Boston Scientific has announced a delay to the previously communicated timelines for the commercialisation of its Lotus Edge transcatheter aortic valve implantation (TAVI) device in Europe and the USA. Originally, the company said it hoped to re-introduce the device in Europe by early next year.
Joseph Ladapo (David Geffen School of Medicine, University of California, Los Angeles, USA) and others report in American Journal of Managed Care that—by reducing out-of-pocket costs for preventive treatment—the Affordable Care Act (ACA) may have encouraged more people to have health screenings related to their cardiovascular health.
Primary results from the REDUCE LAP-HF trial indicate that a novel interatrial shunt device (IASD, Corvia Medical) significantly reduced pulmonary capillary wedge pressure (PCWP) during exercise, compared with a sham procedure, in patients with heart failure and preserved ejection fraction (≥40%). Further studies are required to see if the mechanistic effect observed with the IASD will translate into sustained improvements.
Creavo Medical Technologies (Creavo) has won two awards at the Institution of Engineering and Technology (IET) Innovation awards (15 November, London, UK) for its cardiac imaging device (Vitalscan). The device is designed to help physicians accurately rule-out ischaemic heart conditions in a matter of minutes. The awards aim to celebrate the very best in new innovations in science, engineering and technology, showcasing entries from around the world.
A study published in the Journal of the American College of Cardiology indicates that people who regularly eat nuts—including peanuts, walnuts and tree nuts (eg. Brazil nuts)—have a lower risk of developing cardiovascular disease or coronary heart disease compared with those who never or almost never eat nuts. The study is the largest to date looking at frequency of nut consumption in relation to incident cardiovascular disease.
Stentys has announced the precommercialisation of its Serpentis stent. According to a press release, the sirolimus-eluting stent has a biodegradable coating and is designed for routine procedures. Now that the device has the CE mark, Stentys plans for the stent to be precommercialised by the end of the year to a selection of pilot centres across Europe.
Philips has announced the results of a comprehensive, independent, two-year study demonstrating the clinical workflow benefits of its next generation image-guided therapy platform, Azurion.
Data published, as a research letter, in the Journal of the American College of Cardiology and presented at the American Heart Association’s Scientific Sessions 2017 (11–15 November, Anaheim, USA) indicate that only a small percentage of sudden cardiac arrests are related to sexual activity. However, of those events that do occur, death rates are high and rates of bystander cardiopulmonary resuscitation (CPR) are low.
Neovasc has received approval of the US FDA to initiate the COSIRA-II IDE clinical trial. The trial’s purpose will be to demonstrate the safety and effectiveness of the Reducer system for treatment of patients with refractory angina. Once completed, the trial data is intended to support an application to the FDA for approval to begin marketing Reducer in the USA.
Advice on percutaneous coronary intervention (PCI) strategies for patients with acute myocardial infarction complicated by cardiogenic shock may need to be revised after the CULPRIT-SHOCK study showed that immediate multivessel PCI was associated with a significantly higher rate of all-cause death than was culprit-lesion only PCI in this patient cohort. The study also indicated that multivessel PCI was also associated with a trend towards more renal replacement therapy.
Abbott has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved its MitraClip device for treatment of people with mitral regurgitation. Currently, the standard-of-care treatments for mitral regurgitation in Japan are limited to open-heart surgery and medication.
HeartFlow has announced that the Centers for Medicare & Medicaid Services (CMS) has finalised a new technology ambulatory payment classification (APC) for the HeartFlow FFRct analysis—a first-of-its-kind non-invasive technology that helps clinicians diagnose and treat patients with suspected coronary artery disease.
Data presented during the 2017 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Denver, USA), according to a press release, provide further evidence of the safety and efficacy of Biotronik’s bioresorbable scaffold Magmaris.
Acist has announced the global launch of its RXi Mini system—the next-generation system of its RXi Rapid Exchange fractional flow reserve (FFR) system. The system made its debut at the 2017 Transcatheter Cardiovascular Therapeutics (TCT) meeting last week.
The Fantom bioresorbable scaffold (Reva Medical) shows continued positive clinical outcomes according to an interim data set from the FANTOM II clinical trial, which was presented at the 2017 Transcatheter Cardiovascular Therapeutics (TCT) meeting this week. These interim data were for 125 patients followed through 24 months and indicated a low rate of major adverse cardiac event (MACE) of 5.6% and a single very late scaffold thrombosis event.
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