NaviGate Cardiac Structures has announced that the Gate catheter-guided tricuspid atrioventricular valved stent was implanted through the jugular vein one week ago in a patient with severe tricuspid regurgitation stemming from two failed tricuspid annuloplasty rings that were unable to maintain the patient’s valve competence.
A large nuclear cardiology laboratory has slashed its average radiation dose by 60% in eight years, according to new research presented today at the 2017 International Conference on Nuclear Cardiology and Cardiac Computed Tomography (ICNC) and published in JACC: Cardiovascular Imaging. The study in over 18,000 patients shows dose reductions were achieved despite a large number of obese patients.
A new study indicates that the apparent survival benefit after transcatheter aortic valve implantation (TAVI) that women have over men relates to the baseline left ventricular ejection fraction (LVEF). In this study, the survival benefit for women was only observed in patients with preprocedural LVEF ≤50%.
GE Healthcare announced that it has received an indication approval from the FDA for its imaging agent Visipaque (iodixanol) Injection. Visipaque 320mg Iodine/mL is an iso-osmolar agent that is now approved for use in coronary computed tomography (CT) angiography to assist in the diagnostic evaluation of adult and paediatric patients 12 years of age or older with suspected coronary artery disease in the USA.
LivaNova has announced it has acquired the remaining outstanding interests in Caisson Interventional in support of its strategic growth initiatives. Based in Maple Grove (USA), Caisson is a privately held clinical-stage medical device company focused on the design, development and clinical evaluation of a novel transcatheter mitral valve implantation (TMVI) implant with a fully transvenous delivery system.
Ambarish Pandey (Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, USA) and others report in JAMA Cardiology that risk-adjusted 30-day readmission rates after myocardial infarction are not associated with in-hospital quality of care or clinical outcomes after the first 30 days after discharge. This finding, the authors say, has implications because US hospitals are penalised if they have a higher than expected risk-adjusted 30-day readmission rate.
The ENVISAGE-TAVI AF is the first study to evaluate the effects of a novel oral anticoagulant on clinical outcomes exclusively in atrial fibrillation patients following successful transcatheter aortic valve implantation (TAVI). A press release reports that the study edoxaban (Lixiana) adds to the growing Edoxaban Clinical Research Programme (ECRP) evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings.
Teleflex has announced 510(k) clearance from the FDA for its AC3 Optimus intra-aortic balloon pump (IABP). A press release reports that device helps a weakened heart pump blood and can deliver IABP therapy to a broad range of patients, even those not previously considered candidates for IABP therapy. Clinicians may use the pump on patients with the most severe arrhythmias or with heart rates as high as 200 beats per minute.
Philips has announced the results from a global study indicating that automated three-dimensional echocardiographic (3DE) analysis of left-heart chambers is an accurate alternative to conventional manual methodology. This multicentre study assessed Philips HeartModelA.I Anatomically Intelligent Ultrasound (AIUS) software and builds on the conclusions of the previous clinical assessments carried out at individual locations by affirming consistency and reproducibilty across multiple laboratories.
Abiomed announced today the enrolment of the first patient in the FDA approved prospective feasibility study, STEMI Door to Unloading (DTU) with Impella CP system in acute myocardial infarction. This trial will focus on feasibility and safety of unloading the left ventricle using the Impella CP heart pump prior to primary percutaneous coronary intervention (PCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock with the hypothesis that this will potentially reduce infarct size.
LivaNova has announced the presentation of data from multiple studies demonstrating the safety and the effectiveness of the Perceval sutureless valve for aortic valve replacement patients and the Memo 3D ReChord for mitral valve repair. The three data presentations on Perceval, which included a late-breaking clinical trial and a poster presentation on the Memo 3D ReChord, were unveiled at the American Association for Thoracic Surgery (AATS) Centennial meeting (29 April—3 May, Boston, USA).
The FDA has approved Medtronic’s Resolute Onyx drug-eluting stent, which the company has now launched in the USA.
Having a non-O blood group is associated with a higher risk of heart attack, according to research presented at Heart Failure 2017 and the 4th World Congress on Acute Heart Failure.
The US Food and Drug Administration (FDA) has classified Medtronic’s recently initiated voluntary field action related to its HVAD system controllers and direct current adapters as a class I recall.
A meta-analysis of single-centre studies indicates that the use of the transaortic appraoch in patients undergoing transcatheter aortic valve implantation (TAVI) is associated with acceptable short-term safety and efficacy outcomes. These findings suggest, adding to previously published data, the transaortic approach can be used when the preferred transfemoral approach is not feasible.
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