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Monday, April 16, 2012

ACC: Novel therapy lowers LDL-C by 72%

A novel monoclonal antibody lowered low density lipoprotein cholesterol (LDL-C) up to 72 percent in patients with primary hypercholesterolemia in a randomized, double-blind, placebo-controlled trial. The results were announced March 26 at the American College of Cardiology’s 61st scientific session and simultaneously published online in the Journal of the American College of Cardiology.

“This was a very sophisticated trial that gleaned a lot of information,” said co-author Dean J. Kereiakes, MD, medical director of The Christ Hospital Heart and Vascular Center in Cincinnati, in an interview. The study was designed to test the safety and efficacy of the human monoclonal antibody SAR236553/REGN727.

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After an Unprecedented Request for a Retraction, A Close Look at the Data

Guest Post from Edward J. Schloss, MD, the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

Last week, St. Jude Medical took the unusual step of requesting a retraction of an article accepted for publication in Heart Rhythm Journal. In this article Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads, Dr. Robert Hauser et al analyzed patient deaths in the FDA MAUDE database associated with St. Jude Medical and Medtronic ICD leads. This week, Dr. Douglas Zipes, Heart Rhythm editor, declined that request. (Please see my previous Cardiobrief coverage of Hauser’s article.)

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Friday, April 13, 2012

Medtronic Initiates Landmark U.S. Drug-Eluting Balloon Study

Expanding its commitment to developing innovative treatments for cardiovascular disease and the evidence to support their adoption, Medtronic, Inc. /quotes/zigman/233680/quotes/nls/mdt MDT -1.16% announced today the start of the Medtronic IN.PACT SFA II study, the company’s first U.S. clinical trial for its line of IN.PACT drug-eluting balloons.

The first patients in this landmark study were treated this week by Dr. Ash Jain at Washington Hospital in Fremont, Calif., and Dr. Brian Bigelow at St. Vincent Hospital in Indianapolis; Dr. Monica Hunter at Christ Hospital in Cincinnati is planning to treat a patient in the study as early as next week. Drs. Jain, Bigelow and Hunter are the principal investigators at their respective trial site.

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