Healthcare Professionals A sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. • Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m) Catheter (PUR Radiopaque) intravenous (I.V.) 4.6 MRI Safety Information ... stent graft system) is to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach. AccessGUDID - Visi-Pro™ (00643169787773)- PXB35-07-27-080 STENT VISI PRO 035 V01. 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. Hardbound MRI Textbook. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. MRI test conditions used to evaluate this stent were: for magnetic field interactions, a static magnetic field strength of 3 tesla with a maximum spatial gradient magnetic field of 3.3 tesla/meter; for MRI-related heating, a maximum whole body averaged specific absorption rate (SAR) of Read our privacy statement to learn more. Cardiovascular with stents are routinely imaged at 1.5T and 3T where the safety and MRI compatibility of some of these devices have been previously investigated [1]. MRI Safety Information. Designed to expand to every demand, the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) offers proven procedural success and long-term outcomes through flexibility, strength and accuracy to treat aortoiliac occlusive disease. Access our instructions for use and product manuals library. VISIBILITY ILIAC was conducted to confirm the safety and effectiveness of primary stenting using the Visi-Pro™ balloon-expandable peripheral stent system for the treatment of lesions in the common and external iliac arteries. This site uses cookies to store information on your computer. MRI test conditions used to evaluate this stent were: for Safety of magnetic resonance imaging immediately following Palmaz stent implant: a report of three cases. to stent elongation and subsequent stent fracture. Noteworthy points about the study: 75 subjects enrolled. Moreover the diagnostic benefit must outweigh the risks. The stent is positioned at the target lesion using the two radiopaque markers on the inner subassembly and the radiopaque markers on the stent. Visi-Pro Peripheral Stent - Indications, Safety, and ... Medtronic.com REFERENCE STATEMENT. When crossing a newly deployed stent with a guide wire, balloon or delivery system, exercise care to avoid disrupting the stent geometry. Ensure visibility before and after stent placement with the Visi-Pro™ balloon-expandable … Safety of magnetic resonance imaging one to three days after bare metal and drug-eluting stent implantation. Shape Memory Medical, Inc., www.shapemem.com. Reproduced with Permission from the GMDN Agency. I learned I had breast cancer early this year. 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 Some types may be used in the biliary duct as a secondary intended use. MELODIE Trial Summary. • The safety and effectivenessof this device for use in treatment of instent restenosis has not been established. What MRI safety information does the labeling contain? F. Magnetic Resonance Imaging (MRI) Compatibility Conditions for All Stents Visi-Pro Section 6.11 Magnetic Resonance Imaging (MRI) 2005; 96: 366–368. Am J Cardiol. With an updated browser, you will have a better Medtronic website experience. Important Safety information Supera™ Peripheral Stent System Indications. 5.4.1 MRI Statement The MULTI-LINK VISION Coronary Stent has been shown in non-clinical testing to be MRI safe immediately following implantation. Device Characteristics. BRIEF STATEMENT. catheter Smiths Medical ASD, Inc. Southington, CT Visi-Pro Balloon-expandable Peripheral and Biliary Stent System. Indications: The Visi-Pro™ balloon-expandable peripheral stent system is indicated for improving luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 10 mm. AccessGUDID - Visi-Pro (00821684036686)- Balloon-Expandable Biliary Stent System AccessGUDID - Visi-Pro (00821684036228)- Balloon-Expandable Biliary Stent System ... Device Description: PXB35-07-27-080 STENT VISI PRO 035 V01 CLOSE. The system is available in 150cm shaft lengths for situations where exten… ViaValve Safety I.V. Visi-Pro Balloon-expandable Peripheral and Biliary Stent System, Electromagnetic Compatibility Guide for Cardiac Devices, Visi-Pro Balloon-expandable Peripheral Stent System, Minimally Invasive Therapies (formerly Covidien), Information About Proposition 65 for California Customers, California Transparency in Supply Chains Act, Target vessel diameter is ≥ 5.0 cm and ≤ 10 cm. be MRI safe immediately following implantation. Stents, drains and dilators for the biliary ducts, Special Storage Condition, Specify: Keep dry, Special Storage Condition, Specify: Keep away from sunlight, Device Size Text, specify: Max. Home 2 Boston Scienti≥c, (Master Brand DFU Template 8.2677in x 11.6929in A4, 92238519A), eDFU, MB, VENOUS WALLSTENT, en 50607601-01B Black (K) ≤E fl5.0 • 8.2. GMDN Names and Definitions: © Copyright GMDN Agency 2015. Is it possible to get MRI's of my breasts or other parts of my body with stents … MELODIE is a prospective, multi-center, single arm study to obtain additional data on the safety and efficacy of the Express™ Vascular LD stent implantation in the treatment of stenosed or occlusive atherosclerotic disease (de novo or … The system's low profile (5Fr), triaxial design reduces friction during deployment, which allows for increased accuracy and more predictable stent placement. By using the site, you consent to the placement of these cookies. Guidewire .89 MM. By following the pertinent MRI labeling information (i.e., presented in the Instructions for Use, Patient Identification Card, etc. Crossref Medline Google Scholar; 38 Rutledge JM, Vick GW III, Mullins CE, Grifka RG. ... Device Description: PXB35-08-37-135 STENT VISI PRO 035 V01 CLOSE. MRI Safety PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System Below is an excerpt of Section 6.11 from the Directions for Use detailing the safety of performing MRI following the placement of a PROMUS Element Plus Stent. The Absolute Pro Vascular Self-Expanding Stent System is indicated for improving luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery with reference vessel diameters between 4.3 mm to 9.1 mm and lesion lengths up to 90 mm. AccessGUDID - Visi-Pro™ (00643169787889)- PXB35-08-37-135 STENT VISI PRO 035 V01. FDA Determined Cause 2: Employee error: Action: Consignees were sent a … Multiple peripheral artery stent, bare-metal. Products Image Artifact Implanting a stent may lead to dissection of the vessel distally, and/or proximally, to the stented portion, and may cause acute MRI labeling information exists for many coronary artery stents (3, 22). AccessGUDID - Visi-Pro (00821684036624)- Balloon-Expandable Biliary Stent System MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION Non‐clinical testing has demonstrated that WALLSTENT Tracheobronchial is MR Conditional for single and overlapping lengths up to 120 mm. Rundback, et al. The stent delivery system is a triaxial design and is available in 75 cm and 130 Magnetic resonance imaging (MRI) in patients with implanted cardiac prostheses and metallic cardiovascular electronic devices is sometimes a risky procedure. A patient with this stent can be scanned safely, immediately after … The ELUVIA stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). VISIBILITY ILIAC was conducted to confirm the safety and effectiveness of primary stenting using the Visi-Pro™ balloon-expandable peripheral stent system for the treatment of lesions in the common and external iliac arteries. You may at any time change the settings regarding cookies. The Express SD Renal Stent has been shown to be MR safe at field strength of 3 Tesla (T) or less, and a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR imaging. With the availability of ultra high field scanners, there is now necessity to perform MRI safety and compatibility studies at these higher fields. ), patients with coronary artery stents have safely undergone MRI examinations, including those performed at 1.5- … MR Conditional The long-term clinical implications of these stent fractures have not yet been established (see section J). Clinical Outcomes. This is due to a lack of safety and effectiveness data, including For Healthcare Professionals For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. Choose from a full portfolio of peripheral products for endovascular interventions—products that help you reach your PAD patient treatment goals. What MRI safety information does the labeling contain? A patient with an implant from this family can be scanned safely in an MR system under the following conditions: • Static magnetic field of 1.5-Tesla or 3-Tesla, only. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than forty internationally respected experts in the field. Thus MRI in these patients should be performed when it is the only examination able to help with the diagnosis. J Endovascular Therapy, 2017 Feb: 1-7. Non-clinical testing and MRI simulations were performed to evaluate the entire family (i. When placed within the aneurysm, the stent graft provides an alternative conduit for blood flow wi thin the patient’s vasculature. MR Conditional Update my browser now. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. The ELUVIA stent and catheter components are identical in material and design to the BSC Innova Self-Expanding Stent System (reference P140028, approved July 21, 2015). AAA Endograft Ovation Ovation Abdominal Stent Graft System TriVascular2, Inc. Santa Rosa, CA I also have heart problems that led to placement of two stents. TrelliX Embolic Coil System, All Versions. ev3, Inc. has determined that specific lots of the Visi-Pro" BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended. Some are essential to make our site work; others help us improve the user experience. Peripheral and Biliary Stents Noteworthy points about the study: Read more about the VISIBILITY ILIAC clinical study in a published, peer-reviewed journal: Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months. Deliver the same, trusted Protégé EverFlex stent with the ease of single handed deployment when choosing the EverFlex self-expanding peripheral stent with Entrust delivery system to treat PAD in the SFA, proximal popliteal, subclavian, and common or external iliac arteries. Device Characteristics. Contraindications: Use of the Visi-Pro balloon-expandable peripheral stent system is contraindicated in patients with known hypersensitivity to stainless steel or its components; patients contraindicated for anticoagulant and/or antiplatelet therapy; patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site; perforation at the angioplasty site; aneurysm of the artery to be treated. 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