Data presented during a late breaking clinical trials session at VIVA13 show that a stent with three dimensional helical geometry, BioMimics 3D (Veryan Medical), have demonstrated safety and promising clinical performance at 12 months in the treatment of patients with peripheral arterial disease undergoing femoropopliteal artery intervention.
LEVANT 2, the first clinical trial in the USA to study the use of drug-coated balloons (CR Bard’s Lutonix) for femoropopliteal artery disease, found the procedure is promising for safety and efficacy at six months.
November 6, 2013—Gore & Associates (Flagstaff, AZ) announced that the US Food and Drug Administration (FDA) has approved the 25-cm Gore Viabahn endoprosthesis with heparin bioactive surface for the treatment of symptomatic peripheral arterial disease lesions in the superficial femoral artery (SFA). The new, 25-cm endoprosthesis is designed to cover long-segment lesions in the SFA, potentially reducing the need for multiple devices.
Initial results from its ANCHOR post-market registry evaluating the use of the Heli-FX EndoAnchor System in endovascular aneurysm repair (EVAR) were presented at the VIVA conference in Las Vegas, USA, on 8 October 2013. In the first 250 patients treated with the device in the study, there was a high degree of technical success in both treatment arms—primary group and revision group.
On 31 October, Endologix announced that the first patient was enrolled in the global registry for the Nellix Endovascular Aneurysm Sealing system. The global registry, is one of a number of clinical studies that make up the broader EVAS Forward clinical programme aimed at establishing clinical and economic evidence for endovascular aneurysm sealing (EVAS
The first successful implantations have been carried out in Italy and the United Kingdom, providing endovascular repair to iliac arteries.
An endovascular aortic repair (EVAR) revolution may be here, Andrew Holden, associate professor of Radiology, Auckland City Hospital, Auckland, New Zealand, told delegates at the CIRSE annual meeting (14–18 September, Barcelona, Spain)
David Safley presented the three-year health related quality of life data from the STROLL clinical trial during a late-breaking clinical trials session at the Vascular Interventional Advances (VIVA) 2013 Annual Meeting in Las Vegas, USA.
Vascutek Ltd. (Inchinnan, United Kingdom) announced that it issued a Field Safety Notice initiating a voluntary recall of the Anaconda bifurcate body stent graft system, which is used to treat abdominal aortic aneurysms. The company stated that an issue in the Anaconda system’s release wire in the delivery system is currently being investigated. The issue was discovered through Vascutek’s postmarket surveillance system. More than 17,000 Anaconda stent grafts have been implanted since the system was launched in 2005, noted the company.
The Heart and Vascular Outcomes Research Institute (HVORI, Beverly, MA) announced the launch of the Venous Patient Outcome Registry, which is designed to assess clinical outcomes for various treatments of deep and superficial venous diseases. Uchenna Onyeachom, who previously managed the American Venous Registry, serves as Director of Endovascular Research at HVORI.
Several newly identified markers could provide valuable insight to predict the risk of rupture of abdominal aortic aneurysms, according to new research published in the October issue of The Journal of Nuclear Medicine. Imaging with positron emission tomography/computed tomography (PET/CT) has shown that dense white blood cells in the outermost connective tissue in the vascular wall, increased C-reactive protein and a loss of smooth muscle cells in the middle layer of the vascular wall are all factors that may indicate future aneurysm rupture.
Sapheon announced on 9 September 2013 that it has completed enrolment in the US pivotal study of the VenaSeal Sapheon Closure System. According to the company, 242 patients have been enrolled in the study.
Tactile Medical has launched an ambulatory device for patients with chronic wounds. The ACTitouch Adaptive Compression Therapy system combines two proven therapies—intermittent and sustained compression—in one device to heal venous leg ulcers.
On 24 September, Medtronic announced that the US Food and Drug Administration (FDA) has approved the Complete SE (self-expanding) vascular stent specifically for use in the superficial femoral artery and proximal popliteal artery. - See more at: http://www.cxvascular.com/in-latest-news/interventional-news---latest-news/fda-nod--for-medtronics-complete-se-vascular-stent-for-use-in-lower-extremities#sthash.MpRkOwEP.dpuf
Konstantinos Katsanos, Interventional Radiology, Guy’s and St Thomas’ Hospitals, London, reported on data from a mixed treatment comparison network meta-analysis of randomised controlled trials comparing bare nitinol stents, covered nitinol stents, paclitaxel-eluting stents, sirolimus-eluting stents and paclitaxel-coated balloons with each other and with plain balloon angioplasty in the femoropopliteal artery.
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