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NOTICIAS


21 marzo 2013

FDA votes that the benefits of MitraClip outweigh the risks

Cardiovascular News

Abbott Vascular has announced that the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted five to three that the benefits of its MitraClip system for the management of mitral regurgitation outweigh its risks. However, the panel also voted five to four that there was not a reasonable assurance of the device’s efficacy.

25 marzo 2013

Positive outcomes for Promus Element in Platinum China study

Cardiovascular News

Boston Scientific has announced that the Platinum China study, which was presented at China Interventional Therapeutics (20–23 March, Beijing, China), indicated that the Promus Element stent is associated with a low rate of stent thrombosis at nine months. These data support the existing safety and efficacy data for the stent.

05 marzo 2013

Medtronic, Inc. (MDT) Scores Regulatory Approval to Update CE Mark for Drug-Eluting Stent

Bio Space

Of relevance to the clinical practice of interventional cardiology, Medtronic, Inc. (NYSE: MDT) announced today that it has received regulatory approval to update the CE (Conformité Européenne) mark labeling for the Resolute Integrity drug-eluting stent with new information on one month of dual antiplatelet therapy (DAPT), the shortest minimum duration referenced on the label for any device of its kind.

04 marzo 2013

Boston Scientific Corporation (BSX) Schedule of Major Presentations at the American College of Cardiology 2013

PRNewswire

Boston Scientific Corporation (NYSE: BSX) is scheduled to present sponsored research at the 62nd Annual Scientific Session of the American College of Cardiology which takes place March 9-11 in San Francisco, California. The clinical presentations will provide new insights on Boston Scientific research in cardiovascular disease, including aortic valve disease and atrial fibrillation.

09 febrero 2013

UK´S NICE issues draft guidance for acute management of STEMI

Cardiovascular News

The UK’s National Institute for Health and Clinical Excellence (NICE) has published the draft version of its guidance for the acute management of ST-segment-elevation myocardial infarction (STEMI) as part of its public consultation process The timeliness of primary percutaneous coronary intervention (PPCI) forms a key part of the draft guideline so commissioners and those delivering services for people with STEMI can plan their configuration in such a way that outcomes are optimal. This guideline also covers the use of antiplatelet and antithrombin agents, and improving outcomes for the minority of people still receiving fibrinolysis.

01 marzo 2013

CE mark for Engager TAVI system

Cardiovascular News

Medtronic has announced that, following CE mark approval, its Engager transcatheter aortic valve implantation (TAVI) system can now be used in patients with severe aortic stenosis who are high or extreme risk of surgery.

28 febrero 2013

Medtronic, Inc. (MDT) Reports CE Mark for Engager Transcatheter

Bio Space

Medtronic, Inc. (NYSE: MDT) today announced CE (Conformité Européenne) Mark of the Engager Transcatheter Aortic Valve Implantation (TAVI) System with transapical delivery catheter to treat patients with severe aortic stenosis who are at high or extreme risk for surgical aortic valve replacement (SAVR).

28 enero 2013

Biosensors International Receives CE Mark Approval for BioFreedom™

PRNewswire

BioFreedom represents the latest development in Biosensors stent technology, featuring a micro-structured abluminal surface which permits the controlled release of Biolimus A9™ (BA9™) without the use of a polymer. BA9 is a highly lipophilic anti-restenotic drug developed by Biosensors specifically for use with stents.

12 febrero 2013

Promus Premier Everolimus-Eluting Platinum Chromium Stent System receives CE mark approval

Cardiovascular News

On 12 February 2013, Boston Scientific received CE mark approval for its Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System, the company’s next-generation durable polymer drug-eluting stent technology, and has begun its European market launch. According to a company release, the Promus Premier Stent System is designed to provide physicians improved drug-eluting stent performance in treating patients with coronary artery disease. It is the only platform to feature a customised Platinum Chromium stent architecture, the market-leading Everolimus drug coating and fluorinated co-polymer, and an enhanced stent delivery system.

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