The FDA has issued a warning letter to an investigator in the Medtronic CoreValve US Pivotal Trial. The letter cites numerous serious violations relating to the treatment of subjects in the trial testing the experimental Medtronic TAVI (transcatheter aortic valve implantation) device. The violations were uncovered during an FDA inspection last summer.
Un fármaco que se usa frecuentemente para tratar la insuficiencia cardiaca crónica podría no aliviar los síntomas en las personas con una forma de la enfermedad
The Montage 2™ is the only approved filter system protecting the carotid arteries capturing embolic debris during intravascular procedures such as Transcatheter Aortic Valve Repair (TAVR).
Cardiovascular Systems presented three-year data from its ORBIT I feasibility study of calcified coronary lesions during a poster session at the 2013 Cardiovascular Research Technologies (CRT; 23–26 February 2013, Washington, USA) conference.
A new study, published ahead of print in the Journal of the American College of Cardiology, suggests that transcatheter aortic valve implantation (TAVI) is associated with acceptable results in patients with severe native aortic valve regurgitation without stenosis who are not candidates for surgical valve replacement.
Direct Flow Medical has announced that both the US Patent and Trademark Office and the Japanese Patent Office have awarded the company patents for its proprietary design of a transcatheter aortic valve implantation (TAVI) system.
Medtronic has announced that the FDA has approved two new lengths—34mm and 38mm—of its Resolute Integrity drug-eluting stent in the diameters of diameters of 3mm, 3.5mm and 4mm with an indication for patients with diabetes.
Abbott Vascular shed another 450 employees Thursday, Feb. 21, continuing a series of job cuts that began last year.
Volcano Corporation (Nasdaq: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, is providing additional guidance for 2013 on an as reported basis to augment guidance provided on a constant currency basis in its fourth quarter 2012 earnings news release earlier today.
La extirpación toracoscópica del apéndice auricular izquierdo evita la tromboembolia sin anticoagulación en los pacientes con fibrilación auricular (FA) no valvular.
OrbusNeich today announced that OrbusNeich Medical GmbH and Orbus International B.V., subsidiaries of OrbusNeich Medical, Inc., (collectively, "OrbusNeich") have commenced patent infringement actions in Germany and The Netherlands against Boston Scientific Corporation (BSX) ("Boston Scientific") and its distribution affiliates in those countries
CardioDx has announced that the COMPASS (Coronary Obstruction Detection by Molecular Personalized Gene Expression) study has been published in Circulation: Cardiovascular Genetics and indicates that the Corus CAD test outperforms myocardial perfusion imaging in overall diagnostic accuracy for obstructive coronary artery disease.
The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) have been given FDA investigational device exemption (IDE) approval to study alternative access routes with transcatheter aortic valve implantation (TAVI)—the IDE approval is believed to be a first for any medical specialty society.
IP protection includes PICSO® method and algorithms that ensure stable and repeatable PICSO® treatment designed to enhance myocardial perfusion following primary PCI in STEMI patients
Loma Vista Medical has established a direct sales force within the United States and a network of seven European distributors working to commercialize the world’s first ultra-precise balloon catheter specifically designed to meet the demands of transcatheter valve procedures.
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