MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. 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 1.5, 3: Conditional 5 More. Find out who we are, explore careers at the company, and view our financial performance. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! 2023 Boston Scientific Corporation or its affiliates. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. All rights reserved. Data on file. TLR is defined as the first revascularization procedure in the target vessel(s) following the index procedure, as determined by an Independent Core Lab. through the guidewire lumen, other than those required for normal use. Never use air or any gaseous medium to inflate the balloon. 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. 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 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. 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. for the treatment of iliofemoral venous occlusive disease. 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. 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). Reproduced with Permission from the GMDN Agency. hUmo0+}B~Dx&~XQT,%DN nU|w{p This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q 1.5,3: Safe More. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. This depends on the exam the doctor has ordered. We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. Fortunately, the devices that exhibited po . Directions for Use. 2023 Boston Scientific Corporation or its affiliates. Data on file. 2805 0 obj <>stream For both in-person and virtual visits, BMC is here to ensure you have everything you need to make your visit a success. 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. To obtain copies images, please call the film library at 617.414.5882. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. 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. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. 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 BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. Boston, MA 02118 Several of these demonstrated magnetic field interactions. One Boston Medical Center Place Data on file. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information 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. 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. We host and take part in events that excel in advancing the world of health. The device is typically intended for long-term, but not permanent, implantation. We are committed to providing the best experience possible for our patients and visitors. Missing x-ray analyses were recorded as protocol deviations. Find products, medical specialty information, and education opportunities. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. MRI may not be recommended if for people who have a pacemaker or other metal implants. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . Then the patient is brought out of the scanner. ;;>BFZQC. Data on file. 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. Disposable devices intended to assist implantation may be included. 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 average MRI exam takes about 45 minutes. 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. 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. Do not exceed the balloon rated burst pressure. 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? 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. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. 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. 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. Once the test has been completed people can return home and resume normal activities. 2785 0 obj <> endobj The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Bench test results may not necessarily be indicative of clinical performance. 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. 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. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. All rights reserved. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. 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. Find out who we are, explore careers at the company, and view our financial performance. Boston Scientific, www.bostonscientific.com . Stents were evaluated at the 36-month follow-up for fracture analysis. Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. GMDN Names and Definitions: Copyright GMDN Agency 2015. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. 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". With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. 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. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. Disposable devices intended to assist implantation may be included. 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 The delivery system is not designed for use with power injection systems. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. Patients having an enterography, may be at BMC up to 3 hours. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. 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. Several of these demonstrated magnetic field interactions. 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. 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. All rights reserved. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. All rights reserved. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. 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. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. outflow obstruction. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. 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 The safety and effectiveness of this device for use in the arterial system have not been established. Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. $ fG1012p("3| 2 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. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). 2023 Boston Scientific Corporation or its affiliates. Coils, Filters, Stents, and Grafts More. 0 PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication. 2023 BD. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. Do not expand the balloon if it is not properly positioned in the vessel. Do not attempt to break, damage, or disrupt the stent after placement. Find products, medical specialty information, and education opportunities. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. 44, no. 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. Do not use the device with contralateral access. 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. MRI exams require people to lie still for the entire length of the study. 98 subjects x-rays were analyzed and no stent fractures were reported. 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. 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. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. The long-term outcomes following repeat dilatation of endothelialized stents are unknown. o. Find out who we are, explore careers at the company, and view our financial performance. 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. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. 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 radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. 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 typically intended for long-term, but not permanent, implantation. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . Polaris Ultra Ureteral Stent BD and the BD Logo are trademarks of Becton, Dickinson and Company. 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 is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The SYNERGY. 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. Find products, medical specialty information, and education opportunities. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. 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. 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. All rights reserved. Note: Boston Scientific Corporation is not responsible for correct use of codes on . Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. 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. The Venovo Venous Stent System is supplied sterile and is intended for single use only. The ordering physician will go over the findings with their patient. 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). All other trademarks are the property of their respective owners. Data on file, BD Peripheral Intervention, Tempe, AZ. Data on file. To assess the safety and effectiveness of the Venovo Venous Stent 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. If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). 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. People scheduled for an MRI should expect to be at BMC for about 1-1.5 hours. Data on file. Epub 2021 Sep 20. 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.
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