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). Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. The SYNERGY. The technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. MRI may not be recommended if for people who have a pacemaker or other metal implants. Different test methods may yield different results. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. 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. Missing x-ray analyses were recorded as protocol deviations. 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. TLR is defined as the first revascularization procedure in the target vessel(s) following the index procedure, as determined by an Independent Core Lab. Do not use if pouch is opened or damaged. 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. All stents should be deployed in accordance with the manufacturers indications and instructions for use. Reproduced with Permission from the GMDN Agency. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. 1.5, 3: Conditional 5 More. Data on file. Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP 2023 Boston Scientific Corporation or its affiliates. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. alcohol or nitroglycerine, stem cells, etc.) hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q Bench test results may not necessarily be indicative of clinical performance. 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. All rights reserved. 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). 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. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. Disposable devices intended to assist implantation may be included. 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 The device is typically intended for long-term, but not permanent, implantation. Data on file. 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. One Boston Medical Center Place Do not attempt to break, damage, or disrupt the stent after placement. Data on file, BD Peripheral Intervention, Tempe, AZ. 2023 BD. To assess the safety and effectiveness of the Venovo Venous Stent An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. Access our instructions for use and product manuals library. Several of these demonstrated magnetic field interactions. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. 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. Find products, medical specialty information, and education opportunities. 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). The long-term outcomes following repeat dilatation of endothelialized stents are unknown. Premarket Submission Number Not Available/Not Released. All rights reserved. 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. Reproduced with Permission from the GMDN Agency. Find out who we are, explore careers at the company, and view our financial performance. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. 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. 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. $ fG1012p("3| 2 Staff also needs to know specific details about any implants in the body. 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. MRI also has one exam that uses oral contrast to help visualize the digestive track. Dake, Michael D, et al. 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). During system flushing, observe that saline exits at the catheter tip. To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Testing completed by Boston Scientific Corporation. Store in a cool, dark, dry place. Coronary artery spasm in the absence of a significant stenosis. Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. EMERGE PTCA Dilatation Catheter. Do not resterilize and/or reuse the device. The safety and effectiveness of this device for use in the arterial system have not been established. 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 To obtain copies images, please call the film library at 617.414.5882. Data on file. 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. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. 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. o. This site is Exclusively Sponsored by BRACCO. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 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. 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. 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. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. 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. We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. All other trademarks are the property of their respective owners. Directions for Use. through the guidewire lumen, other than those required for normal use. Coils, Filters, Stents, and Grafts More. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. All rights reserved. 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 ). 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. If excessive force is felt during stent deployment, do not force the delivery system. The average MRI exam takes about 45 minutes. 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. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. 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. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . GMDN Names and Definitions: Copyright GMDN Agency 2015. All rights reserved. Data on file. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. 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. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The Venovo Venous Stent System is supplied sterile and is intended for single use only. Boston Scientific, www.bostonscientific.com . The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. 617.638.8000. Several of these demonstrated magnetic field interactions. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. 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 MRI Information For Healthcare Professionals For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. 0 Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. 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 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). For both in-person and virtual visits, BMC is here to ensure you have everything you need to make your visit a success. 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. ;;>BFZQC. Data on file. 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. Recorded at the London Charing Cross Symposium in 2019. 2023 Boston Scientific Corporation or its affiliates. Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Do not expose the delivery system to organic solvents, e.g., alcohol. All other trademarks are the property of their respective owners. Once the test has been completed people can return home and resume normal activities. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. Find products, medical specialty information, and education opportunities. 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. Epub 2021 Sep 20. Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . For decades, we have worked together to define the future. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. Patients must remain still and quiet for the entire exam, as any movement, even speaking, can make the images blurry. 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? We host and take part in events that excel in advancing the world of health. 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. 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. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. This depends on the exam the doctor has ordered. The compatibility of the device has not been evaluated for the delivery of materials (e.g. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Testing completed by Boston Scientific Corporation. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). We are committed to providing the best experience possible for our patients and visitors. Do not use the device with contralateral access. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. 2023 Boston Medical Center. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. 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. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 850 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. %PDF-1.7 % Data on file. The stent is not designed for repositioning or recapturing. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). The device is typically intended for long-term, but not permanent, implantation. 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. 2023 Boston Scientific Corporation or its affiliates. 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. The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. 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. The image is highly detailed and can show even the smallest abnormality. CAUTION: The law restricts these devices to sale by or on the order of a physician. Do not expand the balloon if it is not properly positioned in the vessel. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous Find products, medical specialty information, and education opportunities. Choose from Monorail and Over-the-Wire Catheter options. 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). 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 Note: Boston Scientific Corporation is not responsible for correct use of codes on .

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