Treatment of femoropopliteal lesions with the low-dose Lutonix drug-eluting balloon reduces late lumen loss with safety comparable to that of control angioplasty, according to LEVANT I trial results published in the January 2014 issue of JACC: Cardiovascular Interventions.
Gore announced on 27 January 2014 that Himanshu Patel and David Williams, University of Michigan, USA, enrolled the first patient in the Gore TAG Thoracic Branch Endoprosthesis LSA Feasibility Study, a US-based, multicentre feasibility trial. The FDA approved the investigational device exemption (IDE) trial for the Gore TAG Thoracic Branch Endoprosthesis in the treatment of thoracic aortic aneurysms that require coverage of the left subclavian artery (LSA).
Veniti announced on 23 January 2014 that patients in the European Union (EU) were successfully treated for symptomatic venous outflow obstruction of the lower extremities with the Veniti Vici Venous Stent System. These procedures mark the first uses in patients of this novel venous stent from Veniti. More procedures using the Veniti Vici Venous Stent System are scheduled at various locations in the EU, including a live case demonstration at the Leipzig Interventional Course (LINC) on 28 January 2014.
AtheroMed has announced receiving US FDA approval to market the Phoenix Atherectomy System that allows physicians to continuously remove diseased material as it is debulked from patients with peripheral arterial disease, using a low profile atherectomy catheter.
The Ovation registry is evaluating the treatment of abdominal aortic aneurysms in the real-world setting of routine clinical practice. Including the Ovation pre-market clinical trial, over 700 patients have participated in a clinical study with either the Ovation or Ovation Prime stent graft system. The 30-day OVATION post-market study results were presented at the Leipzig Interventional Course (LINC) 2014 on 28 January 2014.
Data from the INNOVATION study presented at the Leipzig Interventional Course (LINC) in Germany continue to demonstrate that the Incraft endovascular aortic repair (EVAR) system from Cordis performs well in patients suffering from abdominal aortic aneurysms two years after treatment. The results were presented on 28 January 2014.
Medtronic has received US FDA approval for use of the Valiant Captivia Thoracic Stent Graft System in the treatment of type B aortic dissections.
Findings from the IN.PACT DEEP clinical trial showed that use of the IN.PACT Amphirion drug-eluting balloon from Medtronic did not result in a differential treatment effect for patients with below-the-knee critical limb ischaemia as compared to use of a standard percutaneous transluminal angioplasty balloon.
Results with the fully self-expanding Stanza bioresorbable scaffold in the superficial femoral artery were presented by Andrew Holden, Auckland, New Zealand, at the VEITHsymposium. He also presented initial results with the new, drug-eluting version of the device. In the presentation, Holden, who is director of Interventional Services at Auckland City Hospital and associate professor of Radiology at Auckland University School of Medicine, noted that the advantages of a bioresorbable scaffold for treatment of superficial femoral artery disease include allowing vessel scaffolding while leaving nothing behind, eliminating chronic vessel irritation due to stenting, not having future interventions encumbered by a permanent stent, and also allowing non-invasive imaging with MR angiography.
Hemodyn 2013—The International Vasculab Conference, chaired by Dr Fausto Passariello, was held on 7–9 November 2013 at Accademia Aeronautica di Pozzuoli, Italy.The event was a success with an outstanding attendance and a very interesting scientific programme with important clinical updates on vascular disease. It provided great learning and a huge opportunity for all delegates. The venue was stunning and there was a real buzz of excitement throughout the event.
For the first time, the Charing Cross Symposium announces an open call for two new abstract and poster sessions which will run in parallel to the main programme: the first aimed at all physicians—senior and junior—and the second aimed at vascular scientists, nurses and technologists.
Hypertension is one of the most prevalent diseases in the world and represents a major cardiovascular risk factor. Sympathetic nerves of the renal arteries play an important role in the development of hypertension, and both afferent and efferent nerves are responsible for stimuli that through different mechanisms result in an increase of sympathetic tone.
On 20 December 2013, Endologix announced that it has received investigational device exemption (IDE) approval from the FDA to begin a pivotal clinical trial to evaluate the safety and effectiveness of the Nellix EndoVascular Aneurysm Sealing System (EVAS) for the endovascular repair of infrarenal abdominal aortic aneurysms.
Boehringer Ingelheim has announced results from the RE-COVER II study evaluating dabigatran compared to warfarin in patients diagnosed with acute deep vein thrombosis and/or pulmonary embolism. In this phase III study, published online in the American Heart Association’s journal Circulation, dabigatran met the primary endpoint of non-inferiority to warfarin for recurrent, symptomatic, objectively-confirmed deep vein thrombosis and/or pulmonary embolism and related deaths during six months of treatment.
Intact Vascular announced on 17 December 2013 the start of enrolment in the TOBA-BTK (Tack optimized balloon angioplasty below the knee) study. This multicentre pilot study will gather data supporting the safety and performance of the Tack-It Endovascular System in patients with critical limb ischaemia due to vascular disease below the knee. A previously enrolled and ongoing clinical trial recruited patients with claudication due to vascular disease for the above-the-knee indication.
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