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Abbott began enrolling U.S. patients in the EXCEL trial, which will compare the use of the Xience Prime or Xience V drug-eluting strents to coronary artery bypass graft (CABG) surgery for effectiveness of left main revascularization. The large-scale trial will attempt to show stenting has comparable or superior outcomes to CABG, which has long been the dream of interventional cardiology.

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October 4, 2011 – Roche announced plans today to expand its coagulation testing product line in North America beyond physician offices and outpatient clinics with the development of a full line of coagulation analyzers for hospital and reference laboratories. The new line is expected to be introduced in the United States and Canada in 2014, subject to regulatory approval and other requirements.

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October 4, 2011 – The International Contrast Ultrasound Society (ICUS) submitted a petition this week to the U.S. Food and Drug Administration (FDA) requesting removal of the boxed warnings on ultrasound contrast agents. The members of the group say this would bring the product labeling into line with the current body of scientific research, which it says clearly demonstrates the safety and clinical benefits of these imaging products.

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Toshiba America Medical Systems will showcase the Infinix VF-i bi-plane angiography system with dual 12”x12” mid-size ...

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October 3, 2011 – Maquet Cardiovascular has signed a definitive agreement to acquire Atrium Medical Corp. for $680 million. Atrium is a medical device technologies developer for interventional cardiology and radiology, chest trauma care and thoracic drainage, vascular surgery and general surgery. Atrium will operate as an independent, self-contained business unit of Maquet and will be led by current Atrium president Trevor Carlton.

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October 3, 2011 —The American Society of Echocardiography (ASE) has published guidelines for new applications for echocardiography in the neonatal intensive care unit (NICU). An expert consensus statement, “Targeted Neonatal Echocardiography in the Neonatal Intensive Care Unit: Practice Guidelines and Recommendations for Training,” has been published in the October 2011 issue of JASE, the ASE’s monthly journal, and is also available online at: www.asecho/guidelines. The document defines the scope and appropriateness of echocardiography in the NICU and defines standards for both the echocardiographic examination and the individuals who perform and interpret these studies.

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October 3, 2011 — Kjaya Medical will debut iShareScan.com, a cloud-based image sharing solution, at RSNA 2011. The site is available at no cost to imaging sites. It enables users to upload images to the Kjaya cloud, where they may be accessed, viewed and manipulated instantaneously in 2-D, 3-D or 4-D by authorized physicians utilizing the company’s advanced remote viewer.

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October 3, 2011 – Up to now, on-the-job hazards for cardiac sonographers were usually limited to overtaxed muscles or incorrect body positioning. And the profession, with help from equipment manufacturers, has made remarkable progress in identifying and lessening these problems. But now, based on discussions initiated on the American Society of Echocardiography’s (ASE) social media website, [email protected] and results of an ASE survey, there appear to be growing concerns about radiation exposure. As October is Medical Ultrasound Awareness Month, the ASE believes it is appropriate to address this emerging concern for cardiovascular sonographers. Are sonographers getting more radiation on the job than is acceptable for their health?

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October 3, 2011 — JenaValve Technology GmbH, a German medical device company specializing in the development of transcatheter heart valve implantation (TAVI) systems, announced it has received CE mark approval for its transapical TAVI system of the second-generation. This system is used to treat severe aortic valve stenosis in elderly high-risk patients, especially in patients for whom conventional open-heart surgery is not an option.

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October 3, 2011 – Cardiac Dimensions Inc. announced it received European CE mark approval for a newly enhanced version of its Carillon Mitral Contour System, a therapy for treating heart failure patients suffering from functional mitral regurgitation (FMR). Receipt of the CE mark enables Cardiac Dimensions to initiate a commercial launch of the enhanced device in Europe, which will begin in 2012.

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October 3, 2011 – Boston Scientific has enrolled the first patients in its NECTAR-HF (NEural Cardiac TherApy foR Heart Failure) clinical trial. NECTAR-HF is a prospective, randomized, international clinical feasibility study designed to assess preliminary safety and efficacy of chronic vagal nerve stimulation in heart failure patients. The study will evaluate 96 patients with vagal nerve stimulator implants at multiple centers in Europe.

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October 3, 2011 – Researchers from MIT’s Computer Science and Artificial Intelligence Laboratory (CSAIL), the University of Michigan, Brigham and Women’s Hospital in Boston and Harvard Medical School have developed a new tool that can more accurately determine risk of death in patients who have suffered a heart attack. Results of the study could prove life saving for the millions of Americans who suffer heart attacks every year.

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September 30, 2011 – Cambridge Heart Inc. announced its HearTwave II System was cleared for sale by the Mexican regulatory authorities. In August 2010, the company executed an exclusive distribution agreement with Mayerick S.A. de S.V. to distribute the system, including the company’s microvolt t-wave alternans (MTWA) software and micro-V alternans sensors. This addition represents the company’s first distribution agreement in Latin America.

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September 30, 2011 — The American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) released an updated guideline for the diagnosis and management of peripheral artery disease (PAD). The goal is to help guide clinical decision-making related to PAD and improve patient outcomes.

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September 30, 2011 — Boston Scientific Corp. said the U.S. Court of Appeals for the Federal Circuit found in favor of the company in a 1998 stent patent infringement suit involving Johnson & Johnson.

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