and MIAMI, Jan. 16, 2012 / PRNewswire / -- Boston Scientific Corporation (NYSE: BSX) reports nine-month clinical endpoint data from its ORION trial, demonstrating excellent outcomes for the Company's Epic Self-Expanding Nitinol Stent . Cook Medical. Model #: 38047-86013 Express LD Iliac/Biliary OTW Premounted Stent System - 8mm x 57mm x 135cm. From Which Medical Device. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION . Version (Model) Number: H74938047120130. 17, 25, 27, 37, 57: 75, 135: Iliac, biliary: Boston Scientific Corporation: Express SD Renal Monorail Premounted Stent System 316L stainless steel: 0.018: 5 (up to 6 X 18 mm), 6 (up to 7 X 19 mm) . Company's fully covered metal stent now approved for use in treating benign biliary strictures Boston Scientific Corporation (NYSE: BSX) today announced that its WallFlex Biliary RX Fully Covered Stent has received CE Mark approval for the treatment. n Express LD iliac stent The Express LD stent was approved in March 2010 for the treatment of atherosclerotic lesions found in iliac arteries up to 100 mm in length, with a reference diameter of 6-10 mm (Figure 1). manufacturer of a wide range of products which include boston scientific acquire endoscopic ultrasound fine needle biopsy (fnb) device, boston scientific stretch vl flexima ureteral stent set, boston scientific sentai guidewires, boston scientific cre single-use pulmonary balloon dilatation catheter, boston scientific zipwire nitinol hydrophilic Address: 3M China Co., Ltd Shanghai, China, 8 Xingyi Road, Wan Building, 38th Floor, Postal Code: 200336 Tel: 86-2162753535 345 E. Main St. * Development of. This device is the biliary version of Boston Scientific's Wallstent. It is available in a range of sizes from 16 mm to 34 mm and lengths from 30 mm to 100 mm. 0.3. CONTRAINDICATIONS Generally, contraindications for Percutaneous Transluminal Angioplasty (PTA) are also contraindications for stent placement. Express LD Iliac / Biliary H74938046830750 GUDID 08714729579670 Premounted Stent System BOSTON SCIENTIFIC CORPORATION. This device is designed and intended for one time use only. Boston Scientific Announces FDA Clearance and CE Mark Approval for Advanix Biliary Stents Devices Interventional FDA. We use this stent both in the vascular and biliary tree. when a man criticizes another woman; wonderboom 2 turn off startup sound Skip to Main Content; . Boston Scientific Corporation: Express LD Iliac/Biliary Premounted Stent System 316L stainless steel . Boston Scientific Corporation Customer Service: 8882721001 www.bostonscientific.com Page 1 of 12 PI86716AG Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Products Table of Contents 1. This self-expanding Nitinol Stent System is a 10F application device which is adapted to .035 inch guide wire. A braided outer sheath provides high kink resistance and flexibility for steering. Rosen Wire Guide. Bard LUMINEXX 3 Biliary and Vascular Stent Nitinol, tantalum 14-mm x 120-mm C. R. Bard Angiomed GmbH & Co. Medizintechnik KG Karlsruhe, Germany What MRI safety information does the labeling contain? Under the scan conditions defined above, the Express LD Stent is expected to produce a maximum temperature rise of less than 4C Express LD iliac and Biliary Added Jun 14, 2018 Manufactured by Boston Scientific This open cell balloon mounted stent from Boston is claimed to have excellent radial force. 409488810; Hospira; Diluent Sodium Chloride, Preservative Free 0.9% Solution Single Dose Vial 10 mL; 25 per box . Skip to Main Content; . Additionally, we fully launched the express LD iliac stent . Bard PV describe the device as a uniquely flexible stent with a competitive radial strength with minimal recoil. A prescription is required. Manufacturer: . rated Burst pressure atm . Oct 21, 2010 Decades of partnership with clinicians around the globe has resulted in unparalleled performance across multiple indications. MR Conditional . unregistered register now: see also: IMPLANTS: USA: product group: general tissue: . Add to Cart The item has been added. W. L. Gore & Associates has insufficient clinical and experimental data regarding the use of the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface within stents or stent grafts (other than the GORE VIABAHN SUPERA Veritas Self-Expanding Nitinol Stent. This product line is serviced by the following clinical division (s): Aortic Intervention . Description. Coils, Filters, Stents, and Grafts More. Safe More. The Express LD Iliac Premounted Stent System is indicated for the treatment of atherosclerotic lesions found in iliac arteries up to 100 mm in length, with a reference diameter of 6 mm to 10 mm. Boston Scientific Corporation: Express LD Iliac/Biliary Premounted Stent System 316 L stainless steel: 0.035 (0.89 mm) 6 (2 mm): up to 8 X 37 mm; 7 (2.51 mm): up to 10 X 57 mm . HSMN NewsFeed - 8 Apr 2016 . for permanent implantation. Phone: 574-2676131 Warsaw, IN 46580 United States Toll Free: 800-6136131 The stent is cut from a Nitinol tube in an open lattice design and has tantalum radiopaque markers at the proximal Radiopaque markers on the stent ensure precise placement. Global Unique Device ID: 08714729392378. Coils, Filters, Stents, and Grafts More. Model #: G52917 Gunther Tulip Vena Cava Filter Set - IGTCSF-65-1-FEM-TULIP - 7Fr x 65cm . . MRI Safety Status: MR Conditional: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: What MRI safety information does the labeling contain? Radiopaque markers on the inner sheath assist stent placement. Data from Medicare Claims Analysis wireguide safety j rosen cath exchange 35 x 260 x 1.5 wireguide safety j rosen cath. Out of stock. AccessGUDID - Express LD Iliac / Biliary (08714729579656)- Premounted Stent System. IMPLANON etonogestrel implant contraceptive implant flexible plastic rod Organon USA Inc. Roseland, NJ Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions. boston scientific corp 37911-51515 stent biliary sd express 5mmx15mmx150cm premount 37911-51515 . The Absolute Pro LL Peripheral Self-Expanding Stent is a standard over the wire nitinol stent. Outcome Mean percent luminal diameter loss at 6 months = 16.2% 18.4% Upper Confidence Int = 19.6% Clinical follow-up rate at 6 months = 92.6% (138/150) This rate was non-inferior to the Objective Performance Criterion = of 20% NATICK, Mass. Only Express SD has the ideal balance of strength and precision for acute success. 1.5,3: Conditional 5 More. MR Conditional . Stents were imaged at 1.5 T and . Company Name: BOSTON SCIENTIFIC CORPORATION. stent biliary ld express 6mmx30mmx75cm premount 38046-63075 38046-72075 . It requires a 6F sheath 2FUP MLD = Follow-up minimum lumen diameter at 6 months. Burg (39) evaluated the in vitro lumen visibility of 22 different peripheral arterial stents (iliac, renal, and carotid) via magnetic resonance angiography (MRA). Qty Avail: 0. 3: Conditional 7 More. Skip to Main Content; . Boston Scientific Corporation: IceRod 1.5 MRI 90 Cryoablation Needle Their website compares it with 5 other selected stents. Drummond wire (316L SS) orthopedic implant. $549.00 /Each. The Xpert system comprises a 4F compatible nitinol stent, for recommended use with a 0.018" guidewire system. BOSTON SCIENTIFIC; BOSTON SCIENTIFIC. The device has been commercially available as a biliary stent in the USA since October 2002, and as a peripheral vascular stent . EV3 . It is available in 6-10mm diameters and lengths from 17-57mm. 6 Express V ascular LD Boston. Express LD Iliac Premounted Stent System Warning The Express LD Iliac Stent may cause image artifacts with MRI scans due to distortion of the magnetic field. De La Cruz Fluoroplastic, Platinum, Piston Otologic Implant Medtronic Xomed, Jacksonville, T . Boston Scientific Express LD Iliac; Biliary OTW Stent; 6mm x 37mm, 75cm Rating Required Select Rating 1 star (worst) 2 stars 3 stars (average) 4 stars 5 stars (best) 1Post MLD = Post-procedure minimum lumen diameter. Newmatic Medical, www.newmaticmedical.com. The Express LD Stent should not migrate in this MRI environment. The VIABAHN Device is a leader among stent grafts. To get physicians impacted for your Hospital, click here. $20.00. Iliac artery stent, bare-metal A non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery(ies) to maintain arterial . 2 Boston Scientic (aster Brand DFU Template 8.2677in x 11.6929in A4, 90105918A), eDFU, B, Express LD Iliac/Biliary, EN, 90991889-01A table 1. express Ld iLiaC premounted stent system specifications product Code Crimped stent Length (mm) Balloon size Catheter usable Length (cm) stent nominal pressure atm (kpa) Max. Dry Pad 9 x 9 with Silver Antimicrobial Agent. Mar 10, 2010 What MRI safety information does the labeling contain? FDA Approves Boston Scientific's Express(R) LD Iliac . . Brand Name: Express LD Iliac / Biliary. The Xpert Self-Expanding Stent System from Abbott Vascular is designed for use in peripheral vessel procedures. 38046-74075; Boston Scientific; Express LD Iliac; Biliary OTW Stent; 7mm x 37mm, 75cm N95 masks, regular earloop masks, disinfecting wipes, hand sanitizer, thermometers, isolation gowns, gloves and other infection control are AVAILABLE IN 3 WEEKS OR LATER AFTER THE ORDER. MAGNETIC RESONANCE IMAGING (MRI) INFORMATION : Nonclinical testing has demonstrated the Express LD Stent in single and overlapped conditions is MR Conditional. Express LD Iliac/Biliary OTW Premounted Stent System - 10mm x 57mm x 135cm - Non-Expired. : A biliary stent that expands automatically after being released from a stent delivery system (e.g., a catheter); i.e., it does not require balloon inflation or other 3 1. exchange 35 x 260 x 1.5 femoral, iliac arteries or the venous anastomosis of the arteriovenous (AV) access circuit. Primary or selective stent implantation is a common revascularization strategy for patients with aortoiliac occlusive disease 1, 2, 3, 4.Uncertainty remains regarding optimal stent selection during iliac artery intervention, as comparative studies are limited 1, 5, 6, 7.Both balloon-expandable and self-expanding stents have demonstrated high procedural success rates and satisfactory midterm . (CWS; Boston Scientific, Natick, MA, USA), which is made of cobalt-chromium alloy and tantalum, generates severe artifacts as compared with nitinol stents . Miscellaneous Implants and Devices More . Manufacturer: EV3. Paclitaxel . Manufacturer: Boston Scientific. This therapy is not for everyone. AccessGUDID - Express LD Iliac / Biliary (08714729392330)- Premounted Stent System. Protege GPS Nitinol Biliary Stent System. The Valeo Biliary Stent is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree. MR Conditional . Iliac artery stent, bare-metal A non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery(ies) to maintain arterial . Mar 10, 2010 Indications, Safety, and Warnings Product Details Back to top It is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6F over-the-wire delivery system. THE CARDIOMEMS HF SYSTEM RECEIVES FDA APPROVAL TO SUPPORT PATIENTS BATTLING EARLIER-STAGE HEART FAILURE. UPC: Current Stock: This item is out of stock. . Free essays, homework help, flashcards, research papers, book reports, term papers, history, science, politics FDA Approves Boston Scientific's Express LD Iliac Stent System First and only premounted, balloon-expandable stent approved specifically for use in iliac arteries Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved its Express LD Iliac. The stent faces a review Thursday by the panel, which will make recommendations on whether the FDA should approve the device. It has a delivery handle incorporating a wheel that is turned to uncover the stent. $40.00. Interventional Cardiology Vascular Surgery Interventional Radiology For more information, please call Medtronic at 1-763-514-4000 (Worldwide). FDA Approves Boston Scientific's Express LD Iliac Stent System First and only premounted, balloon-expandable stent approved specifically for use in iliac arteries Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved its Express LD Iliac. Boston Scientific Corporation: Express LD Iliac/Biliary Premounted Stent System . Boston Scientific Announces CE Mark For MRI Labeling Of Emblem(TM) S-ICD Systems Devices Cardiology Regulatory. Bentson, Flexible Tip 6 items; Beveled Needle. Boston Scientific. The manufacturer describes the device as a self-expanding Nitinol stent system designed for the palliative treatment of malignant neoplasms in the biliary tree. Boston Scientific 28 years 9 months Senior R&D Manager Oct 2008 - Present13 years 9 months Arden Hills, MN * R&D management - 18 engineers, technicians and lab supervisor. What MRI safety information does the labeling contain? 1-5; of; 7; Sort By: Express LD iliac and Biliary. Orthopedic Implants, Materials, and Devices More. Nine-month data presented at ISET support safety and efficacy of Epic Stent in iliac stenting. The Protg GPS self-expanding stent (Protg 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. Non-clinical testing at field strengths other than 1.5 Tesla or 3 Tesla has not been performed to evaluate stent migration or heating. Skip to Main Content; . Specifications Images. S-11G Ampco Safety Tools Garland, TX. 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: Boston Scientific Corporation: . self-expanding wallstents (boston scientific, marlborough, ma) were first deployed in the sfa in the late 1990s but were quickly shown to be inferior to nitinol self-expanding stents with a relatively high rate of strut fracture. It is available in 6-10mm diameter and 10-100mm length. The VIABAHN Device features: Lengths up to 25 cm Low profile design Multiple FDA approved indications for use Radiopaque markers Proven CBAS Heparin Surface technology Guidant Corporation, part of Boston Scientific and Abbott Labs, address of Boston Scientific. AccessGUDID - Express LD Iliac / Biliary (08714729392293)- Premounted Stent System. The stent's patented design balances strength and flexibility for proven patency as found in the VISIBILITY ILIAC study. x 57 mm Length . Express SD Renal and Biliary Premounted Stent System The Express SD Stent couples excellent compression resistance with lower stent foreshortening and recoil.
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