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. Do not use if pouch is opened or damaged. The Freedom from TLR rate at 36 months was 88.1%. All rights reserved. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. Note: Boston Scientific Corporation is not responsible for correct use of codes on . Then the patient is brought out of the scanner. The technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. 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. $ fG1012p("3| 2 Find out who we are, explore careers at the company, and view our financial performance. 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 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. Stents were evaluated at the 36-month follow-up for fracture analysis. 617.638.8000. alcohol or nitroglycerine, stem cells, etc.) 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. We are committed to providing the best experience possible for our patients and visitors. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. Testing completed by Boston Scientific Corporation. 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 The ordering physician will go over the findings with their patient. Testing completed by Boston Scientific Corporation. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Access our instructions for use and product manuals library. 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. Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 2023 BD. 2023 Boston Medical Center. 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). C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. The average MRI exam takes about 45 minutes. 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). All rights reserved. Data on file. 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. Bench tests may not be indicative of clinical performance. MRI also has one exam that uses oral contrast to help visualize the digestive track. The device is typically intended for long-term, but not permanent, implantation. Several of these demonstrated magnetic field interactions. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Data on file. 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. All rights reserved. Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. 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. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. The delivery system is not designed for use with power injection systems. 1.5, 3: Conditional 5 More. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Coils, Filters, Stents, and Grafts More. Dake, Michael D, et al. The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. 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). 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 ). 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. 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. 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. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. for the treatment of iliofemoral venous occlusive disease. The SYNERGY. Data on file. Remove the delivery system and replace with a new unit. For decades, we have worked together to define the future. All stents should be deployed in accordance with the manufacturers indications and instructions for use. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information 98 subjects x-rays were analyzed and no stent fractures were reported. Reproduced with Permission from the GMDN Agency. Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . Choose from Monorail and Over-the-Wire Catheter options. Do not use the device after the Use By date specified on the label. Coils, Filters, Stents, and Grafts More. Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. 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 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). We host and take part in events that excel in advancing the world of health. 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. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. 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 Once the test has been completed people can return home and resume normal activities. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. 44, no. Epub 2021 Sep 20. 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. 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. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. All rights reserved. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Find products, medical specialty information, and education opportunities. If excessive force is felt during stent deployment, do not force the delivery system. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). Available in sizes from 1.2 mm to 4.0 mm. 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. Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan 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. MRI exams require people to lie still for the entire length of the study. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. 2023 Boston Scientific Corporation or its affiliates. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. 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. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. Data on file. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. TLR is defined as the first revascularization procedure in the target vessel(s) following the index procedure, as determined by an Independent Core Lab. 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. Do not use the device with contralateral access. endstream endobj 2789 0 obj <>stream Disposable devices intended to assist implantation may be included. Store in a cool, dark, dry place. Data on file. Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. 2023 Boston Scientific Corporation or its affiliates. o. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. 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. 1.5,3: Safe More. 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. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. endstream endobj startxref The safety and effectiveness of this device for use in the arterial system have not been established. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. 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. During system flushing, observe that saline exits at the catheter tip. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. 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. All other trademarks are the property of their respective owners. Fortunately, the devices that exhibited po . Do not exceed the balloon rated burst pressure. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. BD and the BD Logo are trademarks of Becton, Dickinson and Company. MRI may not be recommended if for people who have a pacemaker or other metal implants. The compatibility of the device has not been evaluated for the delivery of materials (e.g. outflow obstruction. ;;>BFZQC. The long-term outcomes following repeat dilatation of endothelialized stents are unknown. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Do not attempt to break, damage, or disrupt the stent after placement. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The device is intended for use by physicians who have received appropriate training. All rights reserved. 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. The Venovo Venous Stent System is supplied sterile and is intended for single use only. Coronary artery spasm in the absence of a significant stenosis. A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). Wallstent EndoprosthesisMagic Wallstent3.5 x 25coil, stent, filterSchneider (USA) Inc.Pfizer Medical Technology GroupMinneapolis, M, Wallstent EndoprosthesisWith Permalume covering8 x 80coil, stent, filterSchneider (USA) Inc.Minneapolis, M, Wallstent Esophageal II Endoprosthesis20 x 130coil, stent, filterSchneider (USA) Inc.Pfizer Medical Technology GroupMinneapolis, M, WALLSTENT RX Biliary EndoprosthesisBoston Scientifichttp://www.bostonscientific.com, WALLSTENT Venous, Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com, WallStentcarotid artery stentBoston Scientific CorporationMaple Grove, MN, Wallstentplatinum and cobalt-alloycoil, stent, filterSchneiderBulach, Switzerland, Walvekar Salivary Duct StentHood Laboratories, www.hoodlabs.com, Watchman Gen 4 ImplantAtritech Inc. and Boston Scientific, www.bostonscientific.com, Watchman Left Atrial Appendage Closure DeviceAtritech Inc. and Boston Scientific, www.bostonscientific.com, WEB Aneurysm Embolization Device Sequent Medical, Inc./Microvention, www.microvention.com, Weck Horizon, Titanium Clip, All sizes Teleflex Medical, www.teleflex.com, WedgeLoc Suture Anchor with Opti-Fiber SuturesMedShape SolutionsAtlanta, GA, WedgeLoc Suture AnchorMedShape Solutions, Inc.Atlanta, GA, Wehrs Incus Prosthesis, Otologic ImplantGyrus ACMI, www.gyrusacmi.com, WessexAortic, Model WAV10heart valveSorin BiomedicaItaly, WessexMitral, Model WMV20heart valveSorin BiomedicaItaly, Westaby T-Y StentHood Laboratories, www.hoodlabs.com, Western EZ-OX Plus SystemALQ-2342 on an Aluminum D cylinderWestern EnterprisesWestlake, OH. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. Recorded at the London Charing Cross Symposium in 2019. 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. To assess the safety and effectiveness of the Venovo Venous Stent Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Data on file. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. 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. Data on File. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . 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. Boston Scientific, www.bostonscientific.com . GMDN Names and Definitions: Copyright GMDN Agency 2015. CAUTION: The law restricts these devices to sale by or on the order of a physician. Different test methods may yield different results. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. The stent is not designed for repositioning or recapturing. Boston, MA 02118 0 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. 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". 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. 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. %%EOF BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP Reproduced with Permission from the GMDN Agency. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. 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. Find out who we are, explore careers at the company, and view our financial performance. 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.

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