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Will Edwards Snatch Defeat From The Jaws Of Its Victory Over Medtronic?

On the heels of a sweeping victory in the courts over its rival Medtronic, Edwards Lifesciences is poised to dominate the TAVR (transcatheter aortic valve replacement) market– the revolutionary new catheter technology that offers some patients with life-threatening aortic valve disease an alternative to chest-splitting surgery. 139 more words

Policy & Ethics

FDA Grants Fast Track Status To Amgen Heart Failure Drug

Amgen announced yesterday that its new chronic heart failure drug ivabradine had been granted fast track status by the FDA. The company said the fast track designation, which is for drugs that treat serious conditions and fill an umet medical need, will aid the development and speed the review of the drug. 10 more words

Policy & Ethics

New Medtronic Heart Valve Threatened By Court Decision

A legal injunction may severely limit the availability in the United States of Medtronic’s CoreValve device, which only received FDA approval earlier this year. The device received abundant praise recently when  64 more words

Policy & Ethics

The Uncertain Future Of A Once Highly Promising Device For Lowering Blood Pressure

Following the spectacular crash and burn of the Symplicity HTN-3 trial at the American College of Cardiology two weeks ago, the future of renal denervation (RDN)– the once highly promising catheter technology that many thought would cure resistant hypertension– appears in doubt. 71 more words

Policy & Ethics

Lancet Editors Raise More Questions About Prominent Harvard Stem Cell Researcher

There’s more trouble for Piero Anversa, the prominent and controversial stem cell researcher.

Today the Lancet issued an expression of concern about an influential, much-cited stem cell paper.  65 more words

Policy & Ethics

Troubled NHLBI TOPCAT Trial Disappoints

Although a significant portion of people with heart failure have preserved ejection fraction, none of the proven heart failure therapies has been shown to be beneficial in this important and growing heart failure subpopulation. 110 more words

Policy & Ethics

Circulation Retracts Paper By Stem Cell Pioneer And Its Own Editor

Following an investigation by Harvard Medical School and Brigham and Women’s Hospital a 2012 paper published in Circulation has been retracted. The “institutional review… determined that the data are sufficiently compromised that a retraction is warranted.” The two senior authors of the paper are Piero Anversa, a pioneering researcher in cardiac stem cells, and Joseph Loscalzo, the editor-in-chief of  22 more words

Policy & Ethics