Marking the 30th anniversary of the publication of their first joint guidelines for the diagnosis and treatment of heart disease, the American College of Cardiology and the American Heart Association have published an extensive review of the process and methodology for evaluating cardiovascular research and writing practice guidelines for clinicians.
Northwestern Medicine is pleased to welcome James D Thomas, the new director of the Center for Heart Valve Disease at the Bluhm Cardiovascular Institute.
Sorin Group has announced that it has received US Food and Drug Administration (FDA) approval for the Solo Smart aortic pericardial heart valve.
Tryton Medical has announced that the first patient has been enrolled in the EXTENDED Access Registry (Tryton IDE XA registry), a single arm study of its Tryton Side Branch stent. The Tryton IDE XA registry is designed to support FDA submission for US approval and is expected to enrol 133 patients from Europe and the United States. Indulis Kumsars of P Stradins University Hospital, Latvian Centre of Cardiology enrolled the first patient.
Running for only a few minutes a day or at slow speeds may significantly reduce a person’s risk of death from cardiovascular disease compared to someone who does not run, according to a study published in the Journal of the American College of Cardiology.
Sorin Group has announced that it has been granted CE mark certification for its innovative stented aortic bioprosthesis Crown PRT (Phospholipid Reduction Treatment), now commercially available in Europe.
Boston Scientific has received CE mark approval and begun the European market launch of the Agent paclitaxel-coated PTCA balloon catheter. The Agent drug-coated balloon provides physicians with an additional alternative to treat both in-stent restenosis and de novo small vessel coronary disease.
Revised guidance from the National Institute for Health and Care Excellence (NICE), recommends once-daily, oral antiplatelet prasugrel (Efient), in combination with aspirin, as a cost-effective option when compared to generic clopidogrel, for a wider group of acute coronary syndrome patients having primary or delayed percutaneous coronary intervention (PCI).
The Cardiovascular Cell Therapy Research Network (CCTRN) has selected Cytori Therapeutics to supply adipose-derived regenerative cells (ADRCs) for a clinical trial aimed at evaluating the safety and feasibility of treating patients with Left Ventricular Assist Devices (LVADs). The CCTRN is supported by grants from the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH). This trial, named CELLVAD-ADRC, will explore outcomes following administration of a regenerative cell preparation from adipose tissue into the patient’s heart muscle 60 to 90 days after placement of an LVAD.
Miracor Medical Systems has announced the successful launch of its next-generation PICSO impulse system for the treatment of myocardial infarction. The new PICSO (Pressure-controlled intermittent coronary sinus occlusion) impulse system, consisting of the impulse console and impulse balloon catheters, is CE-marked and has already been used to treat patients in the UK, Ireland, and Hungary.
Transcatheter Technologies has announced that results of a first-in-human clinical study of its Trinity transcatheter aortic valve implantation (TAVI) system have been published ahead of print publication in the July issue of the peer-reviewed medical journal EuroIntervention (“Trinity heart valve prosthesis—a novel repositionable and retrievable transapical transcatheter aortic valve system”).
Biosensors has announced enrolment of the initial patient in BioFreedom USA, an investigational device exemption (IDE) feasibility trial designed to collect additional US-based safety and effectiveness data for BioFreedom, the company’s novel polymer and carrier-free drug-coated stent. The company believes this is the first clinical trial within the USA to evaluate a polymer-free drug-coated stent. Results from this study will support a future pivotal IDE study in the USA.
Corindus Vascular Robotic will host the breakfast symposium “Robotic PCI: Precision and protection from occupational hazards” at the upcoming Transcatheter Cardiovascular Therapeutics meeting (TCT; 13–17 September, Washington, USA). The symposium will highlight presentations from renowned interventional cardiologists on the advantages offered by robotic-assisted percutaneous coronary intervention (PCI) procedures.
Medtronic has announced that it has received the CE mark for its 23mm CoreValve Evolut R system for transcatheter aortic valve implantation (TAVI). A company press release states that the novel, self-expanding valve and 14FR equivalent delivery system offers new capabilities that advance valve performance and deliverability during the procedure, while providing the option to recapture (re-sheath the valve back into the catheter) and reposition (move the valve to a new position either above or below its current placement) the valve during deployment phase, if needed.
Dan Atar (Department of Cardiology, Oslo University Hospital, Norway) told ESC delegates that the MITOCARE study indicates that the novel agent TRO40303 does not provide any protective effect compared with placebo in preventing reperfusion injury in STEMI patients undergoing primary PCI. This study, combined with many other failed trials, leads to new insights on how successful modern therapy of STEMI has become.
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