St. Jude: CardioMEMS’ Heart Failure Data Reflects Major Opportunity
This article was originally published in The Gray Sheet
With the publication of the CHAMPION clinical trial results, CardioMEMS and its suitor St. Jude Medical took another step toward leading the pack in what they say is a multi-billion dollar market opportunity in hemodynamic heart failure monitoring.
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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.
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.
The approval is significant as it marks the entry of the first quadripolar pacing system into the U.S. market. But St. Jude may not get as big of a positive gain from the product as previously expected, analysts suggest.