PLC Systems Inc. (PLCSF), a company focused on innovative medical device technologies, today announced that Dr. Vaikom Mahadevan presented RenalGuard® data during the Interventions for Structure Heart Disease session at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). The data presented supports the further development of RenalGuard Therapy® to minimize Acute Kidney Injury (AKI) in patients undergoing Transcatheter Aortic Valve Implantation (TAVI) procedures.
According to Medtronic, the Export Advance aspiration catheter has received the CE mark. The Export Advance aspiration catheter is not approved for use in the USA. The latest addition to the Export family of aspiration catheters are expected to be exhibited at EuroPCR (May 21–24, Paris, France).
Medtronic has revealed the results of a cost-effectiveness model comparing transcatheter aortic valve implantation (TAVI) with the CoreValve System to medical management. Presented at EuroPCR (21–24 May, Paris, France), the UK-based analysis compared the “real world” Medtronic CoreValve ADVANCE study to the medical management cohort of the PARTNER B study and found that the CoreValve System was cost-effective. Patients participating in this study had severe aortic stenosis and were unable to undergo surgery.
Boston Scientific Corporation (BSX) reports positive results from two trials evaluating new, innovative drug-eluting stent (DES) technologies, which are emerging treatment options for coronary heart disease. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System, and two-year follow-up data from the EVOLVE Trial comparing the safety and effectiveness of the SYNERGY Everolimus-Eluting Bioabsorbable Polymer-Coated Platinum Chromium Coronary Stent System to the PROMUS Element™ Stent System were presented today at the annual EuroPCR Scientific Program in Paris.
On the 21 May, at EuroPCR, Paris, France, new registry data confirmed that the BioMatrix drug-eluting stent family is safe over a 12-month period in a “real-world” population of 5559 patients.
OrbusNeich( http://www.orbusneich.com ) today announced that the company s Genous Stent is associated with a significantly lower rate of binary restenosis compared to bare metal stents (BMS) in low-risk non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients at six months. Data from JACK-EPC, an investigator-initiated randomized study, were published in the June issue of Minerva Cardioangiologica( http://www.minervamedica.it/en/journals/minerva-cardioangiologica/article.php?cod=R05Y2013N03A0301 ).
Claret Medical has announced the publication of an original manuscript by Nicolas Van Mieghem et al—“Histopathology of embolic debris captured during transcatheter aortic valve implantation [TAVI]”. The research was published ahead of print in Circulation on 7 May. The research is the result of collaboration between Erasmus Medical Center, Rotterdam, the Netherlands, and the pathology team of Renu Virmani of the Cardiovascular Pathology Institute, Gaithersburg, USA.
Final 6 and 12-month results of the DIRECT first-in-man clinical study were presented by study principal investigator Dr. Mark Webster at the late-breaking clinical trials session of the EuroPCR meeting yesterday in Paris, France. No patients experienced clinically-driven TLR, TVR or MACE at 6-months, with results sustained through 12-months. It is believed the Svelte drug-eluting stent is the first ever to achieve 0% clinically-driven MACE through 12-months in a independent core-lab and DSMB adjudicated clinical study.
CID SpA have sponsored a symposium at EuroPCR called “Cre8: Welcome back confidence in short dual antiplatelet therapy with effective DES”. The clinical impact of the Demonstr8 data related to Cre8 polymer-free drug-eluting stent is expected to be discussed by the panelists. Chairpersons of the symposium are R Mehran, director of Interventional Cardiovascular Research and Clinical Trials at The Mount Sinai School of Medicine in New York (USA), and O Pachinger, chair of the Department of Cardiology at Medical University of Innsbruck (Austria
Abbott has announced CE mark in Europe for the Xience Xpedition 48 Everolimus Eluting Coronary Stent System. Xience Xpedition 48, according to a company release is available in 48mm which is currently the longest stent.
Abbott (ABT) today announced CE Mark in Europe for the XIENCE Xpedition™ 48 Everolimus Eluting Coronary Stent System, the first-of-its-kind treatment for very long blockages in the vessels that supply blood to the heart due to coronary artery disease (CAD). XIENCE Xpedition 48 leverages the proven design and clinical outcomes of the XIENCE family of drug eluting stents in a unique 48 mm length. Abbott continues to offer physicians more options for the treatment of patients with complex coronary artery disease and is the only major manufacturer to offer a coronary drug eluting stent greater than 38 mm in length. XIENCE Xpedition 48 is the latest in a long history of stent innovations pioneered by Abbott, which was the first company to offer physicians size-specific metallic stents for use in small and large vessels of the heart.
InspireMD, Inc. ("InspireMD" or the "Company") (NYSE MKT: NSPR), the leader in embolic protection stents, today announced new 6-month results from the MASTER (MGuard for Acute ST Elevation Reperfusion) trial demonstrating that the MGuard Embolic Protection Stent (EPS) outperformed bare metal and drug eluting stents in all-cause mortality in ST segment elevation myocardial infarction (STEMI) patients. Results from the trial were presented at the InspireMD STEMI Symposium at EuroPCR, the official annual meeting of the European Association for Percutaneous Cardiovascular Interventions (EAPCI) taking place in Paris from May 21-24, 2013.
Cardiovascular Systems is expected to present late-breaking data from its ORBIT II study of coronary artery disease at EuroPCR in Paris, France, 21–24 May.
On the 21 May 2013 at EuroPCR, Paris, France, one-year results from SOURCE XT (one of the largest, post-approval transcatheter aortic valve implantation (TAVI) registries to-date) has reported good clinical outcomes in routine clinical practice, with high rates of device success for all access approaches, valve sizes and delivery systems.
Neovasc Inc. (NVC.V), a developer of novel technologies to treat vascular disease, today reported initial data from open label patient Registries that are tracking the progress of refractory angina patients implanted with the Neovasc ReducerTM, a novel percutaneous device that is CE marked in the European Union for the treatment of refractory angina. The data were presented at EuroPCR 2013, the annual meeting of the European Association for Percutaneous Cardiovascular Interventions.
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