Royal Sussex County Hospital, Brighton, UK, has enrolled the first patient in the United Kingdom for the Gore REDUCE clinical study of patent foramen ovale closure. David Hildick-Smith, director of Cardiac Research Unit, Brighton and Sussex University Hospitals and study investigator, performed the first procedure.
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.
JenaValve Technology has announced that the company has received CE mark approval for its transapical transcatheter aortic valve implantation (TAVI) system of the second generation.
Baxter has announced that it has started a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischaemia.
Biosense Webster has announced that a study it is sponsoring, the Atrial Fibrillation Progression Trial (ATTEST), has started to enrol patients and will investigate the impact of early radiofrequency ablation on the progression of drug-refractory paroxysmal atrial fibrillation to persistent atrial fibrillation.
Draft guidance from NICE’s Diagnostics Assessment Programme on four new generation cardiac computed tomography (CT) scanners has been issued for public consultation. The provisional recommendations support the use of Somatom Definition Flash CT scanner (Siemens AG Healthcare), Aquilion ONE (Toshiba Medical Systems), Brilliance iCT (Philips Healthcare) and Discovery CT750 (GE Healthcare) in the NHS in England for people with suspected or known coronary artery disease in whom imaging is difficult with earlier generation CT scanners.
Boston Scientific reported positive long-term data from the PERSEUS clinical programme, which demonstrated favorable two-year safety and effectiveness outcomes for the ION (TAXUS Element) Paclitaxel-Eluting Platinum Chromium stent system used in coronary artery disease versus prior-generation paclitaxeleluting stents.
Paul S Teirstein, Scripps Clinic La Jolla, California, USA, presented positive clinical endpoint data from the PLATINUM Long Lesion trial at the Cardiovascular Research Foundation’s annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium (San Francisco, USA, 7−11 November 2011).
Medtronic announced on 17 February 2012 FDA approval of the Resolute Integrity drug-eluting stent for the treatment of coronary artery disease. The new heart device’s FDA approval stems from the results of a global series of studies involving the Resolute drug-eluting stent, which showed consistently powerful clinical performance across a broad spectrum of patients––including those with diabetes. The Resolute Integrity uses the same drug-and-polymer combination as the Resolute device.
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.
A study published online in the HeartRhythm Journal indicates that while the sodium channel blocker test has good prognostic value in symptomatic patients with non-diagnostic Brugada ECG (Br-ECG), it appears to have little value in asymptomatic patients.
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.
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.
A fully biodegradable stent was safe over the course of a decade-long study, researchers reported. In a single-institution study, major complication rates among 50 patients treated with Igaki-Tamai stents were similar to those seen with metal stents, according to Kunihiko Kosuga, MD, PhD, of Shiga Medical Center for Adults in Moriyama City, Japan, and colleagues.
In the aftermath of several high-profile cases of "overstenting," the Maryland General Assembly has passed legislation establishing an independent review process to ensure the medical necessity of coronary stent placement.
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