JenaValve Technology has announced it has received CE mark approval from European regulators for its transapical TAVI system for the treatment of aortic insufficiency.
Boston Scientific has completed enrolment in the EVOLVE II randomised, controlled clinical trial. The EVOLVE II trial is designed to further assess the safety and effectiveness of the Synergy coronary stent system.
El Camino Hospital (Mountain View, USA), in partnership with the Taft Center for Clinical Research and the Fogarty Clinical Research Institute, both a part of the Fogarty Institute for Innovation, announces that it has enrolled its second patient in a global clinical trial comparing the CoreValve System (Medtronic) with surgical aortic valve implantation in patients with severe aortic stenosis who are at intermediate risk for open-heart surgery.
CardioLogical Solutions reports successful completed in vivo validation of its transcatheter aortic valve implantation (TAVI) access-and-closure device (VasoStitch).
Corindus Vascular Robotics has announced launch of the PRECISION Registry, an on-going study that will collect data on the safety and effectiveness of the use of the CorPath robotic angioplasty system in percutaneous coronary intervention (PCI) procedures
The novel anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) should not be used to reduce the risk of stroke in patients with mechanical heart valves, the RE-ALIGN study has concluded. Its results indicate that compared with warfarin, the drug was associated with increased thromboembolic events and bleeding complications in this patient population.
Keystone Heart has announced that it can now commercially market its cerebral protection device, Triguard, for use in transcatheter aortic valve implantation (TAVI) procedures as the device has been awarded the CE mark.
Direct Flow Medical has announced that the first patient in its US SALUS clinical trial, which is evaluating the company’s transcatheter aortic valve implantation (TAVI) device, has been enrolled. The non-randomised, multicentre, core lab-adjudicated, investigational device exemption (IDE) trial of 30 patients is being conducted at six US clinical sites.
Boston Scientific Corporation (BSX) is scheduled to participate at the annual EuroPCR Scientific Program May 21-24 in Paris.
Results from the BIOSOLVE-I study that were presented at the EuroPCR have demonstrated the excellent safety profile of the DREAMS drug-eluting absorbable metal scaffold. Michael Haude, Lukaskrankenhaus, Neuss, Germany, one of the study s investigators, presented the results.
Primary end-point results from the BIOFLOW-II Clinical Study demonstrating the non-inferiority of the BIOTRONIK Orsiro Hybrid Drug-Eluting Stent compared to Abbott s XIENCE PRIME™. These results were presented in a late-breaking clinical trials session at the EuroPCR congress in Paris by principal investigator, Prof. Stephan Windecker, MD of University Hospital Bern, Switzerland.
Las personas mayores que sufren de un tipo de arritmia cardiaca conocida como fibrilación auricular también podrían ser más propensas a experimentar declives mentales antes, sugiere un estudio reciente.
Abbott Vascular has announced the publication of two European post approval studies for its transcatheter device, MitraClip, for mitral regurgitation. ACCESS-EU, which was published in the Journal of American College of Cardiology, and the Transcatheter mitral valve interventions (TRAMI) registry, which was published in EuroIntervention, both show positive outcomes for the device.
Biosensors has entered into a licensing agreement with Eurocor for its drug-eluting balloon technology and related intellectual property rights in relation to the treatment of both coronary and peripheral artery disease. As a first step in this process, Biosensors will market and sell, under its own brand, drug-eluting balloons manufactured by Eurocor.
A substudy of the BIOFLOW-II trial, presented as a late-breaking trial at EuroPCR (21–24 May, Paris, France), showed that Biotronik’s drug-eluting stent with a biodegradable polymer (Orsiro) was non-inferior to a drug-eluting stent with a durable polymer (Xience Prime, Abbott Vascular) in terms of in-stent late lumen loss at nine months.
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