Marwan Tabbara, vascular surgeon at the University of Miami Health System, reported using a standard protocol on 855 upper extremity fistulae created over a 10 year period. The findings suggest the use of a standard protocol for creation and management of arteriovenous fistulae can help increase the rate of functional access over the national benchmarks. Additionally, extension/conversions of a malfunctioning fistula to grafts appear to be an excellent method to expedite removal of a tunneled dialysis catheter with concomitant preservation of a fistula.
Gore has announced that the FDA has granted indication for the Gore Viabahn endoprosthesis to treat stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous access grafts.
Simbionix USA Corporation (Cleveland, OH), a provider of medical education and simulation training, announced the release of the Angio Mentor suite, its next-generation simulator platform for endovascular training. The Angio Mentor suite provides clinicians with various platforms on which to practice endovascular skills and full procedures on realistic fluoroscopic images using the same tools used in real procedures. Simbionix introduced the Angio Mentor suite at the VEITH symposium in New York, New York, November 19–22.
Gunnar Tepe (head of Diagnostic and Interventional Radiology, Academic Hospital RoMed, Clinic of Rosenheim, Germany) presented an update on the status of the XXS trial at the VEITHsymposium (19–23 November, New York, USA).
The results from a study looking at interobserver variability in sizing of fenestrated and branched stent grafts have shown a high level of agreement between observer and also some critical discrepancies with may affect clinical results.
Medtronic, Inc. (Minneapolis, MN) announced that the company’s Valiant Mona LSA branch thoracic stent graft system for the treatment of the left subclavian artery (LSA) has demonstrated proof of concept in a first-in-human study. The study, which is being conducted under the US Food and Drug Administration s (FDA) “Innovation Pathway” early feasibility pilot program, enrolled seven patients from the United States. The data were presented at the 2013 VEITH Symposium in New York, New York.
A new study presented at the American Heart Association (AHA) Scientific Sessions in Atlanta and published online in JAMA shows that cell therapy failed to improve walking ability in patients with peripheral arterial disease. Arshed Ali Quyyumi, Emory University School of Medicine, Atlanta, USA, and colleagues studied whether therapy with granulocyte-macrophage colony stimulating factor (GM-CSF), an agent that functions as a white blood cell growth factor, would improve walking performance in patients with symptomatic peripheral artery disease.
Alvimedica Medical Technologies (Catalca, Turkey) announced a merger with CID: Carbostent & Implantable Devices SpA (Saluggia, Italy), which will be joined under the name Alvimedica. The merger provides Alvimedica with three research and development centers in Europe: Catalca, Turkey; Saluggia, Italy; and Assen, the Netherlands. Alvimedica’s global marketing headquarters is in Amsterdam.
Medtronic has decided to recall and stop selling the IN.PACT Amphirion drug-eluting balloon after results from the IN.PACT DEEP clinical study indicated a trend towards a higher rate of major amputation in the drug-eluting balloon arm in patients with below-the-knee disease. The study also showed no benefit with the drug-eluting balloon compared to standard balloon angioplasty in terms of re-intervention and late lumen loss.
Gore has announced the nominees and opening of voting for the 2014 Pioneers in Performance Awards for North America. The announcement was made at the 2014 VEITHsymposium in New York.
Based on forthcoming data from the IN.PACT DEEP clinical study, Medtronic, Inc. (Minneapolis, MN) has recalled and stopped selling its In.Pact Amphirion drug-eluting balloon (DEB) for below-the-knee (BTK) revascularization in patients with critical limb ischemia. The company confirmed that other devices in the In.Pact DEB product family are not subject to this recall. Specifically, the In.Pact Admiral and Pacific DEBs (for use in the superficial femoral artery [SFA]) and the In.Pact Falcon DEB (for use in coronary arteries) remain commercially available in markets where they have been approved.
Ya podemos encontrar lo último en técnicas intervencionistas para tratar el pie diabético, gracias a las enseñanzas del Hospital de Manises a los especialistas vasculares. Un programa de abordaje multidisciplinar que trata esta dolencia, reduciendo así las amputaciones en un 50% y cicatrizando las úlceras en un 85%.
Medtronic, Inc. (Minneapolis, MN) announced that data from the global postmarket ENGAGE registry of the Endurant abdominal aortic aneurysm (AAA) stent graft system for endovascular aneurysm repair (EVAR) demonstrated long-term durability and consistent outcomes at 3 years in a real-world setting. ENGAGE investigator Dittmar Böckler, MD, presented the data at the VEITH symposium, held in New York on November 19–22, 2013.
BTG plc (London, UK) announced that the US Food and Drug Administration (FDA) has approved Varithena (polidocanol endovenous microfoam), which is indicated for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein (GSV) system. The company plans to launch Varithena in the United States during the second quarter of 2014. Formerly known as Varisolve, Varithena is a pharmaceutical-grade, low-nitrogen, polidocanol foam dispensed from a proprietary canister device.
Bolton Medical, Inc. (Sunrise, FL) announced the initiation of its phase II clinical trial in the United States to study the safety and effectiveness of the Treovance abdominal stent graft with Navitel delivery system in patients with infrarenal aortic aneurysms. The phase II study will include 150 patients enrolled at 30 institutions located throughout the United States. Results of this study will support approval of the product in the United States.
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