CardioExchange Archive

October 17th, 2011

Sapien Transcatheter Heart Valve Might Be Delayed

Larry Husten, PHD

Approval for the highly anticipated Sapien transcatheter aortic heart valve might be delayed for 6 months, until April 2012. The FDA had been expected to reach a decision this month. But now a member of the FDA advisory panel that recommended approval for Sapien, Jeffrey Borer, in a public statement made at the ACC/AATS Heart […]

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October 14th, 2011

FDA Advisory Panel Recommends First DES For PAD

Larry Husten, PHD

The FDA Circulatory System Devices Panel voted 11-0 on Thursday to support the premarket approval application for the Zilver PTX drug-eluting stent, manufactured by Cook Medical. The self-expanding, paclitaxel-coated stent would be the first DES approved for use in peripheral arterial disease of the above-the-knee femoropopliteal arteries. Cook Medical press release

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October 13th, 2011

Coronary Heart Disease Prevalence in U.S. Continues to Decline

Larry Husten, PHD

The prevalence of coronary heart disease in the U.S. continues to drop, according to the CDC. Data from the Behavioral Risk Factor Surveillance System (BRFSS) surveys, published in Morbidity and Mortality Weekly Report, show a significant decrease in overall CHD prevalence from 6.7% to 6% from 2006 to 2010. In an apparent paradox, the authors note that the decline […]

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October 13th, 2011

National Lipid Association Expert Panel Has Many Deep Ties To Industry

Larry Husten, PHD

[Editor’s note: see here for a reply post to this news story by Chrstopher Seymour, MBA, Executive Director of the National Lipid Association]. An “expert panel” assembled by the National Lipid Association (NLA) is recommending a dramatic expansion in the use of new biomarkers for the diagnosis and management of cardiovascular disease. The recommendations, if widely adopted, […]

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October 11th, 2011

Cardiologist Who Accused Famed Surgeon of Misconduct Is Fired by Northwestern University

Larry Husten, PHD

Northwestern University has dismissed the cardiologist who raised troubling questions about Patrick McCarthy, its star cardiac surgeon. The controversy began in 2008 when Nalini Rajamannan, an assistant professor of medicine, accused McCarthy of implanting in one of her patients an experimental annuloplasty ring, the Myxo ring, manufactured by Edwards Lifesciences. McCarthy, who had invented the device, […]

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October 10th, 2011

TTOP-AF Trial Proves Efficacy of RF Ablation System, But Not Safety

Larry Husten, PHD

A new trial demonstrates that an investigational RF ablation system is more effective than medical management in treating persistent AF, but the trial failed to meet a key predefined safety goal. At the Venice Arrhythmias 2011 conference, Lucas Boersma presented the results of the TTOP-AF (Tailored Treatment of Persistent Atrial Fibrillation) trial, in which 210 patients […]

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October 7th, 2011

FDA Approves Juvisync, Combination of Sitagliptin and Simvastatin

Larry Husten, PHD

The FDA has approved a fixed-dose combination tablet consisting of sitagliptin and simvastatin, two drugs previously approved for type 2 diabetes and hypercholesterolemia. Merck will market the new drug as Juvisync. “This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet,” said Mary H. Parks, the […]

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October 6th, 2011

J&J Pleads Guilty, Pays $85 Million to Settle Natrecor Case

Larry Husten, PHD

The U.S. Department of Justice announced that Johnson & Johnson has pleaded guilty to a misdemeanor and has agreed to pay an $85 million criminal fine to settle charges about the company’s marketing of Natrecor (nesiritide) for off-label use. The government said that Scios, the J&J subsidiary that marketed the drug, “admitted that it intended Natrecor to […]

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October 6th, 2011

Rivaroxaban Roundup: ATLAS-ACS an AHA Late-Breaker, NEJM Perspective, NYT Overview

Larry Husten, PHD

Rivaroxaban (Xarelto, Bayer and Johnson & Johnson) is in the news today. In a rare move, the AHA has added the ATLAS ACS 2-TIMI 51 trial to its roster of Late-Breaking Clinical Trials to be presented next month at the AHA’s Scientific Sessions in Orlando. C. Michael Gibson will present the results on Sunday, November 13, at 5:13 PM. Last week, Bayer […]

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October 4th, 2011

Same-Day Discharge After PCI: Safe but Rarely Used

Larry Husten, PHD

Same-day discharge after low-risk PCI is safe but only rarely used, according to a study published in JAMA. Sunil Rao and colleagues analyzed data from 107,018 Medicare patients who underwent PCI at sites taking part in the CathPCI Registry. Only a small percentage (1.25%)  of patients in the study were discharged on the day of the procedure. […]

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