Simon Wilson (Royal Infirmary of Edinburgh, Edinburgh, UK) and others report in EuroIntervention that the use of a novel microcatheter with a guidewire locking mechanism (NHancer, Interventional Medical Device Solutions) was associated with a 85.9% overall technical success rate in patients with chronic total occlusions undergoing percutaneous coronary intervention (PCI). They add that use of the catheter, for chronic total occlusion PCI, may lead to improved primary wiring and procedural success rates.
Musa A Sharkawi (Department of Cardiovascular Medicine, Hartford Hospital, Hartford, USA) and others report in Catheterization and Cardiovascular Interventions that the CADILLAC risk score could be used to determine which patients with ST-segment elevation myocardial infarction (STEMI) are at low risk for events after percutaneous coronary intervention (PCI) and, therefore, could be discharged from hospital before the recommended three days.
Boston Scientific has agreed to acquire certain manufacturing assets and capabilities of the Neovasc advanced biological tissue business, as well as a 15% equity stake in Neovasc, for a total of US$75 million in cash. The Neovasc advanced biological tissue business makes elements used in transcatheter heart valves, including the Boston Scientific Lotus valve system.
Cardiac Dimensions has received FDA approval for its investigational device exemption (IDE) CARILLON trial. The multicentre, blinded, randomised controlled trial is designed to evaluate the Carillon mitral contour system compared with guideline-directed medical management for the treatment of symptomatic functional mitral regurgitation associated with heart failure.
Medtronic’s HVAD system left ventricular assist device (LVAD) has received the CE mark for a less-invasive implant procedure in patients with advanced heart failure. The HVAD system is the first centrifugal LVAD to be approved in the EU for implantation via this new thoracotomy procedure.
Toshiba Medical’s Forward projected model-based iterative reconstruction solution (FIRST) and Vantage Titan 1.5T/cS edition with M-Power v3.6 software have received US Food and Drug Administration (FDA) clearance.
Amsel Medical Corporation is to present initial animal results of its “A Novel Mechanical Closure Device for Left Atrial Appendage Orifice and Closure of Right Atrial Incision” research at the upcoming 2016 International Conference for Innovations in Cardiovascular Systems (ICI) Meeting (December 4-6; Tel Aviv, Israel).
Valtech Cardio has agreed to be acquired by Edwards Lifesciences. The acquisition will give Edwards access to Valtech’s Cardioband reconstruction system (Cardioband) for transcatheter repair of the mitral and tricuspid valves. The device, which received the CE mark last year, is designed to allow physicians to repair the mitral valve in a first-line setting while preserving the option to perform future percutaneous or surgical valve repair and/or replacement.
Neovasc has received both regulatory and ethics committee approval to initiate the Tiara transcatheter mitral valve replacement study (TIARA II) in Italy. The study will be a 115-patient, non-randomised, prospective clinical study that will evaluate the safety and performance of the Tiara transcatheter mitral valve with the Tiara transapical delivery system.
At the 2016 meeting of the Radiological Society of North America (RSNA; 27 November–2 December, Chicago, USA), Siemens Healthineers has unveiled the robot-supported ARTIS pheno angiography system, which was developed for use in interventional radiology, minimally invasive surgery, and interventional cardiology. In addition to possessing a zen40HDR flat panel detector and GIGALIX X-ray tube (designed to provide outstanding image quality), the ARTIS pheno also has new 2k recording technology capable of delivering 2D imaging resolution that is four times higher in all recording processes than prior Siemens Healthineers systems.
With the introduction of the AquilionTM ONE/GENESIS Edition, the new system from Toshiba Medical that builds upon a 10-year history of leadership in area detector CT, Toshiba Medical is aiming to transform clinical confidence, the patient experience and providers’ workspace.
OrbusNeich launched its latest generation dual therapy stent, the Combo Plus. According to a press release, the Combo Plus has a unique anti-CD34 antibody biological coating that offers an advanced approach to active vessel healing combined with improved deliverability for patients with complex coronary artery disease. The press release reports that multiple design features make the stent a unique and effective option for treating coronary stenosis.
Valentin Fuster (director of Mount Sinai Heart and physician-in-chief of The Mount Sinai Hospital, New York, USA) and Jeffrey W Olin (professor of Cardiology and Director of the Vascular Medicine and Vascular Diagnostics Laboratory at the Icahn School of Medicine at Mount Sinai) both received awards at the American Heart Association (AHA) scientific sessions (12–16 November, New Orleans, USA). The International Academy of Cardiovascular Sciences awarded Fuster with the Medal of Merit: the highest honour of the Academy is bestowed for outstanding achievements in cardiovascular education and research.
The results of the FUTURE (Functional testing underlying revascularisation) trial indicate that the use of fractional flow reserve (FFR) to guide treatment—medical management, percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG)—in patients with multivessel disease may be associated with significantly higher mortality than the use of standard treatment (angiography).
BioVentrix has announced the first clinical use in the Netherlands of its closed-chest Revivent transcatheter (TC) ventricular enhancement system. The less invasive ventricular enhancement (LIVE) procedure was performed by cardiothoracic surgeon Patrick Klein and by interventional cardiologist Pierfrancesco Agostoni at the St Antonius Hospital (Nieuwegein, The Netherlands).
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