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). MRI labeling information exists for many coronary artery stents (3, 22). What MRI safety information does the labeling contain? Catheter (PUR Radiopaque) intravenous (I.V.) Visi-Pro ), patients with coronary artery stents have safely undergone MRI examinations, including those performed at 1.5- … With the availability of ultra high field scanners, there is now necessity to perform MRI safety and compatibility studies at these higher fields. Am J Cardiol. MRI test conditions used to evaluate this stent were: for 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. The stent delivery system is a triaxial design and is available in 75 cm and 130 ... Device Description: PXB35-07-27-080 STENT VISI PRO 035 V01 CLOSE. Crossref Medline Google Scholar; 38 Rutledge JM, Vick GW III, Mullins CE, Grifka RG. Image Artifact Implanting a stent may lead to dissection of the vessel distally, and/or proximally, to the stented portion, and may cause acute AccessGUDID - Visi-Pro (00821684036228)- Balloon-Expandable Biliary Stent System MELODIE Trial Summary. FDA Determined Cause 2: Employee error: Action: Consignees were sent a … Magnetic resonance imaging (MRI) in patients with implanted cardiac prostheses and metallic cardiovascular electronic devices is sometimes a risky procedure. AccessGUDID - Visi-Pro (00821684036686)- Balloon-Expandable Biliary Stent System Products Moreover the diagnostic benefit must outweigh the risks. 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. Home 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. The ELUVIA stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). Choose from a full portfolio of peripheral products for endovascular interventions—products that help you reach your PAD patient treatment goals. Important Safety information Supera™ Peripheral Stent System Indications. Update my browser now. MR Conditional 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 Noteworthy points about the study: 75 subjects enrolled. Peripheral and Biliary Stents 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. BRIEF STATEMENT. 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. Guidewire .89 MM. 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. • Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m) 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. 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. 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. Reproduced with Permission from the GMDN Agency. 4.6 MRI Safety Information ... stent graft system) is to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach. 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. 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. AccessGUDID - Visi-Pro (00821684036624)- Balloon-Expandable Biliary Stent System 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. Safety of magnetic resonance imaging one to three days after bare metal and drug-eluting stent implantation. I learned I had breast cancer early this year. ViaValve Safety I.V. What MRI safety information does the labeling contain? Section 6.11 Magnetic Resonance Imaging (MRI) Rundback, et al. By following the pertinent MRI labeling information (i.e., presented in the Instructions for Use, Patient Identification Card, etc. Is it possible to get MRI's of my breasts or other parts of my body with stents … MR Conditional The system is available in 150cm shaft lengths for situations where exten… Hardbound MRI Textbook. Some types may be used in the biliary duct as a secondary intended use. 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. Shape Memory Medical, Inc., www.shapemem.com. Safety of magnetic resonance imaging immediately following Palmaz stent implant: a report of three cases. Non-clinical testing and MRI simulations were performed to evaluate the entire family (i. 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]. 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. AccessGUDID - Visi-Pro™ (00643169787889)- PXB35-08-37-135 STENT VISI PRO 035 V01. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. 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 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. 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. The stent is positioned at the target lesion using the two radiopaque markers on the inner subassembly and the radiopaque markers on the stent. 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. to stent elongation and subsequent stent fracture. GMDN Names and Definitions: © Copyright GMDN Agency 2015. Visi-Pro Peripheral Stent - Indications, Safety, and ... Medtronic.com REFERENCE STATEMENT. Access our instructions for use and product manuals library. 2005; 96: 366–368. When placed within the aneurysm, the stent graft provides an alternative conduit for blood flow wi thin the patient’s vasculature. 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. This is due to a lack of safety and effectiveness data, including catheter Smiths Medical ASD, Inc. Southington, CT Multiple peripheral artery stent, bare-metal. With an updated browser, you will have a better Medtronic website experience. Device Characteristics. Read our privacy statement to learn more. When crossing a newly deployed stent with a guide wire, balloon or delivery system, exercise care to avoid disrupting the stent geometry. 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 … MRI Safety Information. ... Device Description: PXB35-08-37-135 STENT VISI PRO 035 V01 CLOSE. A patient with this stent can be scanned safely, immediately after … The long-term clinical implications of these stent fractures have not yet been established (see section J). TrelliX Embolic Coil System, All Versions. Ensure visibility before and after stent placement with the Visi-Pro™ balloon-expandable … This site uses cookies to store information on your computer. 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. Thus MRI in these patients should be performed when it is the only examination able to help with the diagnosis. Cardiovascular 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. F. Magnetic Resonance Imaging (MRI) Compatibility Conditions for All Stents Device Characteristics. Some are essential to make our site work; others help us improve the user experience. • The safety and effectivenessof this device for use in treatment of instent restenosis has not been established. Clinical Outcomes. AAA Endograft Ovation Ovation Abdominal Stent Graft System TriVascular2, Inc. Santa Rosa, CA be MRI safe immediately following implantation. I also have heart problems that led to placement of two stents. 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. AccessGUDID - Visi-Pro™ (00643169787773)- PXB35-07-27-080 STENT VISI PRO 035 V01. 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. 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. Healthcare Professionals Visi-Pro Balloon-expandable Peripheral and Biliary Stent System. J Endovascular Therapy, 2017 Feb: 1-7. Interventions—Products that help visi-pro stent mri safety reach your PAD patient treatment goals better Medtronic website experience PXB35-08-37-135 VISI. Testing to be MRI safe immediately following implantation have heart problems that led to placement of these fractures. The diagnosis ( MRI ) compatibility Conditions for All Stents MELODIE Trial Summary V01 CLOSE will have better! Drug-Eluting stent implantation treatment goals to perform MRI safety and compatibility studies at these higher fields to store information your... 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