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.
Having a vascular surgeon as part of the transcatheter aortic valve implantation (TAVI) multidisciplinary team has a significant impact on decreasing the number of deaths caused by vascular complications, according to Marc van Sambeek, Catharina Hospital, Eindhoven, The Netherlands. Van Sambeek presented data supporting the participation of a vascular surgeon in the Heart Team at the VEITHsymposium (14–18 November 2012, New York, USA).
BUELACH, Switzerland, November 15, 2012—BIOTRONIK has announced the twelve-month results from the prospective, multicenter, single-arm 4EVER study, which demonstrates the efficacy and safety of BIOTRONIK s Pulsar self-expanding stent system in 120 superficial femoral artery (SFA) patients.
MINNEAPOLIS -- Nov. 13, 2012 -- Consistent with its commitment to clinical excellence, Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has approved the company s 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.
Cook Medical has received FDA approval for the first drug-eluting stent to treat peripheral artery disease in the U.S. The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding metal stent coated with the drug paclitaxel to help prevent recurring narrowing of the artery.
Elx, noviembre de 2012.- El Servicio de Cirugía Vascular del Hospital del Vinalopó ha realizado con éxito una nueva técnica a un paciente de 40 años de edad con hipertensión arterial que, a pesar de ser tratado con múltiples fármacos, continúa presentando cifras de tensión muy elevadas.
Cook Medical has received FDA approval for the first drug-eluting stent to treat peripheral artery disease in the U.S. The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding metal stent coated with the drug paclitaxel to help prevent recurring narrowing of the artery. Drug-eluting stents are currently approved for use in coronary arteries in heart attack patients. Boston Scientific, Abbott Laboratories and Medtronic lead the market, but Cook s is the first of its kind for peripheral arteries.
The US Food and Drug Administration (FDA) has given Avinger approval to market its Ocelot System for the treatment of chronic total occlusions in patients with peripheral arterial disease.
BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Cordis Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved the S.M.A.R.T.® CONTROL® Vascular Stent Systems for use in the superficial femoral artery (SFA) and/or the proximal popliteal artery (PPA). The S.M.A.R.T.® Stent, which has been approved for peripheral indication in international markets since 1999, is now the first stent in the Unites States with both Iliac and SFA indications.
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