Nearly 50% of patients suffering from a diseased mitral heart valve with severe, symptomatic regurgitation are currently denied open-heart surgery because it is considered too risky. In the future, percutaneous transcatheter mitral valve implantation (TMVI) may offer new hope for these patients.
The Medicines Company has announced the approval of Kengreal (cangrelor) by the US Food and Drug Administration (FDA) as an adjunctive therapy to percutaneous coronary intervention (PCI) for reducing periprocedural thrombotic events in patients who have not been treated with a P2Y12 inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor (GPI).
Corindus Vascular Robotics has announced that a complex percutaneous coronary intervention (PCI) was broadcast live to attendees of the 2015 Complex Cardiovascular Catheter Therapeutics Conference (C3 Conference; 14–18 June, Orlando, USA).
Vascular Solutions has launched two new versions of its Turnpike catheters for use in complex coronary and peripheral interventions. The original version of Turnpike was introduced in January 2015, and now Vascular Solutions has added the Turnpike Spiral and Turnpike Gold versions to the product line.
The first US patient—Biotronik has revealed—has been enrolled in the BIOFLOW-V clinical study of the Orsiro hybrid drug-eluting stent. The aim of the study is further demonstrate the safety and effectiveness of the device. The implant of the stent was successfully performed by David Trice at Thomas Hospital in Fairhope, Alabama, USA.
Edwards Lifesciences has announced that the FDA has approved its latest transcatheter aortic valve implantation (TAVI) system—Sapien 3—for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis. According to a press release, the Sapien 3 valve builds on Edwards’ decades of experience in the development of tissue heart valves and the proven benefits of the existing Sapien valves.
Randomised controlled trials must be simplified to sustain innovation in cardiovascular diseases, which are still the biggest killer in Europe, according to the Cardiovascular Round Table (CRT), an independent forum established by the European Society of Cardiology (ESC) and comprised of cardiologists and representatives of the pharmaceutical, device and equipment industries. The group’s views have been published in the European Heart Journal.
A study evaluating the Boston Scientific Lotus valve system has demonstrated a low rate of paravalvular aortic regurgitation for a transcatheter aortic replacement valve, plus a cardiovascular mortality rate of less than 2% at 30 days.
Adding the HeartFlow FFRCT Analysis to a standard coronary computed tomography (CT) angiogram (cCTA) may change the course of treatment in more than one third of patients with coronary artery disease, according to a study presented at EuroPCR 2015 (19–22 May, Paris, France). Results of the FFRCT RIPCORD study, presented by Nick Curzen of the University Hospital Southampton, UK, further reinforces the ability of the HeartFlow Analysis to aid in patient management.
OrbusNeich has announced that the first US patient has been enrolled in the HARMONEE (Harmonised assessment by randomised, multicentre study of OrbusNeich’s COMBO stent) study. The study is being conducted under the framework of the joint Japan-USA “harmonisation-by-doing” (HBD) initiative and will support the company’s planned application for Shonin approval in Japan and to meet the feasibility trial requirements in the USA.
There is a striking and statistically significant difference in how women and men are treated following a heart attack. These gender differences are reflected in the rate of risk factor control, which was lower in women, and in the rate of hospital readmission for a further heart attack, which was higher in women than in men.
Direct Flow Medical has announced positive two year data from the DISCOVER CE mark trial studying its Transcatheter Aortic Valve System at EuroPCR 2915 (19–22 May, Paris, France). Demonstrating good patient outcomes with few complications, the two-year data were presented by Antonio Colombo, from the Ospedale San Raffaele in Milan, Italy.
Presented as a late-breaking clinical trial at EuroPCR (19–22 May, Paris, France), new two year results from the NOTION trial showed that transcatheter aortic valve implantation (TAVI) with CoreValve is as safe and effective as surgery in patients that are at a low- or intermediate-risk for surgery.
Biotronik has announced the completion of the BIOVALVE first-in-human trial for its new transcatheter aortic valve. Study doctors successfully implanted the device in patients suffering from severe symptomatic aortic stenosis. The study, which established the transcatheter aortic valve implantation (TAVI) device’s early safety at 30 days, was conducted at the University Heart Center Hamburg-Eppendorf (UKE), Germany.
Boston Scientific has reported positive, long-term data from the EVOLVE Trial of the Synergy everolimus-eluting bioabsorbable polymer platinum chromium coronary stent system, with no new major adverse cardiac events reported between years three and four. The study results were presented for the first time at EuroPCR 2015 (19–22 May, Paris, France) by Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia.
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