Data from the US PYTHAGORAS clinical trial show that major adverse events are lower in patients treated with Aorfix than with open repair, and similar in patients with less severe anatomies treated with other EVAR devices. Results from the trial were presented by Mark Fillinger MD, for the PYTHAGORAS Investigators, at the Society for Vascular Surgery Annual Meeting (5–7 June, Boston, USA).
Somahlution announced on 22 September 2014 that it has received CE mark approval for DuraGraft, the first-in-class endothelial damage inhibitor (EDI) that uniquely protects vascular endothelium function and its associated architecture. DuraGraft, used as a vascular conduit solution, is a pivotal step in successful coronary artery bypass graft and peripheral bypass surgeries.
Royal Philips has announced the global launch of the newest addition to its portfolio of surgical imaging systems. The Veradius Unity Mobile Surgical C-arm with Flat Detector will be unveiled at the upcoming European Society of Vascular Surgery Annual Meeting (23–26 September, Stockholm, Sweden).
QT Vascular has announced that it has enrolled the first European patients in the ENDURE trial in Germany. Multiple patients have already been enrolled in this study by Andrew Holden, at Auckland City Hospital, Auckland, New Zealand.
TriVascular presented three-year primary safety and performance metrics from the Ovation Pivotal Trial at the 2014 Joint Annual Meeting of the New England Vascular Society and Eastern Vascular Society (11–14 September 2014, Boston, USA).
Data from the EXCITE ISR clinical trial presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference show that laser atherectomy (Turbo-Tandem, Spectranetics) used with balloon angioplasty delivers superior results when compared to angioplasty alone in both safety and efficacy.
CSL Behring has announced that the last patient has been treated as part of the REPLACE (Randomized evaluation of fibrinogen versus placebo in complex cardiovascular surgery) phase III clinical trial. REPLACE is the first randomised, double blinded, placebo-controlled, multicentre study in a large population of patients evaluating fibrinogen concentrate (Human) (FCH) in controlling bleeding during aortic aneurysm surgery.
Cardiovascular Systems unveiled new data about the treatment of arterial calcification at the 2014 Transcatheter Cardiovascular Therapeutics conference (TCT; 13–17 September, Washington DC, USA). Arterial calcium is a common occurrence for the millions of patients suffering from peripheral artery disease and it can lead to significant complications. Calcified plaque is estimated to be present in approximately 65 percent of the population treated annually for peripheral artery disease.
Six-month results from the randomised clinical trial, BIOLUX P-II, that compared the Passeo-18 Lux paclitaxel-releasing balloon (Biotronik) vs. plain old balloon angioplasty with the uncoated Passeo-18 balloon for the treatment of infrapopliteal artery lesions, have shown that treatment with the drug-eluting balloon results in significant clinical improvement of Rutherford 5 patients.
A retrospective analysis from Wales, UK, finds that although there are no randomised controlled trials comparing open and endovascular repair of mycotic aortic aneurysms in the thorax and abdomen, endovascular aneurysm repair (EVAR) is a favourable treatment.
Bristol-Myers Squibb and Pfizer have announced results of a pre-specified secondary analysis of the Eliquis phase 3 AMPLIFY-EXT trial (Apixaban after the initial management of pulmonary embolism and deep vein thrombosis with first-line therapy-extended treatment). The analysis evaluated clinical and demographic predictors of all-cause hospitalisation in patients with venous thromboembolism, which includes deep vein thrombosis and pulmonary embolism. Results from this analysis demonstrated that during the 12-month extended treatment of venous thromboembolism, Eliquis significantly reduced the risk of hospitalisation versus placebo. This effect was independent of other variables including renal function, the only other significant predictor of hospitalisation in the AMPLIFY-EXT population. These data were presented during an oral session in Barcelona, Spain, at the ESC Congress 2014
Directional atherectomy is safe and effective as a frontline therapy for the treatment of peripheral arterial disease, according to a multicentre study published online in the Journal of American College of Cardiology: Cardiovascular Interventions
BTG International has announced that the first varicose vein patient has been treated with Varithena (polidocanol injectable foam), the only FDA-approved foam for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous veins system both above and below the knee
The Spectranetics Corporation has announced receiving US FDA 510(k) clearance of their peripheral atherectomy products, Turbo-Tandem and Turbo Elite, for the treatment of in-stent restenosis
The Spectranetics Corporation has announced receiving US FDA 510(k) clearance of their peripheral atherectomy products, Turbo-Tandem and Turbo Elite, for the treatment of in-stent restenosis
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