Technology

January 25, 2010 - In a significant development in treating congenital heart disease, the Medtronic Melody Transcatheter Pulmonary Valve today became the first transcatheter valve approved for use by the FDA.

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January 25, 2010 - With more than 3,000 requests for medical devices to get 510(k) clearance each year, the U.S. Food and Drug Administration (FDA) asked the Institute of Medicine (IOM) to conduct a comprehensive study of the process, which is not scheduled to be concluded for another year.

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January 25, 2010 - Heart failure is a serious medical condition, in which the heart muscle progressively loses its ability to pump blood, that affects more than five million people in the United States and results in about 1.1 million hospitalizations and 300,000 deaths each year.

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January 25, 2010 – First-in-man procedures and a feasibility study in Europe were recently initiated for a new minimally invasive aortic valve surgery system.

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January 25, 2010 – Trials for a stent that attracts endothelial progenitor cells show positive results in patients with bifurcation lesions and those with non-ST-segment elevation acute coronary syndrome.

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January 25, 2010 – Direct stenting of the carotid arteries is a feasible technique and is not inferior to predilation, according to a new study published in the International Journal of Cardiology (Feb. 4, 2010, vol. 138, issue 3, pages 233-238).

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January 22, 2010 – CE mark certification was granted this week for the BMEYE ccNexfin, the first noninvasive cardiovascular monitor with Masimo Rainbow SET Pulse CO-Oximetry technology.

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January 22, 2010 - A new study by the University of Michigan Medical School and VA Ann Arbor Health System challenges the medical thinking that the lower the cholesterol, the better. Instead, they suggest tailoring treatment to a patient's overall heart attack risk, by considering all their risk factors, such as age, family history, and smoking status.

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January 22, 2010 - The California Heart Center, the cardiology group that developed the nation’s largest heart transplant program, has joined the Cedars-Sinai Heart Institute.

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Feature | Dave Fornell

The debate over healthcare reform has raised many issues as to why costs have risen so much in recent years. During the debates, comments have been made that device manufacturers are a big factor in driving up costs.

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Technology

Primarily used in the hospital setting, NATRECOR (nesiritide) is used intravenously in patients who have acutely decompensated heart failure with dyspnea (shortness of breath).

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To support anti-coagulation disease management for patients at risk for stroke and other clotting disorders, the CoagNow offers a home monitoring system. It is designed to manage the potential risks associated with warfarin therapy.

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January 21, 2010 – A new minimally invasive therapy using radiofrequency ablation to short-circuit nerves in the kidney arteries shows promise in treating uncontrolled hypertension. The research was presented this week at the International Symposium on Endovascular Therapy (ISET).

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January 21, 2010 - A recent study found generic epoprostenol is a safe and effective therapy alternative to brand name Flolan for patients suffering from pulmonary arterial hypertension (PAH).

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January 21, 2010 – The FDA this week cleared the HeartMate II, a continuous-flow, left ventricular assist device (VAD), as a support for severe heart failure patients who are not acceptable candidates for heart transplantation. The HeartMate II is already FDA-approved for use in patients awaiting further, more complex treatment, such as transplants.

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