The US Food and Drug Administration (FDA) has approved AstraZenca’s Brilinta (ticagrelor) tablets at a new 60mg dose to be used in patients with a history of heart attack beyond the first year. With this expanded indication, Brilinta is now approved to reduce the rate of cardiovascular death, myocardial infarction and stroke in patients with acute coronary syndrome or a history of myocardial infarction.
Novartis has announced that its investigational heart failure treatment LCZ696 (sacubitril valsartan) has been given a positive scientific opinion under the Medicines and Healthcare products Regulatory Agency (MHRA) Early Access to Medicines Scheme (EAMS) for patients with significant unmet medical need. This allows LCZ696 to be made available to eligible patients before a final European licensing decision is made.
Results from a secondary analysis of the CHAMPION PHOENIX study, which were presented at the 2015 European Society of Cardiology (ESC) meeting (29 August–2 September, London, UK), indicate that the intravenous antiplatelet agent cangrelor (Kengreal, The Medicines Company) is associated with significant reduction in ischaemic events compared with clopidogrel in patients undergoing percutaneous coronary intervention (PCI) with either the femoral or the radial approach.
The first patient has been enrolled in the BIOFLOW-VI clinical study in China. The aim of the study is further demonstrate the safety and efficacy of a hybrid drug-eluting stent (Orsiro, Biotronik) and support Chinese market approval. A press release reports that the first implantation was successfully performed by BIOFLOW-VI coordinating clinical investigator Yuejin Yang at the Fuwai Hospital, Beijing, China.
Results from the ABSORB-Japan study, which were presented at the 2015 European Society of Cardiology meeting (ESC, 29 August–1 September, London, UK), indicate that the bioresorbable vascular scaffold (Absorb, Abbott Vascular) is non-inferior to a everolimus-eluting stent with a permanent polymer (Xience, Abbott Vascular). The results have published online in the European Heart Journal.
HeartWare International has entered into a definitive agreement to acquire Valtech Cardio, a company that specialising in the development of innovative surgical and transcatheter valve repair and replacement devices for the treatment of mitral valve regurgitation (MR) and tricuspid valve regurgitation (TR).
The PLATFORM (Prospective longitudinal trial of FFRCT: Outcome and resource impacts) study, which was presented at the 2015 European Society of Cardiology (ESC) meeting yesterday (1 September) and published in the European Heart Journal, indicates that use of fractional flow reserve computed tomography (FFRCT) is associated with a significant reduction in the number of invasive tests that do not find evidence of obstructive coronary disease.
St Jude Medical has announced that the five-year results from the landmark FAME trial (Fractional flow reserve vs. angiography in multivessel evaluation) have confirmed the long term benefits of fractional flow reserve (FFR) in guiding percutaneous coronary intervention (PCI) over angiography alone. An analysis of the study’s five-year follow-up data confirms that in patients with multivessel coronary artery disease, FFR-guided PCI can contribute to reductions in all-cause mortality, cardiac mortality and an overall use of healthcare resources
In the ALBATROSS study, which was presented at the ESC Congress this morning, adding aldosterone to standard therapy in patients with acute myocardial infarction was not associated with a significant reduction in the primary outcome (which included death, resuscitated cardiac arrest, and significant ventricular arrhythmia). However, there was some indication of a reduction in mortality with aldosterone in patients with ST-segment elevation myocardial infarction (STEMI).
The FDA has approved evolocumab (Repatha, Amgen), which is a new cholesterol-lowering medication that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9)–a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C). The drug is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
Philippe Généreux (Cardiovascular Research Foundation, New York, USA) and others report in the Journal of the American College of Cardiology that data from ADAPT-DES (Assessment of dual antiplatelet therapy with drug-eluting stents) indicate that the risk of all-cause mortality that is associated with post-discharge bleeding after percutaneous coronary intervention (PCI) is 2.6-fold greater than the risk of all-cause mortality that is associated with post-discharge myocardial infarction.
Royal Philips has announced its presence at ESC Congress 2015, where the company is showcasing its latest cardiology solutions, including Heart ModelA.I., EchoNavigator and IntelliSpace Cardiovascular, which “connect people and technology with care protocols to assist diagnosis, guide treatment and enable home care”.
BioControl Medical has completed enrolment in its INOVATE-HF (Increase of vagal tone in heart failure) clinical trial evaluating the CardioFit system for the treatment of congestive heart failure. INOVATE-HF has enrolled a total of 725 patients at 86 centres in the USA and Europe, making it the largest prospective, randomised device study to evaluate the treatment of heart failure with vagus nerve stimulation.
The president of the European Society of Cardiology (ESC), Fausto Pinto claims that the society is “very excited” to be holding its annual congress in London (UK) this week (29 August–2 September), stating that the city “has a fantastic reputation for welcoming people from all around the world from international sporting competitions to ground-breaking educational and medical conferences.” He adds that London is a capital of “a pioneer country in cardiovascular research and treatment.”
Medtronic has announced that it has signed a definitive agreement to acquire the company Twelve, which is focused on the development of a transcatheter mitral valve implantation (TMVI) device. A press release reports that the device under development is being designed to treat patients with mitral valve regurgitation in whom standard restorative surgery is not recommended. The majority of these patients are largely under-served with limited treatment options.
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