Looking at images of their own calcified coronary arteries may be a wake-up call for patients with newly diagnosed coronary artery disease to change their lifestyles, reveals new research. The study was presented at EuroHeartCare 2015 (14–15 June, Dubrovnik, Croatia) by Rikke Elmose Mols, a nurse and PhD student in the Department of Cardiology at Aarhus University Hospital-Skejby in Denmark.
Yanai Ben-Gal (Department of Cardiothoracic Surgery, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel) and others report in Circulation: Coronary Interventions that the one-year rates of myocardial infarction and death in diabetic patients with acute coronary syndromes and multivessel disease who have undergone percutaneous coronary intervention (PCI) are comparable to those of patients in this subgroup who have undergone coronary artery bypass grafting (CABG). However, the authors note that PCI is associated with a greater need for repeat revascularisation.
Natec Medical has received 510k approval from US Food and Drug Administration (FDA) for its Filao NC PTCA balloon catheter, Natec’s third device to obtain FDA approval.
Boehringer Ingelheim has announced that the first US patients have been enrolled in its international clinical trial—RE-DUAL PCI, which is evaluating the efficacy and safety of dabigatran in patients with non-valvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI). Patients have also been enrolled in RE-CIRCUIT, which is looking at the safety of using the drug in patients who are undergoing a first ablation procedure.
Essential Medical has successfully commenced EU clinical studies using its Manta large bore vascular closure device, a vascular closure device designed to seal both 14F and 18F large bore femoral punctures.
Results from the 9th Annual Survey on Observational Research conducted by Continuum Clinical suggest that the pharmaceutical, biotech, and medical device industries are aware of the benefits of observational research in better understanding the real world value of their products. However, they also show that there is continued need to improve the design and implementation of the studies.
A new clinical trial to test how a high dose of stem cells delivered via a method called retrograde coronary sinus infusion affects end stage heart failure patients is showing promising results. The method involves delivering the cells backwards through the heart through the coronary sinus.
Six hot line sessions at European Society of Cardiology (ESC) Congress (London, UK, 29 August – 2 September) are set to reveal the latest in cardiovascular disease research across a range of conditions and comorbidities. Key topics include atrial fibrillation, pacing, acute myocardial infarction, heart failure, hypertension, diabetes mellitus, pharmacology and coronary artery disease.
Micell Technologies has begun enrolling patients in DESSOLVE C: a prospective, single-blind, multicentre, randomised, controlled clinical trial to demonstrate the efficacy and safety of its MiStent SES sirolimus-eluting absorbable polymer coronary stent system.
Sunshine Heart has announced an update on its COUNTER HF US pivotal study for the C-Pulse heart assist system. COUNTER HF is a prospective, randomised, multicentre, controlled study evaluating the safety and efficacy of the C-Pulse system for the treatment of NYHA Class III and ambulatory Class IV heart failure.
The global market value for bioabsorbable scaffolds will expand rapidly from US$143.7m in 2014 to just under US$2.1bn by 2021, driven primarily by new product approvals and a paradigm shift in the clinical treatment of vascular diseases towards minimally-invasive procedures, says research and consulting firm GlobalData.
Hospira has obtained US Food and Drug Administration (FDA) approval for the launch of bivalirudin for injection, a generic version of The Medicines Company’s Angiomax. Branded sales of Angiomax in 2014 in the USA were approximately US$500m.
Boston Scientific has received the CE mark and FDA clearance for its Safari2 pre-shaped guidewire—a new and enhanced version of the Safari Guidewire—for introducing and placing interventional devices within the heart (including those used in transcatheter aortic valve implantation; TAVI). The new guidewire is compatible for use with all TAVI devices.
St Jude Medical and Thoratec have announced that the Boards of Directors of both companies have unanimously approved a definitive agreement under which St. Jude Medical will acquire all of the outstanding shares of Thoratec for $63.50 per share in a cash transaction valued at approximately $3.4 billion, net of cash acquired. The transaction is expected to be completed in the fourth quarter of 2015.
HeartFlow has appointed Phil Mui as senior vice president of engineering and product. A former technology executive of Google and Acxiom, Mui will be responsible for guiding the scalable development of HeartFlow’s technology platform, including HeartFlow FFRCT Analysis—a non-invasive technology to offer physicians insight on both the extent of a patient’s arterial blockage, as well as any impact on blood flow.
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