Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). 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. Find products, medical specialty information, and education opportunities. Find products, medical specialty information, and education opportunities. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. Find products, medical specialty information, and education opportunities. Do not attempt to break, damage, or disrupt the stent after placement. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. Receive Updates. through the guidewire lumen, other than those required for normal use. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. To obtain copies images, please call the film library at 617.414.5882. Bench test results may not necessarily be indicative of clinical performance. 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. 2023 Boston Medical Center. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! 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 Do not resterilize and/or reuse the device. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. Disposable devices intended to assist implantation may be included. Premarket Submission Number Not Available/Not Released. 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. $ fG1012p("3| 2 For decades, we have worked together to define the future. 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. 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. Testing completed by Boston Scientific Corporation. 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. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. 2023 Boston Scientific Corporation or its affiliates. outflow obstruction. endstream endobj 2789 0 obj <>stream 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). Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. Boston Scientific, www.bostonscientific.com . Stents were evaluated at the 36-month follow-up for fracture analysis. for the treatment of iliofemoral venous occlusive disease. Coils, Filters, Stents, and Grafts More. Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. 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. Once the test has been completed people can return home and resume normal activities. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. We are committed to providing the best experience possible for our patients and visitors. 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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). 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). For both in-person and virtual visits, BMC is here to ensure you have everything you need to make your visit a success. 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. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. 98 subjects x-rays were analyzed and no stent fractures were reported. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. 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 Find out who we are, explore careers at the company, and view our financial performance. 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. 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. 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. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. Remove the delivery system and replace with a new unit. All stents should be deployed in accordance with the manufacturers indications and instructions for use. MRI exams require people to lie still for the entire length of the study. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. GMDN Names and Definitions: Copyright GMDN Agency 2015. Access our instructions for use and product manuals library. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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". Find out who we are, explore careers at the company, and view our financial performance. 2805 0 obj <>stream Do not use the device with contralateral access. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 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. Shellock R & D Services, Inc. email: [email protected]. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. 1.5, 3: Conditional 5 More. %PDF-1.7 % MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. 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. o. The safety and effectiveness of this device for use in the arterial system have not been established. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. Do not expand the balloon if it is not properly positioned in the vessel. Shellock R & D Services, Inc. email: [email protected]. Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. MRI may not be recommended if for people who have a pacemaker or other metal implants. 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. The device is intended for use by physicians who have received appropriate training. 2023 Boston Scientific Corporation or its affiliates. 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. Note: Boston Scientific Corporation is not responsible for correct use of codes on . Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. 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. Data on file, BD Peripheral Intervention, Tempe, AZ. The stent is not designed for repositioning or recapturing. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. Do not use if pouch is opened or damaged. We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. Patients must remain still and quiet for the entire exam, as any movement, even speaking, can make the images blurry. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q 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. Data on file. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. 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. Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. 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 We host and take part in events that excel in advancing the world of health. 2023 Boston Scientific Corporation or its affiliates. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Find products, medical specialty information, and education opportunities. MRI also has one exam that uses oral contrast to help visualize the digestive track. All rights reserved. All rights reserved. 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. The device is typically intended for long-term, but not permanent, implantation. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. 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? EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. This site is Exclusively Sponsored by BRACCO. 617.638.8000. 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. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). A sales representive will get in touch with you shortly. Available in sizes from 1.2 mm to 4.0 mm. BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. 1.5,3: Safe More. The C-Code used forNC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Directions for Use. endstream endobj startxref 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. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. People scheduled for an MRI should expect to be at BMC for about 1-1.5 hours. 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. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. endstream endobj 2786 0 obj <>/Metadata 132 0 R/Outlines 189 0 R/Pages 2783 0 R/StructTreeRoot 192 0 R/Type/Catalog/ViewerPreferences 2793 0 R>> endobj 2787 0 obj <>/MediaBox[0 0 288 648]/Parent 2783 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 2788 0 obj <>stream 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. Dake, Michael D, et al. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. 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. Boston Scientific, www.bostonscientific.com, Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur, AAA Endograft Ovation Ovation Abdominal Stent Graft System TriVascular2, Inc. Santa Rosa, CA, Abre StentMedtronic, Inc., www.Medtronic.com/MRI, Absolute .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, ABSOLUTE 0.35 Biliary Self Expanding Stent System Guidant http://www.guidant.com/ifu/, Absolute Biliary StentAbbott Vascularwww.abbottvascular.com, Absolute Pro .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, Absolute Pro Peripheral Stent Abbott Vascular www.Abbott.com, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 120-mm Single version Abbott Vascular Santa Clara, CA, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 348-mm three overlapped version Abbott Vascular Santa Clara, CA, ABSOLUTE Biliary Self-Expanding Stent System Nitinol coils, filters, stents Guidant Endovascular Solutions Santa Clara, CA, Absorb Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular, www.abbottvascular.com, Absorb GT1 Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular,www.abbottvascular.com, Acculink Carotid StentAbbott Vascularwww.abbottvascular.com, ACCULINK Carotid StentGuidanthttp://www.guidant.com/ifu/, ACS MULTI-LINK Coronary StentAbbott Vascularwww.abbottvascular.com, ACS MULTI-LINK DUET Coronary StentAbbott Vascularwww.abbottvascular.com. 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). If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). CAUTION: The law restricts these devices to sale by or on the order of a physician. 44, no. Staff also needs to know specific details about any implants in the body. BD and the BD Logo are trademarks of Becton, Dickinson and Company. Data on File. If excessive force is felt during stent deployment, do not force the delivery system. Disposable devices intended to assist implantation may be included. By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. hbbd```b``>"tH/ MARLBOROUGH, Mass., April 26, 2023 / PRNewswire / -- Boston Scientific Corporation (NYSE: BSX) generated net sales of $3.389 billion during the first quarter of 2023, growing 12.0 percent on a reported basis, 14.9 percent on an operational 1 basis and 14.0 percent on an organic 2 basis, all compared to the prior year period. 0 The Neuroform (Boston Scientific Corporation, Natick, MA) stent is a self-expanding nitinol stent designed to assist the endovascular placement of detachable coils in wide-necked intracranial aneurysms ( 1, 2 ). Store in a cool, dark, dry place. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. Kaplan-Meier Primary Patency in Post-Thrombotic Lesions at 36 months, Kaplan-Meier Primary Patency in Non-Thrombotic Lesions at 36 months, Freedom from Target Lesion Revascularization (TLR) at 36 months. %%EOF Do not use the device after the Use By date specified on the label. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Safety Info ID# Safety Topic / Subject Article Text 171: Coils, Filters, Stents, and Grafts: Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. U~ S?)DO(X`dpHpEjq[p10Lv1 Hjer8(,mArFFzMfzSdZn8,=}SGp=!x2|6eCjoVJfPb*K=]Q b?s/=2>I*6yeO-+7Xb{C/^9)#/> # Tu[sS*[eWc!Z9PEPW-OG#*vQJ*U' lK(^>EZoCq8VlS6>s$i \s#zG=?O4E Data on file. 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. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established.
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