Martial Hamon (Department of Clinical Research, University of Caen, Caen, France) and others report in Circulation: Cardiovascular Interventions, according to the results of a prespecified analysis of the EUROMAX (European ambulance acute coronary syndrome) trial, that the transradial approach for coronary interventions is not associated with significantly better 30-day clinical outcomes compared with the transfemoral approach—this goes against the findings of previous studies.
HeartWare has commenced its MVAD system CE mark international clinical trial. The first patients receiving the MVAD Pump were implanted at the Freeman Hospital in Newcastle-upon-Tyne, UK, and at the Medical University AKH Vienna in Austria.
OrbusNeich has announced that the first patient has been enrolled in the clinical study in China of its Combo dual therapy stent. The China Recovery Study is designed to evaluate the stent’s performance compared with the Nano stent (Lepu Medical Technology). The first patient was enrolled by Yuan Ming at The First Affiliated Hospital of the Fourth Military Medical University, Xian, China, in May.
Boston Scientific has initiated a study to evaluate its fully resorbable scaffold technology. FAST (Fully absorbable scaffold feasibility study) is a prospective, single-arm study designed to assess the safety and performance of this next-generation scaffold for the treatment of atherosclerotic coronary lesions.
Vital Images´ 510(k) FDA-cleared computed tomography (CT) myocardial perfusion application is debuting at the 10th Annual Scientific Meeting of the Society of Cardiovascular Computed Tomography (SCCT; 16–19 July, Las Vegas).
According to a new survey published in EuroIntervention, men state that the long working hours and the need to be on call associated with being an interventional cardiologist are the key reasons why so few women choose the subspecialty. However, female respondents in the survey said that “lack of opportunity” and “radiation” were the main reasons for not choosing to become an interventional cardiologist.
Aurora St Luke’s Medical Center (Milwaukee, USA), a national leader in heart and vascular care, has become the first hospital in the world to use 4D ultrasound software, designed by GE Healthcare, to evaluate heart conditions. A GE Healthcare press release reports that the software enables healthcare professionals to see “with life-like clarity” the chambers, valves, vessels, and other intricate structures of the heart in 4D.
Cardiovascular Systems has completed enrolment in COAST (Coronary orbital atherectomy system trial), which is designed to assess the safety and efficacy, as well as economic outcomes, of the company’s new micro crown Orbital Atherectomy System (OAS) for the management of severely calcified coronary lesions in patients with coronary artery disease.
Thoratec has announced that its HeartMate PHP (Percutaneous Heart Pump) has received CE mark approval, permitting sale in the EU and other international countries. The approval was based on data from the first 30 patients enrolled in the HeartMate PHP SHIELD I CE mark trial, which is examining use of PHP to support patients undergoing a high-risk percutaneous coronary intervention (PCI) procedure. Data from all 50 patients enrolled in this study will be presented later in 2015.
Edwards Lifesciences has announced that it has agreed to acquire CardiAQ Valve Technologies, a privately held company and developer of a transcatheter mitral valve implantation (TMVI) system. CardiAQ has received a FDA investigational device exemption (IDE) approval to conduct an early feasibility study of its TMVI system of up to 20 patients, and also plans to initiate a CE Mark study in Europe.
Sorin has announced the global launch of its latest generation of heating and cooling system. The company reports that the FlexTherm—the newest addition to Sorin Heartlink System—is fully integrated with Sorin S5 industry-leading heart-lung machine. The new system is equipped with three water tanks, each with a different temperature setting, allocated to three independent water circuits.
Judith Kooiman (Leiden University Medical Center, The Netherlands) and others report in Circulation: Cardiovascular Interventions that nearly one third of in-hospital deaths after percutaneous coronary intervention (PCI) can be attributed to acute kidney injury. They also state that preventing nine cases of acute kidney injury could potentially prevent one death.
The FDA has strengthened an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a myocardial infarction or stroke. NSAID prescription labels and information labels for over-the-counter, non-aspirin NSAIDs already contain details about the potential risks of myocardial infarction and stroke with the drugs.
The Carillon Mitral Contour System is projected to be a cost-effective treatment option when compared to a typical regimen of optimal medical treatment, the present standard of care for functional mitral regurgitation. This finding has been established in a new study published in BMC Cardiovascular Disorders.
Thoratec has begun enrolment in the SHIELD II US clinical trial examining the HeartMate PHP in patients undergoing a high-risk percutaneous coronary intervention (PCI) procedure. The first case was performed by interventional cardiologist Robert Pyo at Montefiore Medical Center, Albert Einstein College of Medicine, New York, USA.
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