FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates (Gore) today introduced GORE® DrySeal Sheath with hydrophilic coating, allowing for easier insertion and removal to and from blood vessels during endovascular repair procedures. The device is designed to increase sheath lubricity with an advantage of minimizing particulation of the hydrophilic coating.
According to results from the PACIFIER (Paclitaxel-coated balloons in femoral indication to defeat restenosis) trial, led by Michael Werk, Martin Luther Hospital, Berlin, Germany, and published in Circulation: Cardiovascular Interventions, percutaneous transluminal angioplasty (PTA) with drug-eluting balloons (DEBs) is associated with significant reductions in late lumen loss and restenosis compared with angioplasty with uncoated balloons in patients with femoropopliteal artery disease.
According to results from the PACIFIER (Paclitaxel-coated balloons in femoral indication to defeat restenosis) trial, led by Michael Werk, Martin Luther Hospital, Berlin, Germany, and published in Circulation: Cardiovascular Interventions, percutaneous transluminal angioplasty (PTA) with drug-eluting balloons (DEBs) is associated with significant reductions in late lumen loss and restenosis compared with angioplasty with uncoated balloons in patients with femoropopliteal artery disease.
According to a quality of life sub-analysis from the DREAM trial, endovascular aneurysm repair (EVAR) shows a moderate benefit of quality of life up to six weeks after the procedure but open repair wins in the long run. The results were presented by Jan D Blankensteijn, associate professor of surgery, VU Medical Center, Amsterdam, The Netherlands, at the VEITHsymposium (14–18 November, New York, USA).
By Roberto Sacilotto. In the past decade, the most significant change in the treatment of critical limb ischaemia has been the shift from bypass surgery to less invasive endovascular procedures as first choice revascularisation interventions. In the initial reports of percutaneous transluminal angioplasty use for critical limb ischaemia patients, relatively poor rates of secondary patency were frequently observed but with satisfactory values of limb salvage. Recent investigations for infrapopliteal angioplasty have shown increasingly better results in patency and limb salvage.
The Fenestrated Anaconda custom AAA Stent Graft System (Vascutek) achieves high procedural success in short-necked abdominal and pararenal aortic aneurysms, according to results from UK and Dutch experiences presented at the VEITHsymposium in November.
Biotronik has announced the twelve-month results from the prospective, multicentre, single-arm 4EVER study, which demonstrates the efficacy and safety of the Pulsar self-expanding stent system in 120 superficial femoral artery (SFA) patients.
On 14 November, Biotronik announced the first US implant of their Pulsar-18 self expanding stent in the BIOFLEX-I investigational device exemption clinical trial. Carlos Mena, Yale University Medical Center, USA, performed the procedure.
Two-year clinical data presented in two studies―the US investigational device exemption (IDE) study and the international ENGAGE registry―have shown positive results for the Endurant AAA stent graft system (Medtronic) used in abdominal aortic aneurysm repair. Data were presented by Dittmar Bockler, ENGAGE investigator, at the VEITHsymposium (14–18 November, New York, USA).
The US Food and Drug Administration (FDA) has granted approval to Medtronic to market its Valiant Captivia stent graft system for the endovascular repair of isolated lesions (excluding dissections) of the descending segment of the thoracic aorta. This expanded indication includes the treatment of transections, commonly known as blunt traumatic aortic injuries, as an alternative to invasive surgery.
Gore has received the CE mark for the new large diameter 35mm trunk-ipsilateral leg and 36mm aortic extender components of the Gore Excluder AAA Endoprosthesis. The new components provide physicians with a new endovascular option to treat abdominal aortic aneurysms in patients with an infrarenal aortic inner neck diameter range of 30 to 32mm, which expands the overall treatment range to 19–32mm.
Gore has announced the commercial availability of its new 10cm configuration of the Gore Hybrid Vascular Graft. The new configuration allows for access to deeper vessels, which expands the treatable patient population.
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There is still room for improvement in trying to solve ineligibility due to access, navigational challenges and placement inaccuracies in EVAR, Gioachino Coppi, University of Modena and Reggio Emilia, Italy, stated at the VEITHsymposium (14–18 November 2012, New York, USA). Coppi presented one-year results with the new customisable, ultra-low profile Incraft abdominal aortic aneurysm stent graft system, designed to address these issues. Coppi said the one-year data were “encouraging”.
Endotach LLC sues Medtronic, alleging infringement of a pair of patents covering stent graft technology by the medical device company s Talent, Valiant and Endurant devices.
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