España, octubre de 2012.- Daiichi Sankyo Company, Limited ha anunciado que ha completado el reclutamiento de pacientes para el estudio global de fase 3, Hokusai-VTE. La investigación analiza el papel del inhibidor oral del factor Xa de toma única diaria edoxabán en el tratamiento y prevención de la recurrencia de tromboembolismo venoso (TEV), en pacientes que han padecido una trombosis venosa profunda (TVP) sintomática y aguda, embolia pulmonar (EP) o ambos.1,2
Twelve-month results from the DELUX registry demonstrating excellent safety and efficacy for the Pantera Lux Paclitaxel Releasing Balloon in 1,064 patients were presented by Gert Richardt, Segeberger Heart Center Clinic, Germany, and Christoph K Naber, Elisabeth Hospital, Germany, at the Transcatheter Cardiovascular Therapeutics congress in Miami, USA.
On 29 October 2012, Maquet Cardiovascular announced that it has received 510(k) clearance from the FDA and CE mark approval for its new Sensation Plus 7.5F 40cc intra-aortic balloon catheter. This new larger-volume, fibre-optic intra-aortic balloon catheter will allow clinicians to provide a higher-efficacy, faster intra-aortic balloon counterpulsation therapy to smaller patients – those who are 5’0” to 5’4” tall (152–162cm). It will be available for sale in the United States and in the European Union in October.
St Jude Medical has announced results from its RESPECT trial, which studied the Amplatzer PFO Occluder in the prevention of recurrent cryptogenic stroke. Evidence presented at a late breaking trial session during the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, shows that the primary analysis was not statistically significant but trended towards superiority, while additional analyses demonstrated superiority. Stroke risk reduction was observed across the totality of analyses with rates ranging from 46.6– 72.7%.
Results from the EXCELLA II randomised trial presented at TCT 2012 have shown lower re-intervention rates with the DESyne Novolimus Eluting Coronary Stent System compared with the Endeavor zotarolimus-eluting system.
A clinical trial indicates that using an investigational medical device to close a PFO, or "hole in the heart," may be superior to medical management alone in the prevention of a repeated stroke. Results of the RESPECT trial were presented today at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF)
A clinical trial that compared catheter-based PFO closure using an investigational device found that there was no significant reduction in ischemic and bleeding events compared to standard medical therapy; stroke risk was non-significantly reduced with device therapy. The PC Trial was presented at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world s premier educational meeting specializing in interventional cardiovascular medicine.
The MGuard Embolic Protection Stent (EPS) (InspireMD) was shown to be significantly superior when compared to standard bare metal and drug eluting stents in achieving complete ST resolution and restoring normal blood flow. According to results from the MASTER trial presented by Gregg W Stone and director of the Cardiovascular Research and Education Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center, at a Late Breaking Trials Sessions at TCT.
Contrary to previous data, STEMI patients with prior open heart surgery, or coronary artery bypass graft surgery (CABG) and receive a coronary stent have similar outcomes to patients without previous CABG, based on study of a large, prospective, regional STEMI network, presented at TCT.
Boston Scientific has received European approval to update the directions for use (DFU) labeling for Promus Element and Promus Element Plus Coronary Stent Systems to include three-month dual anti-platelet therapy (DAPT).
A semi-structured survey suggests that more than 15% of patients suffering from severe symptomatic aortic stenosis eligible for transcatheter aortic valve implantation (TAVI) did not receive the treatment for budget-related reasons in 2011.
A strategy of up-front percutaneous coronary intervention (PCI) for lesions confirmed to be obstructive by fractional flow reserve (FFR) was shown to be cost-effective in terms of quality-adjusted life years when compared to medical therapy alone. Results of the Cost-Effectiveness sub study of the FAME 2 trial were presented at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world s premier educational meeting specializing in interventional cardiovascular medicine.
A study found that second-generation drug-eluting stents are safe and effective in the treatment of left main coronary artery lesions. Results of the ISAR-LEFT MAIN 2 trial were presented at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world s premier educational meeting specializing in interventional cardiovascular medicine.
SAN DIEGO, Oct. 25, 2012 /PRNewswire/ -- Volcano Corporation (NASDAQ: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced that St. Jude Medical agreed that previous versions of its PressureWire® products infringed Volcano s 6,976,965 patent (a pressure sensing guide wire patent). Proceedings on damages have not yet been scheduled. In addition, a jury in the federal district court in Delaware has issued a verdict in St. Jude Medical s favor with respect to Volcano s patents at issue in the Company s ongoing patent lawsuit with St. Jude Medical, finding that St. Jude Medical s PressureWire® products do not infringe three of Volcano s patents.
Volcano has announced the global launch of the PrimeWire Prestige Plus pressure guidewire with AcuSense technology, which allows for more precise measurements when distal pressure is monitored for longer periods of time.
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