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NOTICIAS


29 mayo 2013

FDA approves adjunct analysis plan for laser atherectomy trial

Vascular News

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.

29 mayo 2013

La nano medicina podría algún día liberar a los diabéticos de tener que inyectarse a diario

Health Day News

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.

22 mayo 2013

3D helical stent data suggest correlation between stented vessel curvature and primary patency

Vascular News

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

21 mayo 2013

Philips CX50 xMATRIX now offers world-class interventional and diagnostic features on single portable system

Healthcare Sales & Marketing Network

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.

16 abril 2013

Interdisciplinary Expert Consensus Document on Management of Type B Aortic Dissection Published

Endovascular Today

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.

16 mayo 2013

Apixaban se compara favorablemente con la warfarina en distintos niveles terapéuticos

Reuters Health

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.

07 mayo 2013

Medtronic reports initial implants of novel stent graft for aortic aneurysms involving branch vessel

Vascular News

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.

06 mayo 2013

Study Examines Associations of MRI-Measured SFA Occlusions With Functional Performance and Collateral Vessel Number in PAD

Endovascular Today

May 6, 2013—The Journal of the American College of Cardiology (JACC): Cardiovascular Imaging announced the publication online ahead of print of a study by Mary M. McDermott, MD, et al of the associations of magnetic resonance imaging (MRI)-measured superficial femoral artery (SFA) occlusions with functional performance, leg symptoms, and collateral vessel number in peripheral artery disease (PAD). The investigators studied associations of collateral vessel number with functional performance in PAD.

30 abril 2013

FDA Approves CSL Behring’s Kcentra for Urgent Warfarin Reversal in Patients With Acute Major Bleeding

Endovascular Today

April 30, 2013—CSL Behring (King of Prussia, PA) announced that the US Food and Drug Administration (FDA) approved the company’s Kcentra, a nonactivated, 4-factor, human prothrombin complex concentrate (PCC) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (eg, warfarin) therapy in adult patients with acute major bleeding. In December 2012, the FDA granted Orphan Drug Designation for Kcentra for the treatment of patients needing urgent reversal of vitamin K antagonist therapy due to major bleeding and/or surgical procedures.

19 abril 2013

Stents liberadores de fármacos previenen amputaciones

Reuters Health

El uso de stents liberadores de fármacos para tratar la isquemia crítica de miembros inferiores ayudaría a prevenir la amputación de la pierna afectada, según informó un equipo en la reunión anual de la Sociedad de Radiología Intervencionista (SIR, por su nombre en inglés), en Nueva Orleans.

24 abril 2013

Cook Medical Initiates Voluntary Recall of Zilver PTX Due to Potential for Delivery System Catheter Separation

Endovascular Today

April 24, 2013—Cook Medical (Bloomington, IN) announced that the company has initiated a nationwide/global voluntary recall of its Zilver PTX drug-eluting peripheral stent. The recall is based on its investigation into a small number of complaints that the device s delivery system had separated at the tip of the inner catheter. The company advised that it received 13 complaints of delivery system tip separation with an occurrence rate of 0.043%. Two adverse events, including one death, occurred in cases in which a tip separation was reported.

25 abril 2013

Covidien introduces rapid exchange balloon engineered for use below the knee

Vascular News

Unlike some competitive products, the new RapidCross balloon is not a coronary device retrofitted for use below the knee. Every detail – including the low profile tip, the robust exchange port and the long catheter length – was designed for below-the-knee use. The RapidCross balloon complements Covidien’s NanoCross over-the-wire balloon line for below-the knee solutions.

25 abril 2013

First percutaneous systems for EVAR get FDA approval

Vascular News

Endologix announced on 16 April 2013 that it has received FDA approval of its premarket approval (PMA) supplement for a broadened indication for the company’s 21F profile and smaller EVAR systems to include totally percutaneous endovascular aneurysm repair (PEVAR) based upon the outcomes of the first prospective, multicentre, randomised clinical trial (PEVAR trial).

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