Medtronic is expanding its portfolio of products for endovascular aortic repair in the United States with two new medical devices: the company recently received approval from the FDA for the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and the FDA’s 510(k) clearance for the Sentrant Introducer Sheath; both devices will be on exhibit at the Medtronic booth during the Society for Vascular Surgery’s Vascular Annual Meeting, which runs 30 May–2 June in San Francisco, USA.
Biosensors has entered into a licensing agreement with Eurocor for its drug-eluting balloon technology and related intellectual property rights in relation to the treatment of both coronary and peripheral artery disease. As a first step in this process, Biosensors will market and sell, under its own brand, drug-eluting balloons manufactured by Eurocor.
La aspirina parece ser tan buena como los anticoagulantes más caros y potentes en la prevención de la formación de coágulos sanguíneos después de una operación quirúrgica de reemplazo de cadera, según una nueva investigación.
Cardiovascular Systems, Inc. (CSI; St. Paul, MN), announced that the first patient has been enrolled in its postmarket study, LIBERTY 360°. The study is evaluating the acute and long-term clinical and economic outcomes of CSI’s orbital atherectomy system in treating peripheral arterial disease (PAD). Additionally, LIBERTY 360° is the first study of its kind to compare orbital atherectomy to all other PAD treatment options in a difficult-to-treat patient population.
Enrolment in the investigational device exemption study of the Ventana Fenestrated System has been stopped by Endologix. According to the company, after the first 120 procedures, the safety results with the device were good but there have been a high number of renal re-interventions. Endologix plans to integrate its next-generation covered renal stent in the system and conduct additional testing and training to improve future outcomes. The company also reported 22% revenue growth for the first quarter 2013.
Un estudio sugiere que los pacientes con artritis reumática tendrían alto riesgo de padecer tromboembolia venosa (TEV). En los participantes, el riesgo estaba atenuado, pero, aún así, era alto tras considerar los factores de riesgo conocidos, como la enfermedad cardiovascular (ECV), cirugías, internaciones, tratamientos farmacológicos y niveles de reactantes de fase aguda.
Aptus Endosystems, Inc. announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its 28mm Tip Reach Heli-FX™ Guide. A line extension of the original Heli-FX System, the new product enhances treatment of wide neck abdominal aortic aneurysms (AAA). The announcement comes ahead of this week’s Society of Vascular Surgery (SVS) Vascular Annual Meeting in San Francisco where the company will be launching this device as well as the recently approved Heli-FX Thoracic System.
New data on the Endurant abdominal aortic aneurysm (AAA) stent graft system (Medtronic, Inc., Minneapolis, MN) were presented at the Society for Vascular Surgery’s Vascular Annual Meeting being held in San Francisco, California. The new data demonstrate durable clinical performance through 3 years of patient follow-up.
Spectranetics announced on 6 May 2013 FDA approval of its adjunct analysis plan associated with the EXCITE ISR clinical trial, studying the treatment of in-stent restenosis (ISR) in the legs. The goal of the adjunct analysis plan is to demonstrate statistically significant clinical superiority of laser atherectomy plus balloon angioplasty compared with angioplasty alone, prior to full enrolment of the EXCITE ISR study.
Los investigadores han desarrollado una red de las llamadas "nanopartículas" que, en teoría, se podrían inyectar en el cuerpo para liberar insulina y contrarrestar los niveles crecientes de glucemia en los diabéticos. La nano red, que hasta ahora se ha evaluado en ratones, pudo mantener unos niveles normales de glucosa durante más de una semana con una sola inyección. Actualmente, los pacientes tienen que inyectarse insulina varias veces al día para controlar los niveles de glucemia.
Data presented during the Trials and Innovations for Peripheral Interventions Session at EuroPCR (21–24 May 2013, Paris, France) have shown that a stent with a unique three-dimensional helical geometry, the BioMimics 3D (Veryan Medical), has demonstrated safety and promising clinical performance at 12 months in the treatment of patients with peripheral arterial disease undergoing femoropopliteal artery intervention. Data from the MIMICS study appeared to provide the first clinical substantiation for the hypothesis that a stent with 3D geometric curvature will be patency protective through stimulation of swirling flow and elevation of wall shear stress. - See more at: http://www.cxvascular.com/vn-latest-news/vascular-news---latest-news/3d-helical-stent-data-suggest-correlation-between-stented-vessel-curvature-and-primary-patency#sthash.Ggke3Hu9.dpuf
Royal Philips Electronics (NYSE: PHG, AEX: PHIA) today announced that CX50 xMATRIX, the world s first portable ultrasound with Philips industry leading Live 3D TEE, now offers 2-D Intracardiac Echo (ICE) capability. The CX50 xMATRIX with available Live 3D TEE and ICE will be shown in Paris at the EuroPCR, official meeting for the European Association of Percutaneous Cardiovascular Inventions (EAPCI), May 21-24.
April 16, 2013—An interdisciplinary expert consensus document on management of type B aortic dissection was published by Rossella Fattori, MD, et al in the Journal of the American College of Cardiology (JACC; 2013;61:1661–1678). A multidisciplinary panel reviewed available literature to develop treatment algorithms using a consensus method. The panel advised that this consensus document proposes strategies based on nonrobust evidence for management of type B aortic dissection, and that literature results were largely heterogeneous and should be interpreted cautiously.
En la prevención del accidente cerebrovascular (ACV) en los pacientes con fibrilación auricular (FA), el fármaco apixaban (Eliquis) se compara favorablemente con la warfarina en distintos Rangos Internacionales Normatizados (RIN), como lo revela un análisis secundario del ensayo clínico ARISTOTLE. Inicialmente, el ensayo había demostrado que 5 mg de apixaban dos veces por día reducía el riesgo de ACV, embolia sistémica, hemorragia y morir versus la warfarina.
Vascular specialists at Carolinas HealthCare System in Charlotte, USA, and the Cleveland Clinic, Cleveland, USA, recently performed the initial implants of a novel stent graft system from Medtronic as part of a US Food and Drug Administration (FDA) initiative designed to encourage more early-stage clinical research on new medical devices in USA, according to a release. These implants were among the first to be performed under this FDA early feasibility pilot programme, which includes a total of nine medical devices from different companies.
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