Volcano has announced it has received FDA clearance and the CE mark to market its new Visions PV .035 Digital IVUS Catheter in both the USA and Europe. The new intravascular ultrasound catheter is designed to image large vessels and facilitate the use of less iodinated contrast in endovascular procedures.
Medtronic announced the US and international launches of the Amphirion Plus Percutaneous Transluminal Angioplasty (PTA) Catheter for the interventional treatment of atherosclerotically narrowed leg arteries below the knee.
October 9, 2012—Many options exist to treat patients with intermittent claudication due to peripheral artery disease of the femoral and/or popliteal vessel(s). Michael R. Jaff, DO, presented a study on the health economics of peripheral drug-eluting balloons and other therapies during a Late-Breaking Trials session at the VIVA 2012: Vascular InterVentional Advances meeting in Las Vegas.
October 10, 2012—The PFAST-CTOs (Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions) trial was a prospective, multicenter, single-arm study intended to demonstrate the ability of the Viance crossing catheter (Covidien, Mansfield, MA) and Enteer reentry system (Covidien) to facilitate safe and effective intraluminal placement of a guidewire beyond challenging peripheral chronic total occlusions (CTOs) without a significant increase in adverse events as compared to the literature. William A. Gray, MD, presented the final results of PFAST-CTO at VIVA 2012: Vascular InterVentional Advances in Las Vegas during a Late-Breaking Trials Session.
October 10, 2012—Michael R. Jaff, DO, presented 1-year results from the STROLL study during a Late-Breaking Trials session at the VIVA 2012: Vascular InterVentional Advances meeting in Las Vegas. STROLL assessed the safety and efficacy of the SMART nitinol self-expandable stent system (Cordis Corporation, Bridgewater, NJ) in treating patients with obstructive superficial femoral artery (SFA) disease. In the United States, the SMART stent is not approved for use in the SFA, and a premarket approval application is currently under review with the US Food and Drug Administration.
The US Food and Drug Administration (FDA) has given TriVascular premarket approval (PMA) for its Ovation Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA).
On 5 October, Medtronic announced that patient enrolment in IN.PACT DEEP, a landmark study of its In.Pact Amphirion drug-eluting balloon, has been completed, with initial results expected in 2013.
A gene that contributes to cancer and cardiovascular development may be the cause of swelling in the most common type of aortic aneurysm, and could be the key to treatment.
On 3 October, the UK’ National Institute for Health and Clinical Excellence (NICE) opened a consultation on a new draft quality standard for the management of venous thromboembolic (VTE) diseases. The draft quality standard describes markers of high-quality, cost-effective care that, when delivered collectively, should contribute to improving the effectiveness, safety and experience of care for people with venous thromboembolic diseases.
Early results from ACST-2 suggest that modern carotid artery stenting and carotid endarterectomy have a low serious morbidity and mortality, according to early results of the Asymptomatic Carotid Surgery Trial 2 (ACST-2).
The US Food and Drug Administration (FDA) has given approval to Bolton Medical for its Relay Thoracic Stent-Graft with Plus Delivery System which is designed to be used in the treatment of thoracic aortic aneurysms and penetrating atherosclerotic ulcers.
Boston Scientific has launched in European countries the Promus Element Plus BTK (below the knee) Everolimus-Eluting Stent System for the treatment of certain severe peripheral artery lesions. The drug-eluting stent has CE mark approval for both monorail and over-the-wire versions and will be available immediately.
The US Food and Drug Administration (FDA) has given 510(k) clearance to Aptus Endosystems for its thoracic-length HeliFX Aortic Securement System used in the fixation and sealing of thoracic endovascular aneurysm repair (TEVAR) endografts.
Bayer HealthCare is introducing its Jetstream Atherectomy System for the treatment of peripheral arterial disease in the lower limbs at CIRSE (15–19 September, Lisbon, Portugal).
Covidien announced at CIRSE 2012 (15–19 September, Lisbon, Portugal) the launch of the Viance Crossing Catheter and Enteer Re-entry System for treating chronic total occlusions (CTOs). The devices are now available in the United States, the European Union and other select international markets.
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