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Paul E Davis, John Phillips, Raghu Kolluri
BACKGROUND: We performed a retrospective review of treatment effects with FDA-approved Polidocanol endovenous microfoam (PEM, Varithena® 1%) on venous symptomology in ten (N=10) C3-C6 patients with chronic venous insufficiency (CVI) and concomitant complex disease/pathology that limited the use of endothermal ablation (ETA). METHODS: Pathology included: risk of bruising or bleeding, severe lipodermatosclerosis (LDS), Hydradenitis Suppurativa, chronic fibrosis of the vein from prior superficial thrombosis, risk for nerve injury and failed prior ETA...
May 14, 2018: Annals of Vascular Surgery
Phoebe Star, David E Connor, Kurosh Parsi
Scope Varithena® is a recently approved commercially available drug/delivery unit that produces foam using 1% polidocanol for the management of varicose veins. The purpose of this review is to examine the benefits of foam sclerotherapy, features of the ideal foam sclerosant and the strengths and limitations of Varithena® in the context of current foam sclerotherapy practices. Method Electronic databases including PubMed, Medline (Ovid) SP as well as trial registries and product information sheets were searched using the keywords, 'Varithena', 'Varisolve', 'polidocanol endovenous microfoam', 'polidocanol' and/or 'foam sclerotherapy/sclerosant'...
April 2018: Phlebology
Kathleen Gibson, Lowell Kabnick
Objectives A randomized, placebo-controlled, multicenter study was conducted to evaluate the safety and efficacy of polidocanol endovenous microfoam (1%, Varithena® [polidocanol injectable foam], BTG International Ltd.). Methods Patients (n = 77) with symptomatic, visible varicose veins were randomized to treatment with either Varithena 1% or placebo. Results Varithena provided greater mean changes from Baseline in patient-reported assessments of symptoms (e.g., heaviness, achiness, swelling, throbbing, itching [HASTI®] score 30...
April 2017: Phlebology
Kenneth L Todd, David I Wright
OBJECTIVE: The objectives of this study were to assess the durability of response to treatment with polidocanol endovenous microfoam (Varithena; Provensis Ltd, a BTG International group company) and to assess the long-term safety of the study patients. METHODS: This report presents efficacy and safety data from the day after visit 5/week 8 (the primary end point of the study) through the 1-year study visit. As the approved dose concentration is 1%, this analysis focuses on those patients who were randomized to polidocanol endovenous microfoam 1% at study visit 2...
July 2015: Journal of Vascular Surgery. Venous and Lymphatic Disorders
Michael Vasquez, Antonios P Gasparis
Objectives * Varithena 017 Investigator Group: Michael Vasquez, MD, Venous Institute of Buffalo, Amherst, NY; Antonios Gasparis, MD, Stony Brook University Medical Center, Stony Brook, NY; Kathleen Gibson, MD, Lake Washington Vascular, Bellevue, WA; James Theodore King, MD, Vein Clinics of America, Oakbrook Terrace, IL; Nick Morrison, MD, Morrison Vein Institute, Scottsdale, AZ; Girish Munavalli, MD, Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC; Eulogio J. Sanchez, MD, Batey Cardiovascular Center, Bradenton, FL...
May 2017: Phlebology
Dario Carugo, Dyan N Ankrett, Vincent O'Byrne, David D I Wright, Andrew L Lewis, Martyn Hill, Xunli Zhang
We have recently reported on the development of a biomimetic vein model to measure the performance of sclerosing foams. In this study we employed the model to compare the commercially-available Varithena(®) (polidocanol injectable foam) 1% varicose vein treatment (referred to as polidocanol endovenous microfoam, or PEM) with physician compounded foams (PCFs) made using different foam generation methods (Double Syringe System and Tessari methods) and different foam formulations [liquid to gas ratios of 1:3 or 1:7; gas mixtures composed of 100% CO2, various CO2:O2 mixtures and room air (RA)]...
November 2015: Journal of Materials Science. Materials in Medicine
J T King, M O'Byrne, M Vasquez, D Wright
OBJECTIVE: This multicenter, parallel group study was designed to determine if a single administration of ≤15 mL of pharmaceutical-grade polidocanol endovenous microfoam (PEM, now approved in the United States as Varithena [polidocanol injectable foam], BTG International Ltd.) could alleviate symptoms and improve appearance of varicose veins in a typical population of patients with moderate to very severe symptoms of superficial venous incompetence and visible varicosities of the great saphenous vein (GSV) system...
December 2015: European Journal of Vascular and Endovascular Surgery
(no author information available yet)
No abstract text is available yet for this article.
August 3, 2015: Medical Letter on Drugs and Therapeutics
Dario Carugo, Dyan N Ankrett, Xuefeng Zhao, Xunli Zhang, Martyn Hill, Vincent O'Byrne, James Hoad, Mehreen Arif, David D I Wright, Andrew L Lewis
OBJECTIVE: To compare foam bubble size and bubble size distribution, stability, and degradation rate of commercially available polidocanol endovenous microfoam (Varithena®) and physician-compounded foams using a number of laboratory tests. METHODS: Foam properties of polidocanol endovenous microfoam and physician-compounded foams were measured and compared using a glass-plate method and a Sympatec QICPIC image analysis method to measure bubble size and bubble size distribution, Turbiscan™ LAB for foam half time and drainage and a novel biomimetic vein model to measure foam stability...
May 2016: Phlebology
Jean-Jérôme Guex
The constant evolution of endo-venous ablative techniques for varicose veins arises from the need for: better patient's comfort, reduced incidence of side effects, better results at short-, mid- and long-term follow-up, as well as reduction of operating time and technical simplicity. All these goals have been aimed at but so far no new technology has been able to achieve them all or to demonstrate it, furthermore the increase of price must be compensated by a considerable improvement of results and a serious reduction of side effects to be incrementally cost effective...
May 2014: Phlebology
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