The results of a landmark study published in Circulation indicate that Medtronic’s In.pact Admiral drug-coated balloon (DCB) significantly outperformed standard balloon angioplasty in the treatment of symptomatic peripheral artery disease in the upper leg, specifically, the superficial femoral and proximal popliteal arteries.
biolas has announced the launch of its VariClose vein sealing systems in Europe.
In the United States ruptured abdominal aortic aneurysms account for 15,000 to 30,000 deaths per year. Open surgical repair had been the “gold standard” but was associated with significant morbidity and mortality, and with the advent of elective aortic aneurysm repair with endovascular techniques, this technology was transferred to the treatment of ruptured aneurysms.
Ensuring that patients with peripheral arterial disease get tested and treated with minimally invasive endovascular therapy saves legs and lives, suggests a study in which amputation rates fell by nearly 80% after such a system was implemented.
Three-year follow-up results of patients treated with the Supera stent show that nominal deployment or slight compression of the device delivers the best outcomes in terms of durability, and that severe stent elongation provides the lowest durability through three years. With nominal deployment, the freedom from reintervention rate was 97% at one year and 94% at three years – a “minimal decrease”, according to Lawrence Garcia, who presented the results at the VEITHsymposium (18–22 November, New York, USA).
Lombard Medical has released efficacy and safety data from the two-year follow up of the US PYTHAGORAS pre-marketing approval (PMA) trial of Aorfix, the first and only endovascular stent graft with global approvals for the treatment of patients with aortic neck angulations up to 90 degrees.
Studies presented at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition compare new and standard-of-care treatments for blood clots and further illuminate clot risks in vulnerable populations, such as cancer patients.
Vascular Flow Technologies have presented study results at the 41st Annual VEITH Symposium on Vascular and Endovascular Issues in New York, showing a 30% increase in one-year success for infrainguinal vascular bypass surgery in patients who received a Spiral Flow™ Graft compared to those who received a standard polytetrafluoroethylene (PTFE) graft.
VIVA Physicians, Inc. announced that 4-year results from a prospective, single-arm, multicenter trial conducted at 26 sites in the United States to evaluate the Endurant stent graft system (Medtronic, Inc.) for the treatment of abdominal aortic aneurysms (AAAs) were presented by Edward Woo, MD, during a late-breaking trials session at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada.
VIVA Physicians, Inc. announced that Michael Dake, MD, presented the trial plan and reported preliminary findings from the Gore TAG Thoracic Branch Zone 2 Feasibility Study during a late-breaking trials session at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada.
Hansen Medical, Inc. announced that the company´s Magellan 6-F robotic catheter has received European CE Mark approval for use in the peripheral vasculature. This allows the company to market the Magellan 6-F device in Europe and other countries that recognize the CE Mark. In February 2014, the company announced US Food and Drug Administration 510(k) clearance for the Magellan 6-F robotic catheter, which is commercially available in the United States.
TriVascular Technologies, Inc. announced the commencement of enrollment in the LIFE Study, a multicenter postmarket registry designed to evaluate the Ovation Prime abdominal stent graft system in the treatment of patients with abdominal aortic aneurysms (AAA) using a fast-track protocol for endovascular aneurysm repair (EVAR).
Bolton Medical announced the initiation of the Regeneration clinical trial that will assess the safety and effectiveness of the company’s Relay Pro and Relay NBS Pro thoracic stent graft systems in patients with thoracic aortic pathologies. The study results will support the company´s application for CE Mark approval of the Relay Pro devices.
TriVascular announced that the US Food and Drug Administration has approved its CustomSeal technology for the Ovation Prime endograft system. The customized sealing technology enables faster procedure times, preserves the aortic neck, and provides an optimized seal that is tailored to each patient´s specific anatomy, stated the company.
Julie Brittenden, MD, et al published findings from a randomized trial comparing treatments for varicose veins in the New England Journal of Medicine (2014;371:1218–1227). The background of the study is that ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain, noted the investigators. The study was sponsored by the University of Aberdeen in Scotland, United Kingdom.
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