Stefan Verheye (Antwerp Cardiovascular Centere ZNA Middelheim, Interventional Cardiology, Antwerp, Belgium) and others report in JACC: Cardiovascular Interventions that the use of a sirolimus-coated balloon (Virtue, Caliber Therapeutics) to treat in-stent restenosis in patients with a bare metal stent/drug-eluting stent is associated with “excellent” procedural outcomes and a similar rate of late lumen loss as existing non-stent in-stent restenosis options.
The independent Data Safety Monitoring Board (DSMB) has found no significant safety concerns with BioCardia’s CardiAMP trial results. It recommends that the study continue as planned.
The US Food and Drug Administration (FDA) has approved Medtronic’s HeartWare HVAD system as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants.
Gore has completed enrolment for the pivotal phase of its Gore ASSURED Clinical Study. This investigational device exemption (IDE) trial is researching the company’s Cardioform ASD Occluder for the interventional closure of atrial septal defects, sized 8mm to 35mm.
The US Food and Drug Administration (FDA) has accepted TherOx’ Premarket Approval (PMA) application for its Supersaturated Oxygen (SSO2) Therapy system.
Spectranetics has recalled the Bridge occlusion catheter “due to the possibility of a blocked guidewire lumen in some device units”. Using affected catheters could lead to the incorrect positioning of the device and subsequent uncontrolled haemorrhage.
Saranas has announced the appointment of Philippe Généreux as its chief medical officer. Généreux is the co-director of the Structural Heart Disease Program at Morristown Medical Center, Morristown, USA. Saranas’ lead product is its Early Bird bleed detection system, which – press release reports – is moving through final product testing. FDA submission is expected later this year.
The American College of Cardiology (ACC) and the American Heart Association (AHA) have released updated clinical performance and quality measures to benchmark and improve the quality of care for adult patients hospitalised with ST-elevation and non–ST-elevation myocardial infarction (STEMI and NSTEMI, respectively).
iVascular SLU has received approval for selling its coronary and peripheral products in India. Therefore, the company’s coronary drug-eluting stent, coronary dug-coated balloon, as well as its peripheral drug-coated and stents are now available for sale on the Indian subcontinent.
A new post-market clinical study is to evaluate Medtronic’s CoreValve Evolut Pro transcatheter aortic valve implantation (TAVI) valve in everyday clinical practice. Studying patients with severe symptomatic aortic stenosis at an intermediate, high or extreme risk for open heart surgery, the FORWARD PRO clinical study will evaluate longer term performance (out to five years) of the next-generation self-expanding TAVI system.
Abiomed has received FDA pre-market approval for its Impella RP heart pump. Culminating from five years of research, according to a press release, this approval follows the prior FDA hmanitarian device exemption (HDE) received in January 2015 and adds the Impella RP heart pump to Abiomed’s platform of PMA-approved devices.
The results of CLOSE, Gore Reduce and the extended follow-up of RESPECT—all published in The New England Journal of Medicine—indicate that percutaneous closure of patent foramen ovale (PFO) is associated with a significant reduction in ischaemic stroke in patients with prior cryptogenic stroke. However, two of the studies indicate that closure is also associated with an increased risk of atrial fibrillation.
Dragana Radovanovic (AMIS Plus Data Centre, Zurich, Switzerland) and colleagues report in the European Heart Journal: Acute Cardiovascular Care that the treatment of myocardial infarction depends on a patient’s history of cancer.
A new scanning device designed to aid cardiac ‘rule out’ is to be exhibited at the EUSEM European Society of Emergency Medicine conference (EUSEM; 23–27 September, Athens, Greece). The Creavo Medical Technologies’s Vitalscan uses magnetocardiography to help physicians rule out significant cardiac conditions such as heart attacks in patients presenting to emergency departments with chest pain.
According to a new survey, the average age and income of cardiologists in the US are increasing.
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