Raffaele Piccolo (Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy) and others report in Thrombosis and Haemostasis that, according to the results of a new meta-analysis, bivalirudin (Angiomax, The Medicines Company) significantly increases the risk of early stent thrombosis (specifically, acute stent thrombosis) in patients undergoing percutaneous coronary intervention (PCI) compared with other antithrombotic therapies. However, the drug is also associated with a significant decrease in major bleeding and does not increase the risk of death or myocardial infarction.
Biotronik has announced the completion of enrolment in the BIOSOLVE-II trial—a clinical study investigating the safety and performance of DREAMS (Drug eluting absorbable metal scaffold).
CeloNova BioSciences has completed patient enrolment in the global, multicentre IDE trial for its Cobra PzF stent. Completed enrolment was ahead of schedule and supports submission for FDA approval of the novel Cobra PzF stent with its advanced, nano-thin coating of Polyzene-F polymer.
According to a retrospective study in EuroIntervention, drug-coated balloons are associated with similar angiographic and clinical outcomes to drug-eluting stents (including both first- and second-generation stents) for the management of stent restenosis. The study also showed that drug-coated balloons may offer more favourable outcomes than drug-eluting stents for non-focal type lesions in this setting.
JW Medical Systems Limited has announced completion of patient enrolment in CREDIT II, the first randomised controlled trial involving the Excel II coronary stent. Excel II is the latest generation in the Excel family of biodegradable polymer drug-eluting stents. The Excel II stent features an abluminal coating of sirolimus combined with an optimised PLA biodegradable polymer, and is deployed from a new delivery system.
This pause in enrolment is in accordance with the study protocol where in the event that more than three of the first twenty subjects pass away for any reason, including non-device related deaths, the company will work with the FDA to discuss a plan to resume enrolment.
Medtronic has announced the start of its Resolute Onyx Clinical Program in the United States, which will evaluate the Resolute Onyx drug-eluting stent in patients with coronary artery disease. Included in the first phase of the study are patients with small vessels that would require a 2mm stent, which until now, often were untreatable with a drug-eluting stent. Core sizes of the stent will be studied separately.
A detailed report of the first successful case of a direct transcatheter tricuspid repair (TTVR) for severe tricuspid regurgitation has been published by J Schofer of the Medicare Center and Department for Percutaneous Interventions of Structural Heart Disease, Albertinen Heart Center, Hamburg, Germany, in the current issue of the Journal of the American College of Cardiology. The Mitralign system is currently being evaluated in clinical trials for an indication in functional mitral regurgitation. The device is not approved for sale or distribution in the EU or USA.
Infraredx will premiere its new Advanced TVC Imaging System and the Muller NIRS-IVUS Catheter featuring Extended Bandwidth IVUS technology at the American College of Cardiology (ACC)’s 2015 Annual Scientific Meeting (14–16 March, San Diego, USA) at booth #1215.
Michael Weber has been appointed to Ablative Solutions’ Scientific Advisory Board. Weber is an expert in the areas of hypertension and preventive cardiology, and is currently a professor of medicine at SUNY Downstate College of Medicine in, New York City, USA. He is also the editor-in-chief of The Journal of Clinical Hypertension. Weber was one of the founders of The American Society of Hypertension and has previously served as its president.
Sorin has announced the first successful implants of the Equilia system in the Vanguard (Vagal nerve stimulation safeguarding heart failure patients) clinical study. The system is intended to treat heart failure by stimulating the vagus nerve.
Biosensors has announced completion of patient enrolment in LEADERS Free Japan, a trial focusing on BioFreedom, the company’s novel polymer and carrier-free drug-coated stent.
Medtronic plc has launched the Euphora semicompliant balloon dilatation catheter in countries that recognise the CE mark. The first patient case with the Euphora was recently performed by Richard Edwards, consultant cardiologist at the Freeman Hospital in Newcastle, UK. The device is not available in the USA.
New data on Stentys’ Self-Apposing stent in treating the left main coronary artery has been published in the peer-reviewed journal Catheterization and Cardiovascular Interventions. The authors concluded that the Stentys drug-eluting stent offers a valid treatment alternative for this indication.
Asahi Intecc and Svelte Medical Systems have announced that Asahi Intecc USA, a subsidiary company of Asahi Intecc, and Svelte have executed formal agreements relating to the manufacture and co-branding of the Svelte drug-eluting coronary stent fixed wire integrated delivery system. The collaboration will feature Asahi’s latest Actone wire technology in the design, development and supply of core wire and coil assemblies for the Svelte system.
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