To obtain copies images, please call the film library at 617.414.5882. 44, no. PDF Resolute Onyx Zotarolimus-Eluting Coronary Stent System Rapid Exchange Data on file. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. THE List - MRI Safety The device is typically intended for long-term, but not permanent, implantation. PDF Summary of Safety and Effectivness (SSED)Template Then the patient is brought out of the scanner. 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. 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. Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. 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. 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. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. 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. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. PDF VICI VENOUS STENT System Instructions for Use - Food and Drug Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. The stent is not designed for repositioning or recapturing. 98 subjects x-rays were analyzed and no stent fractures were reported. Find products, medical specialty information, and education opportunities. The Venovo Venous Stent System is supplied sterile and is intended for single use only. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. Find products, medical specialty information, and education opportunities. One Boston Medical Center Place 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. Never use air or any gaseous medium to inflate the balloon.

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