Arterial Remodeling Technologies (“ART”) reported today that the Company has achieved a medical milestone with its “ARTDIVA” (Arterial Remodeling Transient DIsmantling Vascular Angioplasty) clinical trial: the successful First-in-Human implantation of its novel biodegradable stent into an 61-year-old male who was suffering from a blocked coronary artery and needed a percutaneous coronary intervention (PCI). ART’s next-generation bioresorbable stent is designed to promote positive arterial remodeling and then bioresorb in approximately 18 months.
AstraZeneca (NYSE: AZN) announced today that a combined panel of experts from the American College of Cardiology Foundation (ACCF) and American Heart Association (AHA) have updated their guidelines to include a Class I recommendation for the use of the oral antiplatelet medicine, BRILINTA® (ticagrelor) tablets in patients with Unstable Angina (UA) or Non–ST-Elevation Myocardial Infarction (NSTEMI) managed both invasively and non-invasively.
A novel ultrasound technique may help prevent stroke after a heart attack. Also this week, homing in on ways to better treat idiopathic pulmonary arterial hypertension.
Rcadia Medical Imaging announced results of an initial study intended to demonstrate the feasibility of a proprietary technique that uses coronary CT angiography studies (cCTA) as a non-invasive alternative to assess the haemodynamic significance of coronary lesions
MiCardia Corporation, a privately held medical device company, announced today that it had completed an internal round of funding, which will provide the Company with $4.4 million during 2012 and 2013. MiCardia plans to use the proceeds of this funding to expand the commercialization of its enCorSQ Mitral Valve Repair SystemTM in Europe and select countries worldwide.
La enfermedad coronaria aterosclerótica es uno de los principales problemas de salud pública y que más recursos consume en los sistemas sanitarios de Europa. Hasta ahora, no se disponía de un abordaje claro para su diagnóstico ni se habían establecido las técnicas de imagen más adecuadas para cada caso concreto, lo que ha incrementado el gasto sanitario europeo. Con el fin de corregir esta tendencia, se puso en marcha hace tres años el estudio EVINCI (EValuation on INtegrated Cardiac Imaging), diseñado por la Sociedad Europea de Cardiología (ESC), cuyos resultados preliminares, presentados el pasado 26 de junio en el encuentro internacional final de EVINCI celebrado en el Hospital Universitario Ramón y Cajal de Madrid, demuestran que el 75 por ciento de las pruebas invasivas que se realizan para diagnosticar esta enfermedad se podrían evitar. Y es que, el estudio ha determinado que la prevalencia de la enfermedad coronaria arterosclerótica en pacientes con síntomas de dolor de pecho es más baja de lo que se esperaba en Europa.
The US Food and Drug Administration (FDA) has given 510(k) clearance to St Jude Medical to market its ViewFlex Xtra Intracardiac Echocardiography (ICE) catheter. This new technology is designed to be used with the ViewMate Z Ultrasound console, a system that provides fast, clear images to help visualise cardiac structures and blood flow within the heart during complex electrophysiology or interventional procedures.
The metabolic syndrome is associated with faster progression of aortic stenosis, researchers reported. But the association was significant only in patients 57 years of age or younger, according to Philippe Pibarot, DVM, PhD, of Laval University in Quebec City, and colleagues.
Sorin Group (SRN.MI)(Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today a minority investment in Cardiosolutions Inc., an early-stage company focused on the development of an innovative percutaneous system to treat patients with moderate to severe mitral valve regurgitation.
A new study finds that the use of drug-eluting stents after angioplasty bears little relationship to patients predicted risk of restenosis (reblockage) of the treated coronary artery, the situation the devices are designed to prevent. In an Archives of Internal Medicine paper receiving early online publication, a multi-institutional research team reports that the devices are used in treating more than 70 percent of patients at low risk of restenosis. Since patients receiving these stents need to take costly anticlotting medications for at least a year – medicines that also have clinical risks – the benefits of drug-eluting stents may not outweigh the risks, inconvenience and costs of the devices for those patients. In addition, the authors note, reducing unnecessary usage of drug-eluting stents could significantly cut U.S. health costs.
Many heart patients get newer, pricey stents inserted during artery-clearing procedures, even if it s not clear they d be worse off with more basic models, a new study suggests.
Cardionovum GmbH announced today that it has initiated in vivo testing of its second drug-eluting balloon (DEB) RESTORE™. The Company is currently marketing a line of CE-marked paclitaxel-coated DEBs for (1) coronary (PRIMUS®) and (2) peripheral (LEGFLOW®) applications. Cardionovum is featured in the most recent issue of IN VIVO magazine.
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for vascular disease, today announced that two patients at two different hospitals were treated with its new, 6 French guide catheter-compatible, electric orbital atherectomy system. The treatments are part of CSI s ORBIT II trial, which is now over 70 percent enrolled. ORBIT II is evaluating the safety and effectiveness of CSI’s orbital technology in treating calcified coronary arteries.
Boston Scientific Corporation (BSX) has completed enrollment in the PREVAIL confirmatory study, designed to gain U.S. Food and Drug Administration (FDA) approval for the WATCHMAN® Left Atrial Appendage (LAA) Closure device. The prospective, randomized trial enrolled 407 patients at 42 sites and is comparing the WATCHMAN device to warfarin in high-risk patients with atrial fibrillation (AF) eligible for long-term warfarin therapy. Patient follow up of six months is required prior to submission to the FDA.
Edwards Lifesciences Corporation (EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received a conditional Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate the TRANSFORM Trial, a prospective, multi-center study that will evaluate the EDWARDS INTUITY valve system.
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