Estudian una nueva técnica quirúrgica que disminuye el riesgo de fibrilación auricular tras la cirugía coronaria. La investigación ha sido presentada como comunicación y opta a premio en el XXI Congreso de la Sociedad Española de Cirugía Torácica-Cardiovascular (SECTCV).
Stentys has announced that it has enrolled the first patient in its APPOSITION IV clinical study using its new Self-Apposing Sirolimus-eluting stent. The randomised study will enrol 150 heart attack patients who will be treated with either the Stentys stent or Medtronic s Resolute drug-eluting stent, and will compare stent apposition in both groups at four and nine months after treatment.
Nearly 50% of patients suffering from a diseased mitral heart valve with severe, symptomatic regurgitation are denied open-heart surgery because it is considered too risky; in the future, Transcatheter Mitral Valve Implantation (TMVI) may offer new hope for these patients.
Svelte® Medical Systems today announced the start of the FAASTER (First Assessment of the Acrobat Stenting Technique European Post-Market Registry) study in clinical sites across Europe. FAASTER is a real world, multi-center registry assessing the procedural success and resource utilization associated with the Svelte coronary stent mounted on an Integrated Delivery System (IDS) in relation to target lesion and vessel complexity (as defined by NAVI-score) and selected catheter approach (diagnostic or guiding). Up to 1,500 patients will be evaluated in the study.
STENTYS S.A. (STNT.PA),a medical technology company commercializing the world s first and only Self-Apposing® Stent to treat Acute Myocardial Infarction (AMI), announced today that it has enrolled the first patient in its APPOSITION IV clinical study using its new Self-Apposing® Sirolimus-eluting stent. The randomized study will enroll 150 heart attack patients who will be treated with either the STENTYS stent or Medtronic s Resolute® drug-eluting stent, and will compare stent apposition in both groups at four and nine months after treatment.
An FDA advisory panel has voted 11-0, with one abstention, to recommend expanding the indication for the Sapien Transcatheter Heart Valve to include high-risk patients with severe aortic stenosis. The FDAs Circulatory Systems Advisory Committee agreed Wednesday that Edwards Lifesciences Sapien valve is safe and effective for patients who are candidates for aortic valve replacement but who have an open-heart surgery mortality risk of 15% or more. The Sapien was approved in 2011 for inoperable patients, but Edwards is seeking the broader "high-risk" indication, which would allow the device to be a treatment option for a greater number of patients.
Cardiosolutions Inc., an emerging leader in structural heart solutions for valvular heart disease, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Dexterity™ Steerable Introducer, a next generation structural heart access introducer and delivery conduit. The Dexterity™ Steerable Introducer is designed to provide physicians straightforward and uncomplicated access to the heart anatomy by simplifying the cardiac trans-septal procedure and facilitating passage of therapies into the entire left atrium, left ventricle and associated heart structures. The Dexterity™ Steerable Introducer is intended to be used for the advancement and delivery of various cardiovascular catheters into the heart, including the left side of the cardiac anatomy through the inter-atrial septum.
Presentations at EuroPCR 2012 Enjoy Spirited Debate; Implications for Clinical Practice of Interventional Cardiologists
Development of more biocompatible polymers, as well as thinner stent struts and polymer coatings, is improving efficacy and safety of second-generation drug-eluting stents (DES). Given the link between certain polymers and chronic inflammatory responses to DES, it is a natural next step to develop either a third-generation bioresorbable polymer on a durable platform or a fourth-generation bioresorbable polymer on a bioresorbable platform.
The demonstration at the RSA security conference in San Francisco was a genuine attention-getter. A program launched by the push of a computer key breeched the security credentials of an infusion pump strapped to an onstage “diabetic” mannequin and instructed the device to dump what would be a lethal insulin dose into the dummy s “bloodstream.”
A recent paper, published online before print in SCAI s journal, Catheterization and Cardiovascular Interventions, yet again adds to the evidence that intravascular ultrasound (IVUS) imaging during PCI can improve stent placement and expansion in a way that may prevent stent thrombosis (ST).
Un equipo de Japón y Holanda asegura que un estudio durante más de 10 años prueba la seguridad del primer stent coronario completamente biodegradable fabricado con ácido poli l-láctico (PLLA). "Nuestro estudio garantiza con solvencia el uso futuro de los stent liberadores de fármacos (DES, por su nombre en inglés) biodegradables", dijo el doctor Kunihiko Kosuga.
This is a brief overview of information related to FDA s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA s approval.
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