Never use air or any gaseous medium to inflate the balloon. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. Dr. Gerard O'Sullivan, FSIR, FEBIR of Galway University Hospitals in Galway, Ireland and Dr. Steven Dubenec, MBBS, FRACS, Head of Vascular Surgery at the Royal Prince Alfred Hospital in Sydney, Australia discuss important features of the VenovoVenous Stent and their personal experiences using the product. 1.5, 3: Conditional 5 More. Broadest size matrix of iliofemoral-indicated venous stents in the U.S. Flared ends designed toreduce stent migrationand maximize wall apposition, Designed for use inhigh compressioniliofemoral venous obstructions, Open-cell,flexible designto conform to vessel curvature while maintaining lumen diameter, Highest mean radial resistive forceamong tested iliofemoral venous stents, Tantalum markers forenhanced visibilityunder fluoroscopy, Minimal foreshortening for maximum lesion coverage, Operator control with an ergonomic handle and dual-speed thumbwheels, Primary safety: Freedom from Major Adverse Events (MAE), including stent migrations, at 30 days, Primary Effectiveness: Primary Patency at 12 months, Venous Clinical Severity Score (VCSS) through 36 months. Do not exceed the balloon rated burst pressure. EMERGE PTCA Dilatation Catheter. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). All rights reserved. U~ S?)DO(X`dpHpEjq[p10Lv1 Hjer8(,mArFFzMfzSdZn8,=}SGp=!x2|6eCjoVJfPb*K=]Q b?s/=2>I*6yeO-+7Xb{C/^9)#/> # Tu[sS*[eWc!Z9PEPW-OG#*vQJ*U' lK(^>EZoCq8VlS6>s$i \s#zG=?O4E Access our instructions for use and product manuals library. Balloon catheter retrieval methods (use of additional wires, snares, and/or forceps) may result in trauma to the treated vessel and/or the vascular access site. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. %%EOF A sales representive will get in touch with you shortly. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. 2792 0 obj <>/Filter/FlateDecode/ID[<8422C93A02CE4B499E7EC15CE70ACD24>]/Index[2785 21]/Info 2784 0 R/Length 60/Prev 713660/Root 2786 0 R/Size 2806/Type/XRef/W[1 3 1]>>stream Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. Boston Scientific, www.bostonscientific.com . MRI is a more detailed tool than x-ray and ultrasound and for certain organs or areas of the body, it provides better images than CT. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. In addition to this commitment, our robust research and teaching programs keep our hospital on the cutting-edge, while pushing medical care into the future. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729802976 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Several of these demonstrated magnetic field interactions. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. ZGlide hydrophilic coating reduces frictional force on the catheter shaft by 51% in bench tests, Unique, over-the-inner tip design: outer tip material rides over the inner shaft material and is designed to improve overall flexibility and tip performance, Profiles: Ultra-low 0.017 tip profile and 0.026 crossing profile, Balloon Material: OptiLEAP balloon material provides sizing flexibility, Platinum marker bands provide optimal radiopacity. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Find products, medical specialty information, and education opportunities. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. The Neuroform (Boston Scientific Corporation, Natick, MA) stent is a self-expanding nitinol stent designed to assist the endovascular placement of detachable coils in wide-necked intracranial aneurysms ( 1, 2 ). Most people are able to complete the exam easily, but for those who are uncomfortable, there are staff trained to assist them in completing the exam through relaxation and visualization techniques. Data on file. Safety Info ID# Safety Topic / Subject Article Text 171: Coils, Filters, Stents, and Grafts: Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. Do not expose the delivery system to organic solvents, e.g., alcohol. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. Many exams involve IV contrast, which helps highlight the tissues and give the radiologist different information about an area(s) of interest to help make a diagnosis. Coronary artery spasm in the absence of a significant stenosis. Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. All stents should be deployed in accordance with the manufacturers indications and instructions for use. endstream endobj 2789 0 obj <>stream Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Find out who we are, explore careers at the company, and view our financial performance. Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . The Freedom from TLR rate at 36 months was 88.1%. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. 2805 0 obj <>stream The stent is not designed for repositioning or recapturing. 2023 Boston Scientific Corporation or its affiliates. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. %PDF-1.7 % Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. During system flushing, observe that saline exits at the catheter tip. Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. The C-Code used forNC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan Do not expand the balloon if it is not properly positioned in the vessel. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . BMC physicians are leaders in their fields with the most advanced medical technology at their fingertips and working alongside a highly skilled nursing and professional staff. Disposable devices intended to assist implantation may be included. The Resolute Onyx stent is comprised of a bare metal stent with a Parylene C primer coat and a coating that consists of a blend of the drug zotarolimus and the BioLinx polymer system. People scheduled for an MRI should expect to be at BMC for about 1-1.5 hours. Find products, medical specialty information, and education opportunities. 2023 Boston Scientific Corporation or its affiliates. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. Available in sizes from 1.2 mm to 4.0 mm. Coils, Filters, Stents, and Grafts More. The NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters (balloon models 2.00- 5.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting). EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. The Venovo Venous Stent System is supplied sterile and is intended for single use only. 2023 Boston Medical Center. The delivery system is not designed for use with power injection systems. Bench tests may not be indicative of clinical performance. Data on File. Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. The device is typically intended for long-term, but not permanent, implantation. 44, no. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. GMDN Names and Definitions: Copyright GMDN Agency 2015. Remove the delivery system and replace with a new unit. 1.5 . Prior to stent deployment, remove slack from the delivery system catheter outside the patient. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q MRI may not be recommended if for people who have a pacemaker or other metal implants. One Boston Medical Center Place This depends on the exam the doctor has ordered. 98 subjects x-rays were analyzed and no stent fractures were reported. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729861720 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers We host and take part in events that excel in advancing the world of health. GMDN Names and Definitions: Copyright GMDN Agency 2015. MRI is a more detailed tool than x-ray and ultrasound and for certain organs or areas of the body, it provides better images than CT. o. Find out who we are, explore careers at the company, and view our financial performance. Missing x-ray analyses were recorded as protocol deviations. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. $ fG1012p("3| 2 Do not attempt to break, damage, or disrupt the stent after placement. The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. PMA Applicant: Boston Scientific Corporation Address: One Scimed Place, Maple Grove, MN 55311-1566 Approval Date: August 11, 2020 Approval Letter: Approval Order What is it? Whether youre a current employee or looking to refer a patient, we have the tools and resources you need to help you care for patients effectively and efficiently. Find products, medical specialty information, and education opportunities. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. ;;>BFZQC. At the 36-month follow-up, the CIVIQ-20 assessment demonstrated a change from baseline in the total study population of -16.8 and, for the VCSS Pain score, a change from baseline in the total population of -1.8. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. For more information about these cookies and the data collected, please refer to our, Laboratory and Biorepository Research Services Core, Pediatric Exams with and without conscious sedation. Results shown as averages measured in N/mm as follows (n=6): Venovo Venous Stent System (0.126), Medtronic Abre Venous Stent (0.1035), Cook Zilver Vena (0.063) and Boston Scientific VICI VENOUS STENT (0.054). 2023 BD. Data on file. 3Foreshortening is calculated as the difference, represented as percentage, between the compressed stent length and expanded stent length at minimum/maximum oversize (1-3 mm). 2=[DE8m|E23 jIrL|bW30+;$12r+e5Jl+]pVIn[Ndck0xc$VVq+9e'0")m275ahsk8/` $4,,:8X3@$3h` u40y@p ` i;+:dXf`6@,ohH=`)35^7;7>n`pRwg 1hQb`br&Y' 6G Data on file, BD Peripheral Intervention, Tempe, AZ. Store in a cool, dark, dry place. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. Premarket Submission Number Not Available/Not Released, Device Size Text, specify: 4.8 F Stent Diameter, Device Size Text, specify: 24 cm Effective Length, Device Size Text, specify: 1.6 mm Stent Diameter. Brand Name: Polaris Ultra Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729754565 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Ureteral Stent Polaris Ultra - Device Characteristics Polaris Ultra - GMDN Reuse, resterilization, reprocessing and/or repackaging may create a risk to the patient or user, may lead to infection or compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness, or death of the patient. Disposable devices intended to assist implantation may be included. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The safety and effectiveness of this device for use in the arterial system have not been established. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. To assess the safety and effectiveness of the Venovo Venous Stent BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. Reusing this medical device bears the risk of cross-patient contamination as medical devices particularly those with long and small lumina, joints, and/or crevices between components are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. Potential adverse events (in alphabetical order) that may be associated with the use of a PTCA Dilatation Catheter include, but are not limited to, the following: Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.

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