Biotronik (Lake Oswego, OR) announced 12-month results from the BIOLUX P-I study of the company’s Passeo-18 Lux paclitaxel-releasing balloon. According to the company, BIOLUX P-I is a randomized controlled study investigating the safety and performance of the Passeo-18 Lux device versus the uncoated Passeo-18 percutaneous transluminal angioplasty (PTA) catheter for the treatment of lesions in the femoropopliteal segment up to 200 mm in length. The study enrolled 60 patients, randomized 1:1, at five centers in Germany and Austria.
Ali Khoynezhad, MD, et al have published results from the RESCUE trial in the Journal of Vascular Surgery (2013;57:899-905). RESCUE is a prospective, nonrandomized, multicenter trial using the Medtronic Valiant Captivia stent graft (Medtronic, Inc., Minneapolis, MN) to evaluate the early outcomes of patients undergoing thoracic endovascular aortic repair for blunt thoracic aortic injuries.
Despite evidence supporting the benefit of supervised exercise in intermittent claudication, there is a worldwide scarcity of funds for programmes. Experts were united in their frustration that there is a global lack of funding despite the rhetoric of the need to focus more on prevention.
After listening to the latest data for the Zilver PTX drug-eluting peripheral stent, 81% of delegates at yesterday’s stent data session voted against the motion that “plain old balloon and bare metal stents reign supreme in the superficial femoral artery”.
Cordis launched the Smart Flex Self-Expanding Stent System at CX35. The device belongs to a new generation of self-expandable stents for peripheral indications and, according to the company, is “fully connected and yet flexible.”
The latest updates on devices for abdominal aortic aneurysms, and a discussion on the impact of going low profile so as not to compromise on device performance, formed the mainstay of a session yesterday. There were presentations on the latest results from promising new low profile devices including the Treovance abdominal stent graft (Bolton Medical), which is being launched at CX35
The management of type II endoleak provoked a whole host of opinions among experts at CX35 yesterday. Are type II endoleaks benign, or not? Are “dangerous” type II endoleaks really misdiagnosed type I or type III endoleaks? Do type II endoleaks need treatment (and how), or is leaving them akin to “leaving a baby on a railway line”? Experts taking part in a panel discussion about the management of type II endoleaks following endovascular aneurysm repair (EVAR) did not agree
The incidence of thoracic aortic aneurysms is estimated to be as high as six cases per 100,000 person-years, and replacement of the ascending aorta accounts for the majority of cardiothoracic aortic procedures. Aneurysms and dissections of the ascending aorta are still mainly treated operatively with cardiopulmonary bypass. Ascending aortic aneurysms with normal sinuses and aortic annulus require only replacement of the ascending aorta from the sinotubular ridge to the origin of the innominate artery with a Dacron tube graft.
Medtronic, Inc. (Minneapolis, MN) announced that a new analysis of clinical data on the company’s Endurant abdominal aortic aneurysm (AAA) stent graft system demonstrated consistent performance in treating AAAs across a range of patient anatomies, from relatively straightforward to highly complex. Prof. Hence Verhagen, MD, presented the data at the 35th Charing Cross International Symposium in London, United Kingdom. Prof. Verhagen is Chief of Vascular Surgery at the Erasmus Medical Center in Rotterdam, the Netherlands.
Medtronic, Inc. (Minneapolis, MN) announced that the Sentrant introducer sheath has received CE Mark approval and will soon be launched internationally.
Aptus Endosystems announced on 2 April 2013 that it received CE clearance for its thoracic-length Heli-FX System. Similar to the original Heli-FX system that was cleared for European distribution in May 2011 and designed for treating abdominal aortic aneurysms, the new system consists of a longer delivery device with additional tip configurations to bring the innovative helical EndoAnchor technology to the treatment of thoracic aortic aneurysms.
The first European patients with peripheral arterial disease have been treated with a new ultra low-profile micro-balloon catheter from Cook Medical that allows physicians to treat arterial lesions in the leg below the knee, according to the company.
F Care Systems USA, LLC (North Miami, FL) announced the launch of its EVRF device to provide endovenous radiofrequency treatment of varicose veins. The EVRF machine has received 510(k) clearance from the US Food and Drug Administration (FDA). F Care, headquartered in Aartselaar, Belgium, previously released the EVRF in the United Kingdom and other countries as Veinwave. With F Care s branch in the United States, the company will be offering full upgrades, training, and support to all current Veinwave and EVRF customers.
Paclitaxel-eluting balloons are associated with favourable functional and clinical outcomes at two years in patients with femoropopliteal arterial disease requiring percutaneous revascularisation, according to a study published in the Journal of the American College of Cardiology: Cardiovascular Interventions in March 2013.
Two-year data from an independent, prospective, multicenter registry aimed at assessing outcomes of femoropopliteal angioplasty with a paclitaxel-eluting balloon (PEB) (In.Pact Admiral, Medtronic, Inc., Minneapolis, MN) were recently published by Antonio Micari, MD, et al in the Journal of the American College of Cardiology: Cardiovascular Interventions
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