November 21st, 2012
HeartWare LVAD Approved By FDA For Transplant Patients
Larry Husten, PHD
The FDA said today that it had granted approval to the HeartWare Ventricular Assist System for use in heart failure patients waiting for a transplant. Approval of the device had been expected after the FDA’s Circulatory System Devices panel recommended approval of the device earlier this year. HeartWare was approved based on data from the pivotal ADVANCE trial, in which 140 […]
September 7th, 2012
News Briefs: Cholesterol Trends, AHA Late-Breakers, FDA Updates On Rivaroxaban And Heartware HVAD
Larry Husten, PHD
Cholesterol Trends The Centers for Disease Control issued a new report with the latest details about the prevalence of cholesterol screening and high blood cholesterol in U.S. adults. Here is their summary of the key findings: …cholesterol screening increased from 72.7% in 2005 to 76.0% in 2009, whereas the percentage of those screened who reported being told […]
April 26th, 2012
FDA Advisory Panel Gives Green Light to HeartWare Ventricular Assist System
Larry Husten, PHD
The FDA’s Circulatory System Devices panel voted 9-2 on Wednesday to recommend approval of the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure. The panel agreed unanimously (11-0) that the new device is effective. The panel was more divided about safety but ultimately voted 8-3 that the device […]
NEJM Journal Watch — Recent Cardiology Articles- Sex-Based Disparity in CABG Outcomes: Are We Moving Toward Parity?
- Can Genetic and Social Risk Scores Improve Cardiac Risk Prediction?
- Extensive Ablation vs. Pulmonary Vein Isolation in Persistent Atrial Fibrillation
- Can a Novel Stent Design Improve Long-Term Outcomes of Percutaneous Coronary Intervention?
- Are Angiographically-Derived Coronary Physiology Measurements Ready for Use in the Cath Lab?