (flow-blockage) systems. September 3, 2009 --- "Development Status - Clinical Trials" field - Added clinical trial data and link for DURABILITY I --- … 2004 and October 2004. The Durability-200 study is the first trial investigating the results with primary stenting using Protégé EverFlex 200-mm-long self-expanding nitinol stents (ev3 Endovascular Inc, Plymouth, Minn) in femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C and D lesions at least 150 mm in length. Data on file at Cordis. Abstract. The use of this mislabelled stent could result in a delay of the procedure. In addition to providing a balance of strength and flexibility, the PROTEGE EverFlex provides similar delivery and deployment to the current PROTEGE stent family. 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