Bench test results may not necessarily be indicative of clinical performance. 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. The stent is not designed for repositioning or recapturing. During system flushing, observe that saline exits at the catheter tip. 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. Find out who we are, explore careers at the company, and view our financial performance. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. 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). Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Boston Medical Center (BMC) is a 514-bed academic medical center located in Boston's historic South End, providing medical care for infants, children, teens and adults. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. 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. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Stents were evaluated at the 36-month follow-up for fracture analysis. Coils, Filters, Stents, and Grafts More. for the treatment of iliofemoral venous occlusive disease. 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. BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. outflow obstruction. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. 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? 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. Choose from Monorail and Over-the-Wire Catheter options. Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. alcohol or nitroglycerine, stem cells, etc.) NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. Do not expose the delivery system to organic solvents, e.g., alcohol. Then the patient is brought out of the scanner. A Deeper Dive into the Venovo Venous Stent System, PRESS RELEASE - MAR 14, 2019, PR NEWSWIRE, BD Receives U.S. FDA Approval for First Venous Stent to Treat Iliofemoral Venous Occlusive Disease, One-year data from venous stent registry "promising". The safety and effectiveness of this device for use in the arterial system have not been established. All rights reserved. Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan 1 The 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. 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. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. Available in sizes from 1.2 mm to 4.0 mm. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous 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 2805 0 obj <>stream 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. 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). C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. The patient will be asked to lie on their back or stomach, and should plan to be in the machine for at least 45 minutes in order to complete the exam. Find out who we are, explore careers at the company, and view our financial performance. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. The device is intended for use by physicians who have received appropriate training. 617.638.8000. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . 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. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Directions 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. 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). 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 Freedom from TLR rate at 36 months was 88.1%. All rights reserved. Find products, medical specialty information, and education opportunities. 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The device is typically intended for long-term, but not permanent, implantation. 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 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. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. 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. Reproduced with Permission from the GMDN Agency. 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. Testing completed by Boston Scientific Corporation. We are committed to providing the best experience possible for our patients and visitors. 1.5 . Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. All rights reserved. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. %%EOF Once in the scan room, the technologist will explain the exam before it begins and will give the patient ear plugs to muffle the noise the machine makes. 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. 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. Receive Updates. 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. 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. The technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. 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. Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. All rights reserved. Coils, Filters, Stents, and Grafts More. The delivery system is not designed for use with power injection systems. Never use air or any gaseous medium to inflate the balloon. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. 44, no. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Do not use if pouch is opened or damaged. 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. The technologist performing the exam will monitor the patient throughout the scan and they are also able to talk with each other the entire time. If excessive force is felt during stent deployment, do not force the delivery system. Several of these demonstrated magnetic field interactions. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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 ). 2023 Boston Medical Center. If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. This site is Exclusively Sponsored by BRACCO. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. Disposable devices intended to assist implantation may be included. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Recorded at the London Charing Cross Symposium in 2019. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. 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). To obtain copies images, please call the film library at 617.414.5882. Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. Remove the delivery system and replace with a new unit. 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. Bench tests may not be indicative of clinical performance. 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. Patients must remain still and quiet for the entire exam, as any movement, even speaking, can make the images blurry. Note: Boston Scientific Corporation is not responsible for correct use of codes on . Do not use the device after the Use By date specified on the label. The ordering physician will go over the findings with their patient. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. 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. Data on file, BD Peripheral Intervention, Tempe, AZ. $ fG1012p("3| 2 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). xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! GMDN Names and Definitions: Copyright GMDN Agency 2015. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. The C-Code used forNC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. Different test methods may yield different results. 2023 Boston Scientific Corporation or its affiliates. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. through the guidewire lumen, other than those required for normal use. All rights reserved. All rights reserved. All other trademarks are the property of their respective owners. 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 technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information All stents should be deployed in accordance with the manufacturers indications and instructions for use. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Staff also needs to know specific details about any implants in the body. The compatibility of the device has not been evaluated for the delivery of materials (e.g. Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . Store in a cool, dark, dry place. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP Once the scan is complete, the technologist will review the images to make sure all the information needed is there. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 2023 Boston Scientific Corporation or its affiliates. This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. Results demonstrated 100% acute technical success, defined as successful deployment of stent(s) to intended target with adequate lesion coverage as assessed by the Investigator at the time of the index procedure. Find products, medical specialty information, and education opportunities. Data on file. The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. Data on file. hbbd```b``>"tH/ Boston, MA 02118 Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. Data on file. MRI may not be recommended if for people who have a pacemaker or other metal implants. The image is highly detailed and can show even the smallest abnormality. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Missing x-ray analyses were recorded as protocol deviations. MRI exams require people to lie still for the entire length of the study. The average MRI exam takes about 45 minutes. 2023 Boston Scientific Corporation or its affiliates. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. Primary Patency by Kaplan-Meier estimates at 36 months are 84.0% for the total population (N=170), 74.8% for subjects with post-thrombotic syndrome (N=93) and 95.5% for subjects with non-thrombotic iliac vein lesions. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. 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.

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