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.
Data from the Italian National Registry indicate that hypertension provides a protective effective against early cerebrovascular events after transcatheter aortic valve implantation (TAVI). The variable also shows a tendency to protect against late events
A study has indicated that percutaneous edge-to-edge mitral valve repair with the MitraClip (Abbott Vascular) can be performed safely and effectively, in experienced centres, in both patients with central degenerative mitral regurgitation and those with non-central degenerative mitral regurgitation
PLC Systems reports that the first patient has been treated in a study designed to evaluate the effectiveness of its RenalGuard therapy for preventing acute kidney injury in patients undergoing transcatheter aortic valve implantation.
Cardiological Solutions has announced that it has been granted two additional patents for its family of aortic embolic protection devices, which are designed to prevent stroke and other ischaemic complications. The new patents include its first issued patent for its Emboline Cap technology and a further patent for its broad embolic deflector intellectual property portfolio.
Six-month results from the first 60 patients in the REPRISE II study show that Boston Scientific’s transcatheter aortic valve implantation (TAVI) device (Lotus) is not associated with any new cases of valve-related adverse events between 30 days and six months. The data won Best Abstract 2013 at PCR London Valves (15–17 September, London, UK).
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