CardioMEMS’ Heart Failure Monitor Foiled At Panel By FDA Inspection Findings Of Study Bias
This article was originally published in The Gray Sheet
Executive Summary
The firm’s PMA hopes are in question after recommendations made by company nurses to investigators in the CHAMPION trial, uncovered during FDA clinical-site inspections, dominated last week’s advisory panel meeting. The panel voted 6-4 that the benefits of the device do not outweigh its risks.
You may also be interested in...
CardioMEMS Has Better Luck With FDA Advisory Panel Second Time Around
FDA’s Circulatory System Devices panel wrestled with a new analysis of the CHAMPION trial of the Champion heart failure monitor Oct. 9. CardioMEMS was banking that the new analysis would eliminate the doubts about possible bias that undermined the company’s first effort to earn FDA approval in 2011.
NICE Briefs: Oncotype Dx; Implantable Heart Failure Monitors; Endobronchial Valves; RF Ablation
The U.K.’s National Institute for Health and Care Excellence (NICE) gives a thumbs-up to Genomic Health’s Oncotype DX test for breast cancer, and offers cautious support for implantable pulmonary artery pressure monitors in heart failure patients and endobronchial valves in emphysema patients. More NICE news.
News Briefs: FDA Program Alignment Group; CardioMEMS Panel; HCV Coverage Analysis
FDA announces the formation of a new Program Alignment Group, made up of center directors and other officials, and schedules an workshop on intraocular lenses. The agency’s Circulatory System Devices panel will review CardioMEMS’ pulmonary monitoring system again and Medtronic devices. CMS opens coverage analysis for hepatitis C screening. More news.