† Rocha-Singh K et al. , due to labeling applied prior to the change in terminology, 2005) or “MR Conditional”, the timing of performing MRI following stent placement, and regarding what MRI limitations may exist (e. 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. Baseline Angiographic Results Details of the angiographic procedure and deployment of the Lesion location (%) SPIDER Embolic Protection System and the Protégé GPS Common carotid artery 5.6 Self-Expanding Nitinol Stent (ev3 Inc., Plymouth Minnesota) Internal carotid artery 75.2 Both 19.1 have been described previously (2). 14 Stores, One Shopping Cart. Skip to main content Skip to main content. 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. TrelliX Embolic Coil System, All Versions. Non-clinical testing and MRI simulations were performed to evaluate the entire family (i. A self-expandable Protégé GPS stent (12 mm × 60 mm) (ev3) with 12 radioactive 125 I seed strand was implanted. Catheter Cardiovasc Interv. The SAMBA stent demonstrated an excellent safety profile. eSutures sells discounted, brand name sutures, suture material and endomechanicals. D) MRI showed cerebral infarctions in the left hemisphere. https://www.keyword-suggest-tool.com . Protege GPS Self-Expanding Stent Covidien and ev3 Inc., www.ev3.net 14 Stores, One Shopping Cart. The Protégé carotid stent system, with the embolic protection device, was studied in the prospective, nonrandomized, multicenter Carotid Revascularization With ev3 Inc. Arterial Technology Evolution (CREATE) trial of 419 patients with carotid artery disease who were at risk for stoke and at high risk for adverse events from surgery. 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. 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. Previous studies suggest that patients with carotid stenosis and serious comorbid cardiopulmonary and anatomic conditions are at high risk for carotid endarterectomy. * Compared with SFA studies of Cook Zilver PTX, IDEV SUPERA, Cordis Smart Stent, Bard Lifestent and EV3 Protégé Everflex. Introduction In our institute, most cases of carotid artery stenosis are treated by carotid artery stenting (CAS) with an open-cell stent and double-balloon protection, even if plaques are unstable. Ev3 protege stent mri safety keyword after analyzing the system lists the list of keywords related and the list of websites with related content, ... (Protégé GPS stent) is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6 F 0.035” over-the-wire (OTW) delivery system. Concern regarding the safety of Carotid angioplasty and stenting ... Cordis Smart (76,15.9%), Johnson & JohnsonCordis Precise (72,15.1%) and EV3 Protégé GPS (50,10.5%). SPIDER Embolic Protection System and the Protégé GPS Self-Expanding Nitinol Stent (ev3 Inc., Plymouth Minnesota) have been described previously (2). February 21, 2008 --- "Commercial Approval" field - Added CE Mark for general use … Protégé GPS consists of two parts — the stent and the delivery system. Product availability and / or specifications subject to change. Medtronic.com The Protégé GPS Self-Expanding Peripheral Stent Systems 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 reference vessel diameters of 7.5 – 11 mm. continued follow-up in clinical trials that capture the device’s safety and efficacy in the iliac, superficial femoral and proximal popliteal arteries. 8 SC820LG — SC840LG SC860LG SC880LG SC8100LG SC8120LG SC8150LG 6 130 9 SC920LG — SC940LG SC960LG SC980LG — — — 6 130 10 SC1020LG — SC1040LG SC1060LG SC1080LG — — — 6 130OPTIMISED CELL DESIGN FOR Stent Stent Length (mm) Minimum Catheter Working Diameter 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. Background: The purpose of the European PROCAR Trial was to evaluate the safety and performance of the Protégé stent in the treatment of common and/or internal carotid artery stenoses with adjunctive use of a filter embolic protection device. EverFlex™ Self-Expanding Peripheral Stent System"; ev3 Inc., February 21, 2008. ... An arteriogram after postdilation of the stent. Acculink Stent Mri Safety This stent platform seems to be safe and effective in the peri-procedural period. The Protégé GPS Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree. 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. Protégé GPS Self-Expanding Peripheral and Biliary Stent System The Protégé GPS self-expanding peripheral and biliary stent system, which has received FDA and CE Mark approv-als, allows physicians to treat iliac artery lesions and restore blood flow with large-diameter stents through a low-profile, 6 … Extrapolating from a previous study, where similar torsion testing was performed, the SAMBA stent outperformed the ev3 Protégé GPS™, which fractured at approximately 300,000 cycles, or the equivalent of 4 months . In ev3’s rigorous simulated fatigue testing, the Protégé EverFlex survived significantly longer than any competitive stent tested. 2007;69:910-919. Customer Service PH 800.716.6700 Fax 764.498.7001 www.ev3.net Instead, the operator may select The safety and effectiveness of this device for … January 27, 2007-- The Protégé® RX from eV3, Inc. was approved this week by the U.S. Food and Drug Administration, making it the fifth carotid stent available for marketing in the U.S.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. Shape Memory Medical, Inc., www.shapemem.com. MRI Safety Information. Title: ProtegeRXCarotidIFU#500766New.qkd Author: Stacy Moening Created Date: 5/17/2013 6:02:31 PM Unlike other distal protec-tion devices, the Capture Wire in the SPIDER system is not used to cross the target lesion. The Protégé GPS self-expanding stent is already approved for use in the superficial femoral and subclavian arteries. The distal segment of the 2nd stent was placed in the right anterior branch of the portal vein, whereas the proximal segment of the stent was situated within the previously placed stent, thereby forming a Y-configuration. Visit all our stores. All patients underwent percutaneous revascularization using the Protégé GPS self‐expanding nitinol stent (ev3, Plymouth, MN) and the Spider distal embolic protection system (ev3). This study was performed to examine the outcome of CAS with an open-cell stent and double-balloon protection for unstable plaques. WARNING: The safety and effectiveness of this device for use in the vascular system have not been established. The stent is intended to open arteries that have been narrowed as a result of plaque formation. Learn vocabulary, terms and more with flashcards, games and other study tools. The Protégé GPS self-expanding peripheral stent system allows physicians to treat iliac artery lesions and restore blood flow with large diameter stents through a low, 6F profile delivery system. The Protégé EverFlex Self-Expanding Stent System employs the latest nitinol self-expanding stent technology to provide previously undemon-strated durability. Medtronic Ev3 Protege Gps Self-Expanding Biliary Stent System 10 X 60. Express LD Iliac/Biliary Premounted Stent System 316L stainless steel: 0.035: 6 (up to 8 X 37 mm), 7 (up to 10 X 57 mm) 6–10 (5 mm, biliary indication only) 17, 25, 27, 37, 57: 75, 135: Iliac, biliary The. EV3 Protege GPS Nitinol Biliary Stent System - Independent Reviews by Clinicians for Clinicians. ev3 Corporate World Headquarters Peripheral Vascular 3033 Campus Drive Plymouth, ... Protégé GPS Self-Expanding Biliary Stent System is intended for the palliative treatment of malignant neoplasms in the biliary tree.