CID announced on 18 July 2013 the CE mark of its drug-eluting stent for the treatment of below-the-knee lesions: the Cre8 BTK device. According to CID, the Cre8 BTK polymer-free device embodies the most advanced drug-eluting stent technologies to treat peripheral vascular disease. “Its unique distinctive features—Abluminal Reservoir Technology, Amphilimus formulation and Bio Inducer Surface – make Cre8 the only very effective polymer-free drug-eluting stent available today,” the company claimed.
Vascular specialists at the 2nd Military Medical University-Shanghai Hospital, the 2nd Affiliated Hospital of Harbin Medical University, Jiangsu Province People’s Hospital and Peking University People’s Hospital, China, recently performed the initial implants of a branched stent graft system (Microport).
Endologix, Inc. (Irvine, CA) announced it has completed an initial evaluation of its Ventana clinical trial in the United States that was suspended earlier this year.
Hansen Medical, and Royal Philips have announced that they have reached an important milestone in their long-term collaboration by securing certified compatibility between Hansen Medical’s Magellan Robotic System and Philips’ Allura interventional X-ray systems. According to a company release, article 12 compatibility covers specific technical and service requirements, and means that the Magellan Robotic System is compatible with Philips’ Allura live image-guidance systems when used according to instructions.
Cook Medical (Bloomington, IN) announced that 83.2% of patients with femoropopliteal lesions who were treated with the company’s Zilver PTX self-expanding paclitaxel-coated nitinol stent did not require revascularization at 4 years. This freedom from target lesion revascularization (TLR) rate compares favorably to the 69.4% freedom from TLR rate at 4 years in patients treated with percutaneous transluminal angioplasty (PTA) and a bare metal stent.
The phase III AMPLIFY results, published in New England Journal of Medicine and presented as a late-breaking trial at the Congress of the International Society on Thrombosis and Haemostasis (29 June–4 July 2013, Amsterdam, The Netherlands) showed that apixaban achieved its primary endpoint of noninferiority to the current standard of care.
Aptus Endosystems, a medical device company developing advanced technology for endovascular aneurysm repair (EVAR), has announced that its ANCHOR post-market registry enrolment has surpassed its key milestone of 250 patients.
The results of an investigation to evaluate the predictive value of magnetic resonance imaging (MRI) measures of aortic atherosclerosis for future cardiac events have been published in the June edition of Radiology.
In a trial that included nearly 200 participants with peripheral arterial disease, a home-based exercise intervention with a group-mediated cognitive behavioural intervention component improved walking performance and physical activity in patients with peripheral arterial disease, according to a study in the July issue of JAMA.
Paola De Rango, Vascular and Endovascular Surgery, University of Perugia, Hospital S M Misericordia, Perugia, Italy, presented the five-year outcomes of 104 patients who underwent aortic debranching and thoracic endovascular aortic repair (TEVAR) at the Society for Vascular Surgery (SVS) Vascular Annual Meeting (30 May–1 June 2013, San Francisco, USA).
A third of the deaths and complications after endovascular aneurysm repair (EVAR) occur after discharge, and improving pre-discharge surveillance and post-discharge follow-up may help to identify high-risk patients and further improve 30-day outcomes after EVAR. A study presented at the Vascular Annual Meeting (29 May–1 June 2013, San Francisco, USA) also concluded that post-discharge interventions are needed for complications with high rates of occurrence after the procedure.
New findings from a study carried out by investigators from the University of Texas Medical Branch (UTMB) at Galveston, USA, have identified a lymphocyte that is responsible for the cellular inflammation of the aortic wall that causes aortic dissections.
Bard has announced the enrolment of the first patient in the Lutonix below-the-knee clinical trial at The Cardiac and Vascular Institute in Gainesville, USA. The purpose of this global, multicentre randomised investigational device exemption (IDE) trial is to compare the safety and effectiveness of the Lutonix 014 drug-coated PTA dilatation catheter to a standard angioplasty balloon for the treatment of critical limb ischaemia, according to a press release.
Lombard Medical announced on 21 June 2013 that the Aorflex delivery system has been approved for commercial use in the USA by the FDA. The Aorflex delivery system is the company’s next generation delivery system for its Aorfix stent graft, which was approved by the FDA in February 2013 (along with the previous generation delivery device) for the endovascular repair of abdominal aortic aneurysms.
AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, today announced the completion of enrollment in the Drug-Coated AngioSculpt Scoring Balloon Catheter First-in-Human (FIH) Study (“PATENT-C”). AngioScore anticipates that preliminary data from this study will be available for presentation at the Transcatheter Cardiovascular Therapeutics (TCT) conference to be held this fall in San Francisco.
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