Neovasc has enrolled the first patient in the European arm of its TIARA-I early feasibility trial, a multinational, multicentre trial being conducted at centres in the USA, Europe and Canada to assess the safety and performance of Neovasc’s Tiara mitral valve system and implantation procedure in high-risk surgical patients suffering from severe mitral regurgitation.
In a new consensus statement, the Joint UK Societies claim that the negative results of SYMPLICITY HTN-3 should not be used as a “rationale for abandoning” renal denervation as a “novel therapeutic development” for resistant hypertension because they claim more clinical trials are needed to evaluate the safety and efficacy of the therapy.
REVA Medical has initiated patient enrollment with its Fantom bioresorbable drug-eluting scaffold.
Three studies presented at the 2014 European Association for Cardio-Thoracic Surgery annual meeting (11–15 October, Milan, Italy) showed, respectively, that Sorin’s sutureless Perceval aortic valve is associated with excellent haemodynamic results at 30 days, no valve migration at five years, and a lower use of resources than traditional valves. Positive data for the company’s Freedom Solo stentless aortic valve were also presented at the conference.
Ablative Solutions has announced that the first patient in the Peregrine Study has been treated with company’s the investigational Peregrine system, which delivers agents directly to the sympathetic-nerve-laden peri-adventitial area of the renal artery to perform chemical neurolysis. Wojtek Wojakowski is the principal investigator of the study, and the patient has now been discharged from the hospital.
Boston Scientific has initiated a new study of its second-generation everolimus-eluting coronary stent (Promus Premier) to evaluate its use in the management of coronary artery disease in in under-served patient populations, including women, African Americans, Latinos/Hispanics, Native Americans and Alaska Natives.
Merit Medical has announced that it has launched a new website and educational initiative (thinkradial.com). The aim is to provide specialised training courses and information to help interventional cardiologists master the skills necessary to ensure successful radial access. The radial approach has grown in popularity with up to 90% adoption in some parts of the world, but uptake has been slower in the USA.
Neovasc has received FDA conditional approval to initiate its TIARA-I Trial in the USA. The multinational, multicentre early feasibility trial will evaluate the safety and performance of the company’s Tiara mitral valve system and implantation procedure in high-risk surgical patients with severe mitral regurgitation.
Salvatore Cassese (Deutsche Herzzentrum, Technische Universität and DZHK, partner site Munich Heart Alliance, Munich, Germany) and others report in the European Heart Journal that the four-year mortality rate is significantly higher in patients with evidence of restenosis at routine control angiography than patients without evidence of restenosis. They add that the rate is significantly increased even in restenosis patients who are asymptomatic.
Sorin Group announced CE mark certification for its new MEMO 3D ReChord mitral valve annuloplasty ring that is now commercially available in Europe. The first implant was presented at the 28th Annual Meeting of the European Association for Cardiothoracic Surgery (EACTS) by Mattia Glauber.
The National Institute for Health and Care Excellence (NICE) issued its appraisal consultation document (ACD) recommending Xarelto (rivaroxaban) 2.5mg twice daily as an option for secondary prevention in acute coronary syndrome.
In an analysis that included approximately 35,000 participants, genetic predisposition to elevated low-density lipoprotein cholesterol (LDL-C) was associated with aortic valve calcium and narrowing of the aortic valve, findings that support a causal association between LDL-C and aortic valve disease, according to a study appearing in JAMA. The study is being released to coincide with its presentation at the Canadian Cardiovascular Congress.
TransMedics has announced that its Organ Care System (OCS) heart technology was used to perform the world’s first series of adult human heart transplants from donors after circulatory death (DCD donors) at St Vincent’s Hospital in Sydney, Australia.
Every doctor in the USA can now provide patient care virtually anytime and from anywhere. The new HealthTap Concierge enables doctors to connect privately with their own patients via HD video or secure text, and conduct paid consults at their convenience.
Stentys has announced it received CE marking for its sirolimus-eluting stent. The CE marking will allow the company to market its sirolimus-eluting stent in Europe immediately and, starting in 2015, in the other countries where the company has commercial activity.
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