Medtronic, Inc. (NYSE: MDT) has announced the highly anticipated results from the CoreValve U.S. Pivotal Trial, the first U.S. data presented on the Medtronic CoreValve® System. The study of the novel self-expanding device, presented at a late-breaking clinical trial session of the Transcatheter Cardiovascular Therapeutics (TCT) 2013 Conference, met its primary endpoint in patients who were considered too ill or frail to have their aortic valves replaced through traditional open-heart surgery, with a rate of death or major stroke at one year of 25.5 percent. This result is highly significant (p<0.0001) as it was 40.7 percent lower in patients treated with the CoreValve System than was expected with standard therapy (a pre-specified performance goal of 43.0 percent).
A clinical trial designed to measure the effectiveness of using a dedicated side branch-covering bare metal stent in true bifurcation coronary lesions found that that the strategy was safe, but the results did not establish non-inferiority compared to the currently accepted strategy of using a single stent with provisional use of a second side branch stent when indicated.
Volcano Corporation announced final results of ADVISE (Adenosine vasodilator independent stenosis evaluation) II, a prospective, double-blind, global, multicentre registry designed to investigate the diagnostic utility of the Instant Wave-Free Ratio (iFR) Modality in assessing the severity of coronary stenosis.
Treatment with MitraClip has shown clinically meaningful changes to quality of life, a reduction in rehospitalisation for heart failure, and functional improvements for patients with degenerative mitral regurgitation who are at prohibitive risk for mitral valve surgery, it states in a company press release.
In a clinical trial, a self-expanding transcatheter aortic valve met the key performance objective of reducing death and stroke in patients with severe aortic stenosis at extreme risk for surgery. Results of the COREVALVE EXTREME RISK trial were presented at the 25th 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.
OrbusNeich has announced that new clinical data presented at 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium show durable outcomes as well as excellent early healing and optimal neointimal suppression out to 24 months following placement of the Combo dual therapy stent.
Biotronik Japan has announced enrolment of the first patient in the BIOFLOW-IV study, which aims to verify the efficacy and safety of the Orsiro Hybrid drug-eluting stent. The high quality and efficacy of Orsiro has already been confirmed by three important trials, BIOFLOW-I, -II, and –III, which demonstrated the safety and efficacy of Orsiro.
Juventas Therapeutics announced today that the company has completed enrolment of the STOP-HF trial. STOP-HF is a double-blinded, placebo-controlled, multi-centre trial of its non-viral DNA plasmid therapy JVS-100 for patients with symptomatic heart failure.
Royal Philips and RealView Imaging have announced that they have completed a clinical study that has demonstrated the feasibility of using an innovative live 3D holographic visualisation and interaction technology to guide minimally-invasive structural heart disease procedures.
St Jude Medical announced positive results for the 23–25mm Portico Transcatheter Aortic Heart Valves in the Portico Transfemoral CE mark trial (Portico TF CE Trial).
Boston Scientific has received CE mark for the Lotus Valve System, the company’s advanced transcatheter aortic valve implantation (TAVI) technology. This key approval offers a treatment alternative for patients with severe aortic stenosis who are high risk for surgical valve replacement.
Abbott Vascular has announced that it will immediately launch the MitraClip, which is a minimally invasive device for the management of significant symptomatic degenerative mitral regurgitation in patients who are at prohibitive risk for mitral valve surgery, on to the USA market now that it has received FDA approval for the device.
Predicting the chances of someone developing a disease is not an exact science, but researchers from Pittsburgh say comparing the ratio of harmful factors with protective ones may give a more accurate picture.
Cardiovascular Systems announced that it has received approval from the US Food and Drug Administration (FDA) to market its Diamondback 360 Coronary Orbital Atherectomy System (OAS) as a treatment for severely calcified coronary arteries.
Stentys has announced that four-month data from its APPOSITION IV study, for its self-apposing stent, will be presented at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference next week (27 October–1 November, San Francisco, USA).
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