A cohort study has found that medical devices approved first in the European Union (EU) are associated with a greater rate of post-marketing safety alerts and recalls compared with devices approved first in the USA.
RenalGuard Solutions has been featured in a high-risk coronary chronic total occlusion (CTO) live case presentation at the recent CTO Fundamentals Course, June 3, 2016, VU University Medical Center, Amsterdam, The Netherlands.
A simple preoperative echocardiographic measurement of the amount of torsion of the heart predicted outcomes of mitral valve surgery in some heart failure patients, according to a novel study published in JACC: Basic to Translational Science.
Medtronic has entered into a definitive agreement to acquire HeartWare for approximately US$1.1 billion.
Grant W Reed, Milind Y Desai (both Department of Cardiovascular Medicine, Centre for Radiation Heart Disease, Cleveland Clinic, Cleveland, USA) and others report in Circulation Cardiovascular Interventions that prior external beam radiation therapy is an independent predictor of both all-cause and cardiovascular mortality in patients undergoing percutaneous coronary intervention (PCI).
HeartFlow has announced that it has launched its next generation of its HeartFlow FFRct system. The result of years of development, the next-generation platform includes major advancements in the process and algorithms HeartFlow uses to calculate fractional flow reserve computed tomography (FFRCT). These technology advancements resulted in the second FDA clearance for HeartFlow’s technology.
The first patients have been treated using CorMatrix Cardiovascular’s Tyke.
The first patient has been enrolled in the FROST study at William Beaumont Hospital, Dearborn, USA. This AtriCure-sponsored trial will evaluate intraoperative cryoanalgesia therapy using cryoablation in conjunction with standard of care (SOC) pain management compared to SOC alone.
Positive results of a single-centre, retrospective study using the Neovasc Reducer have been published in The Netherlands Heart Journal. The paper documents the results from 23 consecutive patients who were implanted with the Reducer in order to treat their severe refractory angina.
Measuring antibody levels in the blood could be used to detect a person’s heart attack risk after researchers, part-funded by the British Heart Foundation, discovered that higher levels of these antibodies are linked to a lower heart attack risk.
Biotronik’s bioresorbable magnesium scaffold—Magmaris—is now CE mark approved, meaning it is now one of three bioresorbable scaffolds available on the European market (alongside Abbott Vascular’s Absorb and Elixir Medical’s Desolve). Magmaris is the first bioresorbable device to have a magnesium scaffold.
A study, which was presented at EuroPRevent 2016 (14–15 June, Sophia Antipolis, France), indicates that 15 minutes of daily exercise may be reasonable target for older adults. It found that such an exercise regimen was associated with a 22% lower risk of death. The study was presented at the meeting by David Hupin (Department of Clinical and Exercise Physiology, University Hospital of Saint-Etienne, Saint-Etienne, France).
Vasim Farooq (Department of Cardiology, Manchester Heart Centre, Manchester Royal Infirmary, Manchester, UK) and others report in Circulation Cardiovascular Interventions that the use of a vascular closure device after transfemoral percutaneous coronary intervention (PCI) is associated with a minor short-term mortality benefit compared with manual compression. They add that a more pronounced benefit was observed in certain subgroups of patients, such as those with acute coronary syndromes, at high risk of bleeding.
Stentys has announced that it has received the CE mark for the longest version (37mm) of its Xposition S sirolimus-eluting self-apposing stent. A press release reports that the approval of this longer version means that interventional cardiologists will now only need to implant a single self-apposing stent (in relevant longer lesions) rather than a long conventional stent, thus minimising the risk of malapposition and related complications.
The amount a heart “bleeds” following a myocardial infarction can predict the severity of future heart failure, according to research presented at the British Cardiovascular Society (BCS; 6–8 June, Manchester, UK). Bleeding, or bruising in the heart, affects more than 40% of people who suffer from a heart attack. The researchers have now found that this injury is associated with a higher risk of developing heart failure in the months following a heart attack.
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