Experience and improved patient selection have improved outcomes with transapical aortic valve implantation in the PARTNER trial Non-Randomized Continued Access (NRCA) programme, new results have shown. Improvement was seen in the rates of death, stroke and bleeding in the NRCA patients compared to those enrolled in the randomised PARTNER trial Cohort A, Todd M Dewey told delegates at The Society of Thoracic Surgeons (STS) Annual Meeting in Fort Lauderdale, USA.
Since time that the FAST trial1 was designed in 2007, up to now, there has not been clear evidence to indicate ablation treatments aside from the control of symptoms.2,3 Nevertheless, catheter ablation has expanded its indications thanks to increasing evidence that it is significantly more effective at maintaining sinus rhythm than drug therapy. The expanded indication of catheter ablation has been reflected in the 2011 ACC/AHA/ESC guidelines.3
A sub-analysis of data from the ROCKET-AF trial shows that rivaroxaban (Xarelto, Bayer Healthcare) might be better at preventing clot-related strokes in patients with atrial fibrillation while minimising the risk of causing a bleeding stroke. The research was presented at the American Stroke Association’s International Stroke Conference 2012.
Boston Scientific announced first patient use and European market launch of the Promus Element Plus everolimus-eluting platinum chromium coronary stent system. The first patient implant in Europe using the new device was performed by Antonio Colombo, director of the Cardiac Catheterization Laboratory at Columbus Hospital and San Raffaele Hospital in Milan, Italy. The new stent system incorporates the platinum chromium (PtCr) alloy and stent design of the Promus Element stent with an enhanced catheter delivery system engineered for improved deliverability in treating patients with coronary artery disease.
Bristol-Myers Squibb and Pfizer have announced that the US Food and Drug Administration (FDA) has extended the action date by three months for the new drug application for apixaban (Eliquis) for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The new prescription drug user fee act goal date is 28 June 2012.
The Parachute is a catheter based partitioning device deployed within the left ventricle for patients who have developed ischaemic heart failure following a heart attack. This implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle.
UPDATED APPROPRIATE USE CRITERIA FOR CORONARY REVASCULARIZATION. JANUARY – FEBRUARY 2012 VOL. 41, NO. 1
Discovery CT750 HD (GE Healthcare) has been included in the first fully positive recommendation from UK’s National Institute for Health and Clinical Excellence (NICE)’s Diagnostic Assessment Programme which aims to ensure the National Health Service (NHS) can rapidly and consistently adopt clinically and cost effective technologies.
Data presented at the Society of Thoracic Surgeons (STS) 48th Annual Meeting (Fort Lauderdale, USA, 28 January–1 February) demonstrate positive outcomes when the CoreValve system (Medtronic) is implanted using the direct aortic approach. This approach received CE mark in .ovember 2011 and is also being evaluated in the Medtronic CoreValve US pivotal trial.
A minimally invasive surgical approach to transcatheter aortic valve implantation (TAVI) that goes directly through the aorta is associated with low rates of mortality and complications, according to two late-breaking clinical trial presentations here.
Percutaneous coronary intervention with a drug-eluting balloon for instent restenosis is a promising effective therapeutic option with an unexpected low repeat restenosis and target lesion revascularisation rate, according to research presented at the American Heart Association’s Scientific Sessions 2011.
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced today that an interim analysis of the FAME II trial has found a highly statistically significant reduction in the need for hospital readmission and urgent revascularization when Fractional Flow Reserve (FFR)-guided assessment was used to direct treatment in patients with coronary artery disease. As a result of the positive interim analysis, the FAME II independent Data Safety Monitoring Board (DSMB) has recommended investigators stop patient enrollment in this trial as the DSMB considers it unethical to continue to randomize patients to optimal medical therapy (OMT) alone.
Volcano Corporation (NASDAQ: VOLC), a leading developer and manufacturer of precision intravascular diagnosis and therapy guidance tools designed to enhance the treatment of coronary and peripheral artery disease, said today it expects total revenues for the fourth quarter of 2011 will be approximately $92.7 million , bringing expected full year 2011 revenues to approximately $343.5 million.
On 8 December, Abbott announced the initiation of ABSORB II, the first randomised, controlled, multicentre clinical trial to evaluate the safety, efficacy and performance of the Absorb bioresorbable vascular scaffold (BVS) compared to Abbott’s Xience Prime everolimus eluting coronary stent system.
Four-year results from the LEADERS trial show that BioMatrix Flex, Biosensors’ Biolimus A9-eluting stent system with a biodegradable polymer coating, significantly reduces the risk of very late stent thrombosis compared to that of a drug-eluting stent system with a durable polymer coating.
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