St Jude Medical has announced a new data analysis from the CHAMPION clinical trial—in a subgroup of patients with renal failure—that showed reduced heart failure hospitalisation by 42% for patients managed with pulmonary artery pressure based technology compared to a control group. Renal function was not adversely affected.
CLEAN-TAVI, which was presented at TCT this morning, indicates that the use of Claret Medical’s dual filter cerebral protection system (Montage) during transcatheter aortic valve implantation (TAVI) is associated with a significant reduction in the number of cerebral lesions after TAVI.
Medtronic has announced the US Food and Drug Administration (FDA) 510(k) clearance and launch of the NC Euphora noncompliant balloon dilatation catheter. The new device will be featured for the first time in the United States at the Medtronic booth at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) meeting (13–17 September, Washington, DC, USA).
Shockwave Medical announced positive clinical results from the DISRUPT PAD study evaluating the safety and utility of Lithoplasty balloon catheters for the treatment of peripheral artery disease, at the Vascular Interventional Advances (VIVA) Annual Conference in Las Vegas, USA.
Cardinal Health has announced that its MynxGrip Vascular Closure Device recently received Food and Drug Administration (FDA) approval for use to close femoral veins. The MynxGrip device is now indicated for use to seal 5F, 6F and 7F femoral arterial and femoral venous access sites
Retrospective data analysis from the CHAMPION clinical trial shows significant reduction in 30-day hospital readmission rates for heart failure patients age 65 and older treated with the CardioMEMS HF system (St Jude Medical). The trial looked at the safety and effectiveness of the device for patients with New York Heart Association (NYHA) Class III heart failure who had been hospitalised for heart failure in the previous 12 months.
In the first successful US pivotal trial of a bioabsorbable polymer stent, the Boston Scientific everolimus-eluting bioabsorbable polymer platinum chromium coronary stent system met its primary endpoint in this non-inferiority study, which evaluated the one-year rate of target lesion failure (TLF).
BioCardia has received permission to begin a phase III clinical trial of its bone marrow-derived CardiAMP therapy for heart failure after clearance from the US Food and Drug Administration (FDA). The clinical trial is a randomised, controlled, multicentre study of 250 patients evaluating CardiAMP therapy at up to 40 clinical sites.
Qvanteq AG has enrolled the first patient in the First in Man clinical study QUEST I, following earlier regulatory approval from the Dutch and Swiss authorities. The aim of the QUEST I study is to assess feasibility and safety of the Qstent, a bioactive, coating-free coronary stent. The Qstent has shown excellent in-growth and low thrombogenicity in pre-clinical studies.
Baylis Medical has announced the official opening of its new office in Watford, UK, on the outskirts of London. The company says that the opening of the Watford office is a part of its European expansion project.
The US Food and Drug Administration has cleared the marketing of the HeartFlow FFR-CT software, which permits health care professionals to non-invasively evaluate blood flow in the coronary arteries of patients showing signs and symptoms of coronary artery disease.
A study presented at the AHA Scientific Sessions looks at the risks and benefits of continuing dual antiplatelet therapy beyond one year after placement of one or more drug-eluting stents as compared with aspirin therapy alone.
Toshiba America Medical Systems’ Dose Tracking System (DTS) was awarded the Innovative Technology designation by Novation at its Innovative Technology Expo.
Annetine Gelijins (Department of Population Health Science and Policy, Icahn School of Medicine, Mount Sinai, New York, USA) and others report in The New England Journal of Medicine that mitral valve repair alongside coronary artery bypass grafting (CABG) does not reduce left ventricular reverse remodelling compared with CABG alone at one year in patients with multivessel disease and moderate functional mitral regurgitation. The combined procedure also doesnot reduce major adverse cardiac or cerebrovascular events compared with CABG alone.
Royal Philips has introduced the DoseWise Portal, a comprehensive radiation dose management software solution aimed at managing radiation exposure risk to patients and their caregivers.
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