The MobiusHD minimally invasive system from Vascular Dynamics has been granted CE mark approval for the treatment of resistant hypertension.
The mechanism by which blood glucose levels can affect the contraction of blood vessels has been demonstrated for the first time by a team from the University of Leicester, UK.
A pre-specified substudy of BIOSCIENCE, published in EuroIntervention, has found that a sirolimus-eluting stent with a biodegradable polymer (Orsiro, Biotronik) is associated with a significantly lower rate of target lesion failure than is an everolimus-eluting stent with a durable polymer (Xience, Abbott Vascular) in patients with ST-segment elevation myocardial infarction (STEMI).
Vivasure Medical has been granted CE mark approval for its fully bioabsorbable percutaneous vascular closure device for large-bore femoral arteriotomies. According to Vivasure, this is the world’s first approved bioabsorbable, sutureless and fully synthetic option to close large arteriotomies, which result from percutaneous transcatheter procedures.
QT Vascular and its subsidiaries have announced the release of the initial results from the first-in-human (FIH) study of its unique drug-coated balloon, Chocolate Heart.
A new classification of coronary congenital diseases has been suggested to help surgeons identify secondary defects in the operating theatre. The scheme is outlined in a novel European Society of Cardiology (ESC) position paper published in Cardiovascular Research. Clinical cardiologists will also know what to look for on cardiovascular images.
The Medicines Company has initiated study sites, and begun enrolling patients, in the ORION-1 phase 2 study. ORION-1 will compare the effects of differenct ALN-PCSsc doses given as subcutaneous injections in a quarterly or bi-annual dosing regimen in patients with atherosclerotic cardiovascular disease (ASCVD) or risk equivalent ASCVD and elevated LDL-C.
St Jude Medical has launched the ILUMIEN III clinical trial, which is a prospective, international, randomised trial that will evaluate the clinical benefits of the company’s optical coherence tomography (OCT) guidance system during stent implantation compared with that of intravascular ultrasound (IVUS) or angiography alone. By assessing each diagnostic system head-to-head, the study aims to offer a clearer insight into OCT’s ability to influence clinical outcomes.
Sorin and Cyberonics have unveiled LivaNova as the name of their combined company, effective at the close of their proposed merger.
The first patients have been enrolled in Cardiac Dimensions’ REDUCE FMR clinical trial. REDUCE FMR is a prospective, double-blind, randomised multicentre trial, evaluating the company’s minimally-invasive Carillon mitral contour system.
Cell Therapy has reported average 24-month (19–29 months) major adverse cardiac events (MACE)-free survival for all patients in the Heartcel trial studying myocardial regeneration. This means that in these patients, suffering from advanced heart failure, all are still alive after an average of two years despite an expected annual mortality rate of up to 70%, and none have suffered cardiac events such as a heart attack or stroke.
SentreHeart has received approval for an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) to begin enrolment in a clinical study of the Lariat suture delivery device. The randomised, controlled clinical study, known as the AMAZE trial, will evaluate the use of the Lariat device for the ligation of the left atrial appendage (LAA) as an adjunctive treatment to ablation in patients with persistent or long-standing persistent atrial fibrillation.
Robin Mathews (Duke Clinical Research Institute, Duke University Medical Centre, Durham, USA) and others report, in Circulation: Cardiovascular Quality Outcomes, that patients with low adherence to prescribed medication after a myocardial infarction are more likely to report difficulty in understanding written communication and a lack of information about the risks of non-adherence than patients with high adherence. Therefore, the authors advise tailored patient education may represent an opportunity to optimise patient adherence.
A matched comparison study, published in JACC: Cardiovascular Interventions, indicates that the Lotus device (Boston Scientific) is associated with significantly greater device success than is the CoreValve device (Medtronic) in patients with high- or extreme-risk severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). However, device success did not translate into a mortality benefit at 30 days with Lotus.
Medtronic has announced that the FDA has approved its recapturable, self-expanding CoreValve Evolut R transcatheter aortic valve implantation (TAVI) system—making it the first-and-only recapturable and repositionable device available in the USA. The system is approved for the management of severe aortic stenosis patients who are at high or extreme risk for surgery.
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