Boston Scientific has received FDA approval for the Rebel platinum chromium coronary stent system, the company’s latest generation bare metal stent for the treatment of coronary artery disease. Bare metal stents continue to play an important role in the treatment of coronary artery disease and represent a significant portion of the global stent market. The company announced CE mark approval for the Rebel stent system in February.
CorMatrix Cardiovascular has announced that it has received US Food and Drug Administration (FDA) clearance to market the CorMatrix ECM (extracellular matrix) for vascular repair.
A senior researcher in biomedical ethics (David Shaw, Institute of Biomedical Ethics, University of Basel, Basel, Switzerland) has said that the controversial use of delayed consent in HEAT-PPCI (Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention)—in which patient consent was not sought until after randomisation—was ethical and was actually preferable to obtaining consent immediately.
Giovanni Esposito (Division of Cardiology, Department of Advanced Biomedical Sciences, Naples, Italy) and others report that, in The American Journal of Cardiology, the results of a meta-analysis support previous findings that preoperative moderate-to-severe mitral regurgitation negatively affects outcomes after transcatheter aortic valve implantation (TAVI). However, the meta-analysis also suggests that there is a trend towards mitral regurgitation improvement after TAVI.
OrbusNeich has announced that the first patient has been enrolled in the Multinational abluminal sirolimus coated bio-engineered stent (MASCOT) post-marketing registry. The first Combo dual therapy stent implant was performed at the Amphia Hospital in Breda, The Netherlands.
AstraZeneca has announced that the American Heart Association/American College of Cardiology, in their updated the guideline for the management of patients with non–ST-elevation acute coronary syndromes (NSTE-ACS), has given Class IIa recommendation for use of ticagrelor (Brilinta) over clopidogrel in patients with NSTE-ACS undergoing early invasive or ischaemia-guided strategy or receiving a stent. A company press release reports that the guideline supports differentiation among currently available P2Y12 inhibitors, including ticagrelor, clopidogrel, and prasugrel, for these patients.
CFI Medical has announced CE mark approval for its Zero-Gravity suspended radiation protection system floor unit, paving the way for its widespread use internationally. Biotronik will continue to act as the exclusive distributor of Zero-Gravity outside North America. A press release, issued by Biotronik, reports that the flexible floor unit acts as a single, continuous lead barrier that covers critical parts of the body without exerting pressure.
Direct Flow Medical has announced it has received the CE Mark for an enhanced transfemoral delivery system for its transcatheter aortic valve implantation (TAVI) valve. It says that the system features a low profile, ultra-flexible sheath that, in addition to the non-metallic valve, allows for easy access and excellent trackability through calcified and tortuous anatomies.
Mitralign has reported on the successful use of its technology to perform a percutaneous repair on a patient with tricuspid regurgitation. The company also announced that Joachim Schofer (Medicare Center and Department for Percutaneous Interventions of Structural Heart Disease, Albertinen Heart Center, Hamburg, Germany) and Rebecca Hahn (director of Interventional Echocardiography, Columbia University Medical Center/New York Medical Center/New York Presbyterian Hospital, USA) presented details of the procedure at PCR London Valves (28–30 September, London, UK).
Data presented at PCR London Valves (28–30 September, London, UK) indicate that the Acurate Neo transfemoral (TF) transcatheter aortic valve implantation (TAVI) system, which recently received the CE mark, is not associated with any incidences of severe paravalvular leak. Additionally, the device is associated with a low mortality rate of 2.5%.
Heart disease is the leading cause of death worldwide, but it does not have to be. Reflecting on the World Heart Day theme, creating heart-healthy environments, ESC spokesperson professor Stephan Gielen from Halle, Germany pointed out that there are more cases of cardiovascular disease in India and China than in all developed countries together.
Raffaele Piccolo (Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy) and others report in The American Journal of Cardiology that, according to the findings of a network meta-analysis, both drug-eluting balloons and drug-eluting stents represent valid treatment options for patients with drug-eluting stent restenosis. However, they claim that balloon angioplasty is not an effective treatment option and should not be used.
Efforts over the past decade to improve the quality of care for cardiovascular disease patients and increase the use of evidence-based treatments have led to a significant drop in the rate of hospitalisations and deaths, according to a new study released in the journal Circulation. The results are welcome news and emphasise the value of recent efforts by the cardiovascular community to support the delivery of timely, high-quality care to patients. This news also underscores the need to remain committed to efforts to improve outcomes and access to appropriate heart disease care.
A new study shows a strong association between severe, untreated obstructive sleep apnoea and the risk of elevated blood pressure despite the use of high blood pressure medications.
Boehringer Ingelheim has announced that the first patients have been enrolled in the company’s new international phase III study, RE-DUAL PCI. The study will evaluate the efficacy and safety of the oral anticoagulant dabigatran etexilate in patients with non-valvular atrial fibrillation, who have undergone a percutaneous coronary intervention (PCI) with stent placement to widen their blocked coronary arteries.
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