Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Access our instructions for use and product manuals library. 1.5,3: Safe More. PDF VICI VENOUS STENT System Instructions for Use - Food and Drug Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Different test methods may yield different results. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. 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. Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. Receive Updates. 2023 BD. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . 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. Recorded at the London Charing Cross Symposium in 2019. One Boston Medical Center Place The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 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 Prior to stent deployment, remove slack from the delivery system catheter outside the patient. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). 2023 Boston Scientific Corporation or its affiliates. Magnetic Resonance Imaging (MRI) | Boston Medical Center 2023 Boston Scientific Corporation or its affiliates. Find out who we are, explore careers at the company, and view our financial performance. The ordering physician will go over the findings with their patient. This depends on the exam the doctor has ordered. 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. 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). All rights reserved. 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. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. 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. 1.5, 3: Conditional 5 More. 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. Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. 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 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. Bench tests may not be indicative of clinical performance. 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. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. PDF Summary of Safety and Effectivness (SSED)Template Bench test results may not necessarily be indicative of clinical performance. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 1.5 . 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. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 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. PDF Resolute Onyx Zotarolimus-Eluting Coronary Stent System Rapid Exchange Do not use the device after the Use By date specified on the label. 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 products, medical specialty information, and education opportunities. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. alcohol or nitroglycerine, stem cells, etc.) AccessGUDID - DEVICE: Ascerta (08714729802976) 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. AccessGUDID - DEVICE: Ascerta Firm (08714729861720) The delivery system is not designed for use with power injection systems. o. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. 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. 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. BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. Disposable devices intended to assist implantation may be included. All rights reserved. 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. Premarket Submission Number Not Available/Not Released. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. 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. endstream endobj startxref 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. EMERGE PTCA Dilatation Catheter - Boston Scientific Data on file, BD Peripheral Intervention, Tempe, AZ. The safety and effectiveness of this device for use in the arterial system have not been established. A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. 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. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! 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. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. 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. Data on file. 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. All stents should be deployed in accordance with the manufacturers indications and instructions for use. AccessGUDID - DEVICE: Tria Soft (08714729959915) 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. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. Stents were evaluated at the 36-month follow-up for fracture analysis. 2023 Boston Medical Center. Testing completed by Boston Scientific Corporation. Data on file. By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. 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. 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. 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. Data on file. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. 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. CAUTION: The law restricts these devices to sale by or on the order of a physician. THE List - MRI Safety For both in-person and virtual visits, BMC is here to ensure you have everything you need to make your visit a success. Epub 2021 Sep 20. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. $ fG1012p("3| 2 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. Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. 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. 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. 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. 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). TLR is defined as the first revascularization procedure in the target vessel(s) following the index procedure, as determined by an Independent Core Lab. Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. 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. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 Disposable devices intended to assist implantation may be included. Several of these demonstrated magnetic field interactions. Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . The C-Code used forNC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). hbbd```b``>"tH/ MRI also has one exam that uses oral contrast to help visualize the digestive track. Shellock R & D Services, Inc. email: [email protected]. Bench test results may not necessarily be indicative of clinical performance. Missing x-ray analyses were recorded as protocol deviations. The long-term outcomes following repeat dilatation of endothelialized stents are unknown. This site is Exclusively Sponsored by BRACCO. Find out who we are, explore careers at the company, and view our financial performance. 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 SYNERGY. THE List - MRI Safety Find products, medical specialty information, and education opportunities. 2785 0 obj <> endobj BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. During system flushing, observe that saline exits at the catheter tip. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. MRI exams require people to lie still for the entire length of the study. Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. All rights reserved. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. endstream endobj 2789 0 obj <>stream Data on file. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. 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. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q Data on file. Find out who we are, explore careers at the company, and view our financial performance. We are committed to providing the best experience possible for our patients and visitors. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. Several of these demonstrated magnetic field interactions. EMERGE PTCA Dilatation Catheter. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. 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 Data on file. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. Polaris Ultra - BOSTON SCIENTIFIC CORPORATION - In Depth Guide Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. Available in sizes from 1.2 mm to 4.0 mm. %%EOF Reproduced with Permission from the GMDN Agency. 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. Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. 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. through the guidewire lumen, other than those required for normal use. MRI Information for Healthcare Professionals - Boston Scientific 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. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information outflow obstruction. Data on file. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. The Freedom from TLR rate at 36 months was 88.1%. GMDN Names and Definitions: Copyright GMDN Agency 2015. For decades, we have worked together to define the future. Note: Boston Scientific Corporation is not responsible for correct use of codes on . Coils, Filters, Stents, and Grafts More. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Never use air or any gaseous medium to inflate the balloon. Coronary artery spasm in the absence of a significant stenosis. Testing completed by Boston Scientific Corporation. The device is intended for use by physicians who have received appropriate training. hUmo0+}B~Dx&~XQT,%DN nU|w{p 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.
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