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).
Following approval from the FDA, Medtronic has launched the Export Advance aspiration catheter in the USA. The device, which has been designed to remove thrombus from the coronary arteries, features a pre-loaded stylet.
Medtronic has announced that it will unveil results, in a late-breaking trial session on Tuesday 29 October, from its Extreme Risk study of the CoreValve US Pivotal Trial at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference (27 October–1 November, San Francisco, USA).
According to M Zeeshan Khawaja (The Rayne Institute, King’s College London & St Thomas’ Hospital, London, UK), transcatheter aortic valve implantation (TAVI) is not contraindicated in patients with significant mitral regurgitation because more than half of patients with the condition saw an improvement in mitral regurgitation grade after undergoing TAVI.
Therox has announced that data from an Investigational Device Exemption (IDE) pilot study of its next-generation supersaturated oxygen (SSO2) therapy will be presented at the upcoming 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium (27 October–1 November, San Francisco, USA).
Biotronik has announced that the first patient, as part of a clinical study, has been treated with its bioresorbable magnesium Dreams scaffold. BIOSOLVE-II is a prospective, multicentre clinical trial evaluating the safety and efficacy of an improved design of Dreams.
Micell Technologies announced on 8 October that a peer-reviewed article discussing imaging and clinical results of the DESSOLVE I trial of its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES) was accepted for publication on the JACC: Cardiovascular Interventions website.
Northwestern’s Bluhm Cardiovascular Institute has enrolled its first participant in SALUS, a clinical trial studying the effectiveness of a prosthetic aortic heart valve that can be placed without open-heart surgery.
Trophos has announced the final patient completion of a phase II study of TR040303 in patients treated for acute myocardial infarction. Outcome data of this study is expected to be available towards the end of 2013.
After receiving CE mark approval for its Xlimus drug-eluting stent, Cardionovum has initiated the international (outside of the USA) market launch of the stent. The stent is coated with the antiproliferative drug sirolimus and uses a fully biodegradable PLLA (Polylactid) drug release matrix.
Endocross announced, on 1 October, that it has already enrolled one-third of the patients planned for the first-in-human study of its Enabler-C Catheter System for crossing coronary chronic total occlusions (ENABLER 3C study). The study is taking place at the Institut Cardiovasculaire Paris-Sud under principal investigator Yves Louvard.
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