BioCardia has revealed the trial design for its pivotal Phase III CardiAMP Heart Failure Trial at the Texas Heart Institute International Symposium on Cardiovascular Regenerative Medicine (15–16 September, Houston, USA).
Carag has announced that it has completed CE marking for its Carag bioresorbable septal occluder. A press release reports that the device is a first-in-class structural heart device for treatment of common heart defects. It adds that the bioresorbable septal occluder was developed and clinically tested by Carag and is the world’s first transcatheter septal occluder, employing a framework that is fully resorbed by the human body.
Jochen Wöhrle (Department of Internal Medicine II, Cardiology, University of Ulm, Ulm, Germany) and his team report in JACC: Cardiovascular Interventions that, in an all-comer population, patients who underwent transcatheter aortic valve implantation (TAVI) with the Sentinel embolic protection device (Claret Medical) had a significantly higher rate of stroke-free survival at seven days than did patients who underwent TAVI without the device.
Anand Prasad (Department of Medicine, Division of Cardiology, University of Texas Health Science Center, San Antonio, USA) and others report in the Journal of Interventional Cardiology that the use of RenalGuard in patients undergoing interventional cardiology procedures is associated with significant reductions in all-cause mortality, the need for dialysis, and major adverse cardiovascular and cerebrovascular events (MACCE) in the both short- and long-term.
Evan Zahn (Guerin Family Congenital Heart Program, Cedars-Sinai Heart Institute, Los Angeles, USA) has become the first interventional cardiologist to implant the Alterra adaptive prestent device (Edwards Lifesciences) to reshape the right ventricular outflow tract (RVOT) of a patient’s malformed pulmonary valve. The procedure was the first in a new, early feasibility clinical trial that has been approved by the FDA.
The Cardiovascular Research Foundation (CRF) has release details of the 12 late-breaking trials and 16 first report investigations that are to be presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2017 scientific symposium (29 October–2 November, Denver, USA).
Corindus Vascular Robotics has announced that the first patient has been enrolled in its PRECISION GRX registry, which is a post-market study of its second-generation CorPath GRX system—a robotic-assisted percutaneous coronary intervention (PCI) device. The goal is for 1,000 patients, across 25 different sites, to be enrolled in the registry.
Corey Adams (Health Science Center, St John’s, Canada) and others report in the latest issue of Innovations that the Perceval sutureless aortic valve (LivaNova) is a safe aortic valve replacement option that provides a shorter procedure and recovery time, along with favourable haemodynamics for patients. Their literature review included a meta-analysis of 89 studies.
Alvimedica has announced that the Court of Dusseldorf (Germany) has recognised in full the CID-Alvimedica rights on intellectual properties regarding the principles and related technology on drug release from a stent through reservoirs on the outer surface (abluminal reservoir technology).
Of 5,691 adverse events following transcatheter aortic valve implantation (TAVI) that were reported to the FDA’s manufacturer and user facility device experience (MAUDE) database, only 30 related to clinical or symptomatic leaflet thrombosis. However, these events were associated with serious clinical manifestations including stroke, cardiogenic shock, and death.
Abbott has announced that it is to stop selling its first-generation bioresorbable vascular scaffold (Absorb, Abbott Vascular) because of poor sales. The announcement follows the publication of the Absorb III two-year results, which showed Absorb to be associated with a significantly higher rate of target lesion failure than was the company’s everolimus-eluting, metallic stent Xience.
Micro Interventional Devices has announced that its minimally invasive annuloplasty (MIA) technology has been successfully used for the first time to perform a tricuspid valve bicuspidisation procedure. The bicuspidisation, a press release reports, resulted in a 34.5% reduction in valve area, reducing the patient’s tricuspid regurgitation from severe/moderate to trace.
Data from a nationwide observational cohort study indicate that coronary artery bypass grafting (CABG) should be used instead of percutaneous coronary intervention (PCI) to revascularise patients with multivessel disease and type 1 diabetes. The study found that PCI was associated with a five-fold increased risk of repeat revascularisation compared with CABG in this patient cohort.
The American College of Cardiology and several partnering societies—including the American Heart Association (AHA) and Society for Cardiovascular Angiography and Interventions (SCAI)—have released a joint appropriate use criteria document for the treatment of valvular heart disease. The document reviews the evaluation and use of multimodality imaging in the diagnosis and management of the disease.
The FDA has approved the Full MagLev HeartMate 3 (Abbott) left ventricular assist device for use in heart failure patients in need of short-term haemodynamic support (eg. bridge-to-transplant or bridge to myocardial recovery). The device, a press release reports, is designed to provide patients with new benefits that embody the LVAD therapy—such as improved blood flow in a pump that uses full magnetic levitation to reduce trauma to blood passing through the system.
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