Data from the US CoreValve High Risk study show that the incremental costs of transcatheter aortic valve implantation (TAVI) with the CoreValve device (Medtronic) in patients at high risk for surgery compared with surgical aortic valve replacement are acceptable from a US perspective. However, the value of TAVI with CoreValve in a high-risk population would be high if the index admission costs of the procedure were reduced
Boston Scientific Corporation has initiated the REPRISE III clinical trial, which is US study to evaluate the safety and effectiveness of its transcatheter aortic valve implantation (TAVI) system—Lotus—in patients with severe aortic stenosis and who are considered to be at either high or extreme risk for surgical valve replacement. The Lotus is the first TAVI device that is both fully repositionable and retrievable prior to release.
The PRIMA (Percutaneous closure of patent foramen ovale in migraine with aura) study indicates that percutaneous closure of patent foramen ovale is associated with a significant reduction in migraine with aura days compared with medical therapy. However, it does not reduce total migraine days.
Somahlution announced on 22 September 2014 that it has received CE mark approval for DuraGraft, the first-in-class endothelial damage inhibitor (EDI) that uniquely protects vascular endothelium function and its associated architecture. DuraGraft, used as a vascular conduit solution, is a pivotal step in successful coronary artery bypass graft and peripheral bypass surgeries.
CardioKinetix has released results of a pooled analysis study of the first-of-its-kind catheter-based Parachute ventricular partitioning device. Twelve-month clinical data from PARACHUTE III, a study of 100 post-market European patients with ischaemic heart failure treated consecutively between 2011 and 2013, were presented at the 2014 TCT Conference in Washington, USA, by Ulrich Schäfer, (cardiology director of the Structural Heart Division at the Heart Center at the University Medical Center Hamburg-Eppendorf)
Svelte Medical Systems has reported that its drug-eluting coronary stent integrated delivery system (IDS), which is a new approach to percutaneous coronary intervention (PCI), met all DIRECT II study six-month angiographic and clinical endpoints. The system also exhibited reduced procedure and device times, with trends toward reduced fluoroscopy time and contrast use.
Micell Technologies has announced that positive three-year clinical results from the DESSOLVE I and DESSOLVE II trials of its Mistent sirolimus-eluting stent (SES) with a biodegradable polymer were presented at the Transcatheter Cardiovascular Therapeutics (TCT) meeting (13–17 September, Washington, USA). The MiStent SES is designed to optimise vessel healing in patients with coronary artery disease
According to results from the APPOSITION III study, which was presented at the Transcatheter Cardiovascular Therapeutics meeting (13–17 September, Washington, USA), the Stentys’ Self-Apposing stent is associated with a low rate of mortality at two years after a myocardial infarction. APPOSITION III is the largest trial ever conducted to evaluate the use of a self-apposing stent in primary percutaneous coronary intervention (PCI).
Stephen WL Lee (Queen Mary Hospital, Hong Kong) presented two-year optical coherence tomography (OCT) findings and three-year clinical follow up from the EGO COMBO study of Orbus Neich’s Combo dual therapy stent, which is the only drug-eluting stent with active EPC capture technology, at the Transcatheter Cardiovascular Therapeutics (TCT) meeting (13–17 September, Washington, USA). The data provided further evidence to support the healing benefits of the stent.
Cardiac Dimensions has announced that new long-term outcomes data from the TITAN II clinical trial of its enhanced Carillon mitral contour system showed significant and sustained improvements in mitral regurgitation, functional improvement, quality of life and reverse cardiac remodelling. The long-term safety and efficacy data, which was consistent with previous trials of the system, was presented at the recent Transcatheter Cardiovascular Therapeutics Conference (TCT) meeting (13–17 September, Washington, USA) by TITAN II investigator Michael Haude (Lukaskrankenhaus in Neuss, Germany).
New data from the Boston Scientific clinical trial programme of the Lotus transcatheter aortic valve implantation (TAVI) system continue to demonstrate strong performance with the device as a less invasive treatment for patients with severe aortic stenosis who are considered high risk for surgical valve replacement.
Symetis has received CE-mark approval for its transfemoral transcatheter aortic valve implantation (TAVI) system Acurate Neo, which means it now offers (like market leaders Medtronic and Edwards Lifesciences) both transapical and transfemoral options for TAVI delivery. The company has now launched the product with its first commercial implantations.
CeloNova BioSciences has announced that first-in-man clinical trial results found that its Cobra PzF coronary stent system, which has an advanced nano-thin coating of Polyzene-F polymer, is a safe and effective routine treatment for real-world and complex patients with heart disease. The stent was associated with a low rate of target vessel revascularisation (3%).
Abbott has announced positive one-year clinical results from ABSORB II, the world’s first prospective, randomised, controlled trial comparing the safety and effectiveness of the dissolving Absorb heart device to Abbott’s metallic Xience family of drug-eluting stents.
Five-year clinical outcomes for inoperable patients treated in the PARTNER trial, the world’s only prospective randomised trial for transcatheter aortic valve implantation (TAVI) in patients deemed too sick for open-heart surgery, were presented as part of the late-breaking clinical trials session at the Transcatheter Cardiovascular Therapeutics (TCT) conference.
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