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.
Un equipo de Holanda recomendó utilizar la reparación endovascular (REVA) para tratar la rotura de los aneurismas de la aorta abdominal (RAAA), en lugar de la cirugía abierta (CA).
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.
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.
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.
Sanitas Hospitales y Nuevos Servicios ha incorporado a su cartera de servicios la escleroterapia con microespuma, el único tratamiento en la actualidad capaz de eliminar varices de cualquier tamaño sin cirugía.
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.
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).
April 14, 2013—At the Society of Interventional Radiology’s 38th Annual Scientific Meeting in New Orleans, Louisiana, a study was presented evaluating the use of drug-eluting stents (DES) in the treatment of critical leg ischemia (CLI) to prevent amputation. In the retrospective study of 107 patients with CLI treated with DES, 90% showed patency at 6 months and 70% at 2 years. All patients in the study who were treated in the early stages of CLI were able to avoid amputation.
A meta-analysis of studies comparing the performance of drug-eluting stents vs. bare metal stents in the treatment of infrapopliteal artery disease has demonstrated favourable one-year results with drug-eluting stents. According to the study, published in the Journal of Endovascular Therapy, patients treated with drug-eluting stents had increased patency rates and freedom from target lesion revascularisation.
The first-in-man experience with a new branched thoracic aortic arch stent graft was performed on 11 April 2013 at the Carolinas HealthCare System’s Sanger Heart & Vascular Institute, Charlotte, USA. The procedure with the Medtronic Valiant Mona device, designed with a branch to preserve the left subclavian artery (LSA), was led by Frank Arko.
The UK National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending rivaroxaban (Xarelto, Bayer Healthcare) as a clinically and cost-effective option for treating pulmonary embolism and preventing recurrent deep vein thrombosis and pulmonary embolism after acute pulmonary embolism in adults. The draft guidance has been issued to consultees for appeal and published on the NICE website for information.
Bard Peripheral Vascular, a subsidiary of C R Bard, announced on 3 April 2013 the launch of the Love Your Limbs awareness campaign, a new Bard-sponsored initiative intended to raise awareness of critical limb ischaemia, its precursor, peripheral artery disease, and limb amputation awareness and prevention.
Biotronik has announced positive 12-month results from the BIOLUX P-I study, demonstrating excellent clinical outcomes for the Biotronik Passeo-18 Lux paclitaxel-eluting balloon. BIOLUX P-I is a randomised controlled study investigating the safety and performance of the Passeo-18 Lux drug-eluting device (n=30), versus an uncoated Passeo-18 angioplasty catheter (n=30), for the treatment of lesions in the femoropopliteal segment up to 200mm in length. Patients were enrolled at five centres in Germany and Austria.
Drug-eluting stents can keep clogged leg arteries open, preventing amputation of the leg, suggests research being presented at the Society of Interventional Radiology’s 38th Annual Scientific Meeting in New Orleans, USA (13–18 April 2013).
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