Do not use the device with contralateral access. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. Remove the delivery system and replace with a new unit. Find products, medical specialty information, and education opportunities. Available in sizes from 1.2 mm to 4.0 mm. Because the MRI has a powerful magnetic field, patients will be screened and checked to make absolutely sure they dont have any metal objects with them before entering the scan room. Find products, medical specialty information, and education opportunities. The primary effectiveness endpoint of the study was primary patency (PP) at 12 months post-index procedure, defined as: freedom from TVR and freedom from thrombus occlusion and stenosis > 50% as measured by DUS. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. 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. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Dr. Michael Dake, Senior VP for Health Sciences at the University of Arizona and Principal Investigator in the VenovoVenous Stent VERNACULAR trial shares key findings from the 24-month clinical results including primary patency rates, target lesion revascularization (TLR) and fracture rates, patient quality of life, and more. hbbd```b``>"tH/ 2023 Boston Scientific Corporation or its affiliates. MARLBOROUGH, Mass., April 26, 2023 / PRNewswire / -- Boston Scientific Corporation (NYSE: BSX) generated net sales of $3.389 billion during the first quarter of 2023, growing 12.0 percent on a reported basis, 14.9 percent on an operational 1 basis and 14.0 percent on an organic 2 basis, all compared to the prior year period. Patients who received a Venovo Venous Stent had a weighted PP rate of 88.6%, demonstrating a statistically significant difference from a literature-derived performance goal (PG) of 74%, with an 81.7% PP rate for subjects with post-thrombotic syndrome and 97.1% PP rate for subjects with non-thrombotic iliac vein lesions. Staff also needs to know specific details about any implants in the body. CAUTION: The law restricts these devices to sale by or on the order of a physician. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. Do not expand the balloon if it is not properly positioned in the vessel. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Different test methods may yield different results. 2023 Boston Scientific Corporation or its affiliates. All rights reserved. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. 170 subjects at 21 sites in the U.S., Europe, and Australia/New Zealand, * Evaluated against literature derived performance goal of 74% for efficacy (p<.0001) and 89% for safety (p=.032), 1The Venovo Venous Stent System was studied in the global VERNACULAR clinical trial, which was a prospective, multi-center, non-randomized, single-arm study of 170 patients. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan alcohol or nitroglycerine, stem cells, etc.) MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. See all healthcare professional information, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EMERGE PTCA Dilatation Catheter - Boston Scientific, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information, Exceptional deliverability and low profiles designed to cross tight lesions, High rated burst pressure 18 ATM (1824 kPa) for sizing flexibility, Two shaft designs provide options for challenging lesions, EMERGE Catheter is designed for exceptional simultaneous use performance, Shaft profile allows for simultaneous use of two Monorail catheters in a 6 F guide catheter and two Over-the-Wire catheters in an 8 F guide catheter*, Designed to optimize stent apposition in large, proximal vessels, Two shaft options with distinct technologies designed to provide flexibility for navigating to and through even the most challenging lesions, Push technology: Single-segment inner shaft design for ultimate pushability 1.2 mm and 1.5 mm Push, Workhorse technology: Bi-Segment inner shaft designed for maximum deliverability without sacrificing pushability (1.2 mm to 4.0 mm). %%EOF In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. People who are claustrophobic, should consult their physician prior to the day of the appointment for assistance, as the department is not licensed to dispense medication. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. Testing completed by Boston Scientific Corporation. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Polaris Ultra Ureteral Stent 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. Once the test has been completed people can return home and resume normal activities. Data on file. Recorded at the London Charing Cross Symposium in 2019. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. 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. The safety and effectiveness of this device for use in the arterial system have not been established. The NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 Coils, Filters, Stents, and Grafts More. endstream endobj 2789 0 obj <>stream We offer diagnosis and treatment in over 70 specialties and subspecialties, as well as programs, services, and support to help you stay well throughout your lifetime. Find out who we are, explore careers at the company, and view our financial performance. endstream endobj startxref 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 ). 850 W Rio Salado Pkwy, Tempe, AZ 85281 United States, 6:00 a.m. 4:30 p.m. Arizona Time (Monday-Friday), Surgical Instruments and Sterilization Container products. Disposable devices intended to assist implantation may be included. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. Safe MR imaging involves a careful initial patient screening, accurate determination of the permanent implanted or temporary cardiovascular device and its properties, a thoughtful analysis of the risks and benefits of performing the examination at that time, and, when indicated, appropriate physician management and supervision. ;;>BFZQC. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 2023 BD. Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . We host and take part in events that excel in advancing the world of health. Coils, Filters, Stents, and Grafts More. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information Fortunately, the devices that exhibited po . A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. For people having an enterography exam, they will be given an oral contrast as well and will need to wait 2 hours after drinking it to allow it to coat their intestines completely. The average MRI exam takes about 45 minutes. Data on file. 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. 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. 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). The long-term outcomes following repeat dilatation of endothelialized stents are unknown. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. 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 Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, *6 F guide catheter with a minimum 0.070" ID, 8 F guide catheter with a minimum 0.088" ID, See all healthcare professional information, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information, Improves overall flexibility and performance in tortuous anatomy, Outer tip material rides over the inner shaft, Designed to improve overall flexibility and tip performance, Short tip designed to lessen tip catch occurrence and offer greater control, Designed for exceptional simultaneous use performance, Reduced frictional force on the catheter shaft, Both stiff and flexible segments to enhance pushability and trackability, One piece outer shaft provides a seamless transition, Designed for less balloon growth and increased rated, Unique blend of balloon materials provides excellent, Provides optimal radiopacity and excellent visibility. People scheduled for an MRI should expect to be at BMC for about 1-1.5 hours. BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP Allergic/anaphylactic reaction; Amputation; Aneurysm; Arteriovenous fistula; Death related/unrelated to procedure; Dissection; Embolization; Extravasation; Fever; Hemorrhage/bleeding requiring a blood transfusion; Hematoma; Hypotension/hypertension; Incorrect positioning of the stent requiring further stenting or surgery; Intimal injury/dissection; Ischemia/infarction of tissue/organ; Local infection; Malposition (failure to deliver the stent to the intended site); Open surgical repair; Pain; Pulmonary embolism; Pseudoaneurysm; Renal failure; Respiratory arrest; Restenosis; Rupture; Septicemia/bacteremia; Stent Fracture; Stent Migration; Vasospasm; Venous occlusion/thrombosis/restenosis. Do not use if pouch is opened or damaged. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. 1.5,3: Safe More. The SYNERGY. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. Do not expose the delivery system to organic solvents, e.g., alcohol. 0 PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). 617.638.8000. By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. 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. To obtain copies images, please call the film library at 617.414.5882. This site is Exclusively Sponsored by BRACCO. 2023 Boston Scientific Corporation or its affiliates. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. 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 arrhythmia, including ventricular fibrillation, coronary vessel dissection, perforation, rupture or injury, possibly requiring surgical repair or intervention, drug reactions, including allergic reaction to contrast medium, total occlusion of the coronary artery or bypass graft, vessel trauma requiring surgical repair or intervention, See all healthcare professional information, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. Patients having an enterography, may be at BMC up to 3 hours. Directions for Use. The stent is not designed for repositioning or recapturing. Bench test results may not necessarily be indicative of clinical performance. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! Then the patient is brought out of the scanner. Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. Data on File. 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? Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. 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 One Boston Medical Center Place The device is typically intended for long-term, but not permanent, implantation. Dake, Michael D, et al. Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . Find out who we are, explore careers at the company, and view our financial performance. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). All stents should be deployed in accordance with the manufacturers indications and instructions for use. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. outflow obstruction. Never use air or any gaseous medium to inflate the balloon. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. 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. Store in a cool, dark, dry place. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. The Venovo Venous Stent System is contraindicated for use in patients with a known hypersensitivity to nitinol (nickel-titanium) and tantalum, who cannot receive intraprocedural anti-coagulation therapy, or who are judged to have a lesion that prevents complete inflation of a balloon dilatation catheter or proper placement of the stent or the stent delivery system. Polymeric ureteral stent 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 All rights reserved. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. Find out who we are, explore careers at the company, and view our financial performance. Do not attempt to break, damage, or disrupt the stent after placement. The NC Emerge PTCA Dilatation Catheter is contraindicated for use in: PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful consideration, including possible hemodynamic support during PTCA as treatment of this patient population carries special risk. 2785 0 obj <> endobj Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. Boston, MA 02118 BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. During system flushing, observe that saline exits at the catheter tip. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. MRI may not be recommended if for people who have a pacemaker or other metal implants. %PDF-1.7 % Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Bench tests may not be indicative of clinical performance. All other trademarks are the property of their respective owners. hUmo0+}B~Dx&~XQT,%DN nU|w{p Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. For decades, we have worked together to define the future. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. 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. We are committed to providing the best experience possible for our patients and visitors. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. 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. Data on file, BD Peripheral Intervention, Tempe, AZ. There is no preparation necessary for an MRI except for people having an exam called an MRCP, an exam of the gallbladder and the ducts associated with it, or an enterography. Coronary artery spasm in the absence of a significant stenosis. BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. Bench test results may not necessarily be indicative of clinical performance. Premarket Submission Number Not Available/Not Released. Do not exceed the balloon rated burst pressure. 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. for the treatment of iliofemoral venous occlusive disease. A patient with the VICI VENOUS STENT can be scanned safely, immediately after placement, in an MR system meeting the following conditions: o Static magnetic field of 1.5 T or 3.0 T only. ESG (Environmental, Social, and Governance), Policies, Guidelines and Statements Center, Venous disease is complex, your stent choice doesn't have to be, Our live chat is available between the hours of 8.30am - 5.00pm EST, Monday - Friday, BD Original Equipment Manufacturing (OEM), Patient Care Support Across the Continuum, Engineered to provide the optimal balance between radial force, flexibility, and compression resistance, Tri-axial delivery system designed to provide accurate deployment to help facilitate optimal stent placement and lesion coverage, 3mm flared stent ends designed to reduce the risk of stent migration and maximize wall apposition. Reproduced with Permission from the GMDN Agency. All other trademarks are the property of their respective owners. We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. Testing completed by Boston Scientific Corporation. The device is intended for use by physicians who have received appropriate training. BD and the BD Logo are trademarks of Becton, Dickinson and Company. Find products, medical specialty information, and education opportunities.

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