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
Cyanoacrylate adhesive embolization using the VenaSeal Sapheon Closure System (Venaseal) of the incompetent great saphenous veins offers several advantages over endothermal ablation including not requiring tumescent anasthaesia and use of compression stockings after the intervention. Endothermal ablation can also cause paresthesia in 5–10% of patients
The third paper in the series, published online on 18 July 2014 in Catheterization & Cardiovascular Interventions, outlines recommendations for treating infrapopliteal, or arterial disease below the knee
Two-year data from a prospective, multicentre study suggest that endovascular therapy with stenting may be considered the preferred first-line treatment option for aortoiliac lesions, irrespectively of TASC lesion category
Biotronik has announced that the first patient has been enrolled in the investigator-initiated BIOLUX 4EVER trial. Given the positive results from each of the previous drug-eluting balloon and self-expanding stent trials, investigators were interested in exploring the combined use of the Pulsar-18 self-expanding stent and Passeo-18 Lux drug-eluting balloon to see if the outcome could be improved further. BIOLUX 4EVER will follow the study design of the previously completed, investigator-initiated 4EVER trial, which examined the efficacy of the Pulsar-18 self-expanding stent in the treatment of superficial femoral artery lesions, but this time adding the Passeo-18 Lux drug-eluting balloon to the treatment. The study will enrol 120 patients treated with both products, with the primary endpoint of primary patency at 12 months
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